| Trial | Phase | Enrollment | Study Type | Start Date | Status |
|---|
| [NCT01131572] | Phase 2/Phase 3 | 11 participants (Actual) | Interventional | 2010-02-28 | Terminated |
| Supportive Measures in Treatment of Aluminum Phosphide Poisoning as a Trial to Reduce Mortality at Assiut University Hospital [NCT03879356] | Phase 4 | 44 participants (Actual) | Interventional | 2016-01-01 | Completed |
| N-AcetylCysteine as a Potential Treatment of Methamphetamine Dependence [NCT01063205] | Phase 1 | 10 participants (Actual) | Interventional | 2010-03-31 | Completed |
| Effect of N-Acetyl Cysteine on Expression of HOXA Cluster Genes in Endometrium of Women With Recurrent Implantation Failure (RIF) During Implantation Window: a Double-blinded Randomized Research [NCT03862586] | Phase 3 | 40 participants (Actual) | Interventional | 2015-02-01 | Completed |
| Randomized Controlled Trial of N-acetylcysteine and Acetazolamide in Treatment of Chronic Mountain Sickness [NCT01187108] | Phase 1/Phase 2 | 85 participants (Actual) | Interventional | 2013-06-30 | Completed |
| N-Acetyl Cysteine in the Prevention of Contrast Induced Nephropathy in Cirrhosis of Liver-NEPHRO Trial [NCT03759158] | | 100 participants (Actual) | Interventional | 2018-12-01 | Completed |
| N-Acetylcysteine in the Treatment of Deliberate Self-Harm in Adolescents: An Open Label Pilot Study [NCT01111734] | Phase 1 | 67 participants (Actual) | Interventional | 2011-03-31 | Completed |
| A Randomized Prospective Trial of N-acetyl Cystein in Patients With Peritoneal Dialysis [NCT01111422] | Phase 4 | 66 participants (Anticipated) | Interventional | 2010-03-31 | Recruiting |
| The Evaluation of the Protective Effect of N-Acetylcysteine Against Drug Induced Ototoxicity in Peritoneal Dialysis Patients [NCT01131468] | Phase 2 | 60 participants (Actual) | Interventional | 2008-02-29 | Completed |
| Study for Evaluation of the Immune Response of Visceral Leishmaniasis Patients Treated With Antimonial Pentavalent Associated to N-Acetylcysteine [NCT01138956] | | 40 participants (Anticipated) | Interventional | 2010-04-30 | Recruiting |
| Randomized Controlled Trial of N-acetyl Cysteine as a Neuroprotective Agent in Progressive Multiple Sclerosis [NCT05122559] | Phase 2 | 98 participants (Anticipated) | Interventional | 2022-02-16 | Recruiting |
| Antioxidant Therapy With N-acetylcysteine for Motor Behavior and/or Learning in Children With Neurofibromatosis Type 1 [NCT04481048] | Phase 2 | 58 participants (Anticipated) | Interventional | 2020-12-15 | Recruiting |
| Nutrition, Neuromuscular Electrical Stimulation (NMES) and Secondary Progressive Multiple Sclerosis (SPMS) [NCT01381354] | Phase 1 | 38 participants (Actual) | Interventional | 2010-10-31 | Completed |
| Effect of N-acetyl Cysteine on Oxidative Stress Biochemical Factors and IVF/ICSI Outcomes in Women With Endometrioma: A Randomized, Double-blinded, Phase III Clinical Trial [NCT05460858] | Phase 3 | 140 participants (Anticipated) | Interventional | 2021-04-13 | Recruiting |
| Antioxidants for Preventing Contrast-Induced Acute Kidney Injury After Coronary Artery Catheterization [NCT03755700] | Phase 3 | 1,000 participants (Anticipated) | Interventional | 2018-11-01 | Recruiting |
| Effect of N-acetylcysteine on the Acute Cognitive Effects of Delta-9-Tetrahydrocannabinol [NCT02335060] | Early Phase 1 | 5 participants (Actual) | Interventional | 2014-05-02 | Terminated(stopped due to Feasibility pilot was completed) |
| Effects of Prolonged N-acetylcysteine Administration on Foot Ulcer Oxygenation in Diabetic Patients [NCT01082445] | Phase 3 | 100 participants (Actual) | Interventional | 2009-08-31 | Completed |
| Neuroinflammation as a Novel Target to Treat Bipolar Depression: A Pilot PET Study With [11C]PBR-28 and N-Acetyl Cysteine (NAC) Antidepressant Treatment [NCT03730064] | Early Phase 1 | 3 participants (Actual) | Interventional | 2018-11-01 | Completed |
| Phase I Dose Escalation Study of N-acetylcysteine (NAC) Administered Intravenously (IV) in Conjunction With Intraperitoneal (IP) Administered Cisplatin and IV/IP Paclitaxel in Patients With Stage III or IV Ovarian Cancer [NCT01138137] | Phase 1 | 0 participants (Actual) | Interventional | 2010-06-30 | Withdrawn(stopped due to No funding was available for the cost of the IV N-acetylcysteine (NAC).) |
| Comparative Evaluation of Standard Prophylaxis Versus Divided-dose NSAIDs or Hybrid NSAID and N-acetylcysteine Therapy for the Prevention of Post-ERCP Pancreatitis [NCT03708458] | Phase 4 | 250 participants (Anticipated) | Interventional | 2017-04-01 | Recruiting |
| Effects of Oral N-Acetyl-Cysteine (NAC) in the Early Phase of Schizophrenia Spectrum Psychosis: Randomized, Parallel, Double- Blind, Placebo Controlled Trial [NCT01354132] | Phase 2 | 20 participants (Actual) | Interventional | 2011-05-31 | Completed |
| Reducing Respiratory Symptoms of Pulmonary Irradiation in Interstitial Lung Disease: A 2x2 Factorial Randomized Phase II Trial Testing N-Acetyl Cysteine and Dexamethasone [NCT05986318] | Phase 2 | 98 participants (Anticipated) | Interventional | 2023-12-01 | Not yet recruiting |
| The Effect of N_acetylcystein as an Antioxidant on Iron Overload and Frequency of Blood Transfusion in β-thalassemia Major Patients at Assiut Childern Hospital University [NCT05777733] | Phase 1 | 100 participants (Anticipated) | Interventional | 2024-03-23 | Not yet recruiting |
| Overcoming Membrane Transporters to Improve CNS Drug Delivery [NCT01322009] | Phase 1/Phase 2 | 14 participants (Actual) | Interventional | 2011-03-31 | Completed |
| Macrophage Activation, Assessed by Macrophage Markers Soluble CD163 and Soluble CD206, as Indication of Early Liver Cell Damage in Paracetamol Overdose [NCT03679442] | Phase 1 | 16 participants (Actual) | Interventional | 2014-09-08 | Completed |
| Prospective Randomized, Double-blind Controlled Clinical Study of N-acetylcysteine for Treatment of Dryness Symptoms Due to Primary Sjogren's Syndrome [NCT04793646] | | 60 participants (Anticipated) | Interventional | 2021-04-30 | Active, not recruiting |
| Effect of a Multi-ingredient of L-Histidine, L-Serine, L-Carnosine and N-Acetylcysteine on Visceral Adiposity and Non-alcoholic Fatty Liver Disease in Individuals With Abdominal Obesity. Randomized, Parallel, Placebo Controlled, Triple Blind Study. [NCT05807204] | | 20 participants (Actual) | Interventional | 2023-05-01 | Active, not recruiting |
| Effect of N-acetyl Cysteine on Non Alcoholic Fatty Liver Disease in Obese Children [NCT02117700] | Phase 1/Phase 2 | 14 participants (Actual) | Interventional | 2015-04-30 | Completed |
| A Prospective Randomized Controlled Trial of Adjunctive N-acetylcysteine (NAC) in Adult Patients With Pulmonary Tuberculosis: a Sub-study of TB Sequel [NCT03702738] | Phase 2 | 110 participants (Anticipated) | Interventional | 2019-03-01 | Recruiting |
| Comparative Evaluation of the Effect of Theophylline Plus N-acetylcysteine, Theophylline Alone, and N-acetylcysteine Alone in Preventing Contrast-induced Nephropathy in Patients With Moderate to High Risk Undergoing Coronary Angiographic Procedures [NCT02088502] | Phase 2/Phase 3 | 96 participants (Anticipated) | Interventional | 2013-09-30 | Recruiting |
| Multimodal Prevention of First Psychotic Episode - a 2x2-Factorial Randomized Trial Investigating the Efficacy of Acetylcysteine and Integrated Preventive Psychological Intervention in Subjects Clinically at High Risk for Psychosis [NCT03149107] | Phase 3 | 48 participants (Actual) | Interventional | 2016-09-01 | Terminated(stopped due to Recruitment not sufficient) |
| N-Acetylcysteine for Smoking Cessation in Tobacco and Cannabis Co-Use: A Randomized Controlled Trial [NCT04627922] | Phase 4 | 60 participants (Anticipated) | Interventional | 2021-08-25 | Recruiting |
| Intratumoral Bromelain + N-acetylcysteine in Relapsed and Unresectable Pseudomyxoma Peritonei. Phase I Single-arm Trial [NCT04982146] | Phase 1 | 10 participants (Anticipated) | Interventional | 2021-09-13 | Active, not recruiting |
| A Phase 2 Randomized, Placebo- Controlled, Parallel Group, Double Blinded Single Center Study on Effect of N-acetyl Cysteine Compared to Placebo on Fatigue in Patients With Progressive Multiple Sclerosis [NCT02804594] | Phase 2 | 15 participants (Actual) | Interventional | 2016-10-01 | Completed |
| The Effects of N-Acetylcysteine on Oxidative Stress Markers in Chronic Obstructive Pulmonary Disease (COPD) [NCT03956888] | Phase 3 | 30 participants (Anticipated) | Interventional | 2019-06-01 | Not yet recruiting |
| A Randomised Controlled Trial of Intravenous N-acetylcysteine in the Management of Antituberculous Drug-induced Hepatitis [NCT02182167] | Phase 2/Phase 3 | 102 participants (Actual) | Interventional | 2014-05-31 | Completed |
| Safety of Low Dose Intravenous Contrast 64 Multi-Detector Computed Tomography Scanning in Patients With Chronic Kidney Disease [NCT02476526] | Phase 4 | 50 participants (Actual) | Interventional | 2008-09-30 | Completed |
| Oxidative Stress and Surgical Recovery [NCT04732000] | Phase 2 | 21 participants (Actual) | Interventional | 2021-07-01 | Active, not recruiting |
| Efficacy and Safety of N-acetylcysteine (NAC) in Patients With Mild Vascular Cognitive Impairment [NCT03306979] | Phase 2 | 60 participants (Anticipated) | Interventional | 2018-04-30 | Recruiting |
| Safety of Nebulized Combination Therapy BromAc® in COVID-19 Respiratory Disease: a Phase 1 Study [NCT05258682] | Phase 1/Phase 2 | 30 participants (Anticipated) | Interventional | 2022-05-01 | Not yet recruiting |
| Targeting Reactive Oxygen Species Production as a Novel Therapeutic in Fuch's Endothelial Corneal Dystrophy [NCT04440280] | Phase 2 | 45 participants (Anticipated) | Interventional | 2020-09-16 | Recruiting |
| N-Acetyl-Cysteine for Healing of Amputation Stumps in the Setting of Diabetes [NCT03253328] | | 50 participants (Anticipated) | Interventional | 2016-12-15 | Suspended(stopped due to No one is currently receiving treatment and enrollment is of course on hold. Subjects being unblinded to perform interim analysis.) |
| A Phase 2, Multi-centre Study of BromAc for Recurrent Peritoneal Mucinous Tumour or Pseudomyxoma Peritonei [NCT03976973] | Phase 2 | 62 participants (Anticipated) | Interventional | 2022-05-31 | Not yet recruiting |
| A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N-Acetylcysteine in Patients With Idiopathic Pulmonary Fibrosis With Background Treatment of Pirfenidone [NCT02707640] | Phase 2 | 123 participants (Actual) | Interventional | 2013-08-31 | Completed |
| Glial Regulators for Treating Comorbid Posttraumatic Stress Disorder and Substance Use Disorders [NCT02911285] | Phase 2 | 90 participants (Actual) | Interventional | 2016-10-31 | Completed |
| Pilot Double Blinded Randomized Placebo Controlled Multi Central Clinical Trial on Inflammatory Regulation Effect of NAC on COVID-19 [NCT04455243] | Phase 3 | 1,180 participants (Anticipated) | Interventional | 2020-08-01 | Not yet recruiting |
| ACETAMINOPHEN ANTINOCICEPTIVE EFFECT WHEN ASSOCIATED WITH N-ACETYLCYSTENEINE [NCT02206178] | Phase 1 | 24 participants (Actual) | Interventional | 2013-09-30 | Completed |
| Study of the Effect of Acetylcysteine on Inflammation Biomarkers in Pediatric Acute Pyelonephritis. [NCT02080182] | Phase 2 | 70 participants (Actual) | Interventional | 2014-01-31 | Completed |
| Treatment of Systemic Lupus Erythematosus (SLE) With N-acetylcysteine (NAC) (SNAC) [NCT00775476] | Phase 2 | 290 participants (Anticipated) | Interventional | 2022-03-31 | Recruiting |
| Effectiveness of Routine Nebulization of Mucolytics and Bronchodilators in Mechanically Ventilated Intensive Care Patients' [NCT02159196] | | 950 participants (Actual) | Interventional | 2014-07-31 | Completed |
| Mechanisms of Oxidative Stress During N-Acetyl Cysteine (NAC) Supplementation in Veterans With Gulf War Illness (GWI) [NCT04987775] | Early Phase 1 | 170 participants (Anticipated) | Interventional | 2023-11-30 | Recruiting |
| N-acetyl Cysteine as an Adjuvant Therapy to Laparoscopic Ovarian Drilling in Clomiphene Citrate Resistant Polycystic Ovary Syndrome [NCT02239107] | Phase 4 | 70 participants (Actual) | Interventional | 2012-01-31 | Completed |
| Glutathione, Brain Metabolism and Inflammation in Alzheimer's Disease [NCT04740580] | Early Phase 1 | 52 participants (Anticipated) | Interventional | 2022-02-15 | Recruiting |
| A Pilot Study of N-acetylcysteine for Alcohol Use Disorder [NCT04964843] | Phase 2 | 0 participants (Actual) | Interventional | 2023-04-30 | Withdrawn(stopped due to Null results were posted from a neurometabolite study and a recent trial for AUD. Study may resume if more positive data emerge.) |
| Evaluating N-acetylcysteine as a Pharmacotherapy for Tobacco Use Disorder [NCT02737358] | Phase 2 | 114 participants (Actual) | Interventional | 2016-08-30 | Completed |
| TOLERANCE STUDY OF N-ACETYLCYSTEINE FOR THROMBOLYSIS IN THE ACUTE PHASE OF ISCHEMIC STROKE / ETUDE DE TOLERANCE DE LA N-ACETYLCYSTEINE POUR LA THROMBOLYSE A LA PHASE AIGUË DE L'INFARCTUS CEREBRAL [NCT04920448] | Phase 2 | 19 participants (Anticipated) | Interventional | 2021-06-07 | Not yet recruiting |
| Efficacy and Safety of the Combination of Acetylcysteine, Paracetamol and Phenylephrine for the Treatment of Common Cold: a Prospective, Randomized, Double-blind, Controlled Trial [NCT05070650] | Phase 3 | 1,002 participants (Anticipated) | Interventional | 2024-09-20 | Not yet recruiting |
| Pilot Study of N-acetyl Cysteine for Refractory Generalized Epilepsy in Children With Autism [NCT02054949] | | 0 participants (Actual) | Interventional | 2013-04-30 | Withdrawn(stopped due to no eligible subjects located) |
| Phase II: Physiological Effects of Nutritional Support in Patients With Parkinson's Disease [NCT04459052] | Phase 2 | 50 participants (Anticipated) | Interventional | 2020-04-30 | Recruiting |
| The Combination of Atorvastatin, Acetylcysteine and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia [NCT03460808] | Phase 1/Phase 2 | 200 participants (Anticipated) | Interventional | 2018-03-10 | Not yet recruiting |
| Randomized Controlled Clinical Trial of Antioxidant Therapy in Critically Ill Patients With Septic Shock: Analysis Before and After Treatment of the Oxidative Stress [NCT03557229] | Phase 3 | 131 participants (Anticipated) | Interventional | 2018-07-23 | Active, not recruiting |
| Evaluation of N-Acetylcysteine Efficacy to Reduce the Craving and to Prolong THE Abstinence Time of Coca Paste [NCT03556371] | Phase 2 | 140 participants (Actual) | Interventional | 2018-04-09 | Completed |
| A Dose-Finding Study of N-Acetylcysteine (NAC) to Prevent Cisplatin-induced Hearing Loss in Children With Cancer [NCT02094625] | Phase 1 | 52 participants (Actual) | Interventional | 2016-03-31 | Completed |
| The Efficacy of N-acetylcysteine as a Cessation Treatment for Tobacco Smoking and Oxidative Stress Reduction [NCT02124525] | Phase 3 | 32 participants (Anticipated) | Interventional | 2013-02-28 | Recruiting |
| Evaluation of the Effect in Platelet Count of Atorvastatin and N-acetyl Cysteine in Patients With Primary Immune Thrombocytopenia Resistant to Steroid Treatment or in Relapse: An Exploratory Clinical Trial [NCT05551624] | Early Phase 1 | 15 participants (Actual) | Interventional | 2018-07-04 | Completed |
| A Prospective Randomized Controlled Study for Intervention of Prolonged Isolated Thrombocytopenia After Allogeneic Hematopoietic Stem Cell Transplantation: N-acetyl-L-cysteine (NAC) Versus Supportive Therapy [NCT03391856] | Phase 2/Phase 3 | 15 participants (Actual) | Interventional | 2018-03-01 | Terminated(stopped due to protocol changed) |
| Pilot Study: Postoperative Pain Reduction by Pre Emptive N-Acetylcysteine [NCT03354572] | Phase 4 | 60 participants (Actual) | Interventional | 2017-10-20 | Completed |
| The Prevention Contrast-Induced Acute Kidney Injury With the Triple Combination of Hydration With Physiological Saline, N-Acetylcysteine and Sodium Bicarbonate [NCT01210456] | Phase 3 | 458 participants (Anticipated) | Interventional | 2009-10-31 | Enrolling by invitation |
| A Randomized Controlled Trial of N-acetylcysteine to Reduce Ischemia/Reperfusion Injury in Liver Resection Performed Under Ischemic Preconditioning and Intermittent Portal Triad Clamping [NCT01223326] | Phase 4 | 46 participants (Actual) | Interventional | 2003-01-31 | Completed |
| A New Biomarker-Based Approach Towards Developing Improved Treatment for Major Depressive Disorder (MDD) Based Upon Targeting Monoamine Oxidase A (MAO-A) [NCT02269540] | Early Phase 1 | 10 participants (Actual) | Interventional | 2014-10-31 | Completed |
| Clinical Trial: Intratympanic Injection of N-acetylcysteine for Protection of Cisplatin-induced Ototoxicity [NCT04226456] | Phase 4 | 19 participants (Actual) | Interventional | 2021-07-10 | Terminated(stopped due to poor recruitment) |
| Neurocircuit Strategy to Decrease Cocaine Cue Reactivity [NCT04155632] | Phase 2 | 96 participants (Anticipated) | Interventional | 2020-12-18 | Recruiting |
| Role of HIV on Glutathione Synthesis and Oxidative Stress [NCT01355198] | Phase 1 | 10 participants (Actual) | Interventional | 2010-08-31 | Completed |
| Effect of N-acetylcysteine on Hydrogen Sulfide in Chronic Kidney Disease [NCT01232257] | Phase 3 | 28 participants (Actual) | Interventional | 2011-07-31 | Completed |
| N-acetylcysteine to Prevent Renal Failure in Patients With Chronic Kidney Disease Undergoing Coronary Artery Bypass Surgery [NCT01359722] | | 50 participants (Anticipated) | Interventional | 2010-03-31 | Recruiting |
| Pilot Study to Evaluate Inhaled N-Acetylcysteine in Pulmonary Fibrosis [NCT03720483] | Phase 1/Phase 2 | 0 participants (Actual) | Interventional | 2022-01-31 | Withdrawn(stopped due to The study encountered challenges during startup due to the COVID-19 epidemic and was withdrawn.) |
| The Efficacy of N-acetyl-cysteine in the Treatment of Burning Mouth Syndrome [NCT05309070] | | 60 participants (Anticipated) | Interventional | 2022-05-01 | Recruiting |
| Ability of N-acetylcysteine to Prevent Deterioration in Renal Functioning in CKD Patients Undergoing Major Surgery Under General Anesthesia [NCT01251029] | Phase 1 | 0 participants | Interventional | 2011-01-31 | Not yet recruiting |
| Efficacy and Safety of Acetylcysteine for the Treatment of Acute Uncomplicated Rhinosinusitis: a Prospective, Randomized, Double-blind, Placebo-controlled Trial [NCT04123405] | Phase 3 | 944 participants (Actual) | Interventional | 2020-10-22 | Completed |
| Prevention of Contrast-induced Nephropathy in Patients With Acute Myocardial Infarction [NCT01160627] | | 720 participants (Actual) | Interventional | 2010-04-30 | Completed |
| Early N-Acetyl Cysteine Treatment for Head Trauma-induced Anosmia [NCT03680911] | Phase 3 | 7 participants (Actual) | Interventional | 2018-10-12 | Terminated(stopped due to Poor participant compliance) |
| Inflammatory Mediators in Obstructive Sleep Apnoea Syndrome; Mechanisms of Production and the Effect of Long Term Antioxidants Administration [NCT01188005] | | 30 participants (Anticipated) | Interventional | 2010-08-31 | Recruiting |
| Effect of N-acetylcysteine Versus Calcium Hydroxide Used as an Intracanal Medicament on the Intensity of Postoperative Pain, Bacterial Load Reduction and Levels of MMP -9 in Periapical Fluids in Patients With Necrotic Pulp: A Randomized Clinical Trial [NCT05666089] | Early Phase 1 | 30 participants (Anticipated) | Interventional | 2023-02-01 | Not yet recruiting |
| A Human Laboratory Study of n-Acetylcysteine for Alcohol Use Disorder [NCT03216954] | Early Phase 1 | 14 participants (Actual) | Interventional | 2017-09-15 | Completed |
| N-acetylcysteine Supplementation in Individuals With Low Glutathione Levels: the Effects on Physical Performance and Redox Homeostasis [NCT03121222] | Phase 2 | 36 participants (Actual) | Interventional | 2015-11-01 | Completed |
| A Randomized Controlled Trial of N-Acetylcysteine for Alcohol Use Disorder and Comorbid Post Traumatic Stress Disorder [NCT02966873] | Phase 2 | 182 participants (Actual) | Interventional | 2016-10-01 | Completed |
| Double-Blind, Placebo-Controlled Trial of N-acetylcysteine for the Treatment of Pediatric Trichotillomania [NCT00993265] | Phase 2 | 39 participants (Actual) | Interventional | 2009-10-31 | Completed |
| Cardiac Arrhythmia Catheter Ablation Procedures Guided by x-Ray Imaging: N-Acetylcysteine Protection Against Radiation Induced Cellular damagE (CARAPACE Study) [NCT04154982] | Phase 2 | 550 participants (Anticipated) | Interventional | 2020-09-02 | Recruiting |
| An Open-Label Study of N-Acetyl Cysteine in Autism [NCT00676195] | Phase 2 | 24 participants (Actual) | Interventional | 2008-06-30 | Completed |
| N-acetyl Cysteine in Post-reperfusion Pulmonary Injury in Patients With Chronic Thromboembolic Pulmonary Hypertension Undergoing Pulmonary Balloon Angioplasty and Pulmonary Endarterectomy. [NCT04081012] | | 34 participants (Anticipated) | Interventional | 2019-05-21 | Recruiting |
| Effect of Oral N-Acetyl Cysteine on Pregnancy Outcome After Cervical Cerclage: a Randomized Controlled Trial [NCT00787813] | | 100 participants (Anticipated) | Interventional | 2008-06-30 | Completed |
| N-acetylcysteine in the Treatment of Depressive Symptoms in Youth at High-risk for Bipolar Disorder: a Functional Connectivity Study [NCT02865629] | | 22 participants (Anticipated) | Interventional | 2016-08-31 | Recruiting |
| Biomarker Validation for Niemann-Pick Disease, Type C: Safety and Efficacy of N-Acetyl Cysteine [NCT00975689] | Phase 1/Phase 2 | 35 participants (Actual) | Interventional | 2009-08-31 | Completed |
| Efficacy of N-Acetylcysteine in Prevention of Contrast-Induced Nephropathy After Cardiac Catheterization in Patients With Diabetes Mellitus and Chronic Kidney Disease: A Randomized Clinical Trial [NCT00808795] | Phase 3 | 90 participants (Actual) | Interventional | 2006-04-30 | Completed |
| A Open Label, Multi-Dose, Multi-Period Exploratory Clinical Trial to Test Immune Diversity Response to Oral Dosing of Approved Nutritional Health Products at Approved Doses to Healthy Volunteers [NCT05242718] | | 32 participants (Actual) | Interventional | 2021-01-10 | Completed |
| N-acetylcysteine for Attenuation of COVID Symptomatology [NCT05074121] | Phase 2 | 200 participants (Anticipated) | Interventional | 2024-03-31 | Not yet recruiting |
| Treatment of Acute Severe Alcoholic Hepatitis With Corticoids Plus N Acetyl Cysteine Versus Corticoids Alone: a French Multicentre Randomized Controlled Study. [NCT00863785] | Phase 3 | 174 participants (Actual) | Interventional | 2004-04-30 | Completed |
| Prospective, Randomized, Double-blinded, Placebo-controlled Study of N-acetylcysteine Plus Deferoxamine for Patients With Hypotension as Prophylaxis for Acute Renal Failure [NCT00870883] | Phase 2 | 81 participants (Actual) | Interventional | 2009-03-31 | Completed |
| Randomized, Placebo-controlled, Double-blind, Dose Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetic Profile of HPN-07 and HPN-07 Plus NAC in Single Doses in Male and Female Subjects [NCT02259595] | Phase 1 | 32 participants (Actual) | Interventional | 2014-10-31 | Completed |
| N-Acetylcysteine Versus L-carnitine in Clomiphene Citrate Resistant Pcos Women. a Randomized Controlled Trial [NCT03164421] | Phase 2 | 164 participants (Actual) | Interventional | 2017-01-31 | Completed |
| Effects of GSH and N-Acetylcysteine on Inflammatory Markers Among Adults With CVD Risk [NCT01550432] | | 78 participants (Actual) | Interventional | 2011-06-30 | Completed |
| Pharmacological Treatment of a Rare Genetic Disease: Pilot Trial Phase II-III With N-acetylcysteine in Myopathy Associated SEPN1-RM (Selenoprotein N-related Myopathy) [NCT02505087] | Phase 2/Phase 3 | 7 participants (Actual) | Interventional | 2015-09-30 | Terminated |
| Phytoestrogen, NO Donors, N-acetyl Cysteine Add Therapy to Clomiphene [NCT02493933] | Phase 1 | 240 participants (Anticipated) | Interventional | 2015-07-31 | Not yet recruiting |
| Pilot Study of Topical Intranasal N-acetyl Cysteine Administration for the Treatment of Anosmia [NCT02481609] | Early Phase 1 | 29 participants (Actual) | Interventional | 2014-07-31 | Completed |
| Clinical Study Evaluating the Safety and Efficacy of N-acetyl Cysteine in Children With Drug-Resistant Epilepsy [NCT05485558] | Phase 2 | 45 participants (Anticipated) | Interventional | 2022-09-15 | Recruiting |
| Effects of N-Acetyl-Cysteine on Oxidative Stress Biomarkers in Bipolar Patients With and Without Tobacco Use Disorder [NCT02252341] | Phase 4 | 130 participants (Anticipated) | Interventional | 2014-09-30 | Enrolling by invitation |
| [NCT02124941] | Phase 1 | 6 participants (Actual) | Interventional | 2014-02-28 | Completed |
| The Impact of N-Acetylcysteine on Volumetric Retention of Autologous Fat Graft for Breast Asymmetry Correction [NCT03197103] | Phase 4 | 15 participants (Actual) | Interventional | 2017-07-04 | Active, not recruiting |
| Marijuana Cue-Reactivity & Seeking Behavior in Regular Cannabis Users: A Pilot Test of Glutamatergic Modulation [NCT03154580] | Phase 1 | 21 participants (Actual) | Interventional | 2017-05-01 | Active, not recruiting |
| The Role of Glutathione Deficiency and MSIDS Variables in Long COVID-19 [NCT05371288] | Early Phase 1 | 50 participants (Anticipated) | Interventional | 2024-06-30 | Not yet recruiting |
| Effects of Oral N- Acetylcysteine on Macular Function in Retinitis Pigmentosa; a Phase 2 Randomized Controlled Trial [NCT04864496] | Phase 2 | 30 participants (Anticipated) | Interventional | 2021-04-17 | Active, not recruiting |
| Effects of Antiplatelet and Antioxidant Agents on Drusen Progression: A Pilot, Prospective Cohort Study [NCT06165068] | Phase 3 | 174 participants (Anticipated) | Interventional | 2023-12-31 | Recruiting |
| The Effects of Kynurenine Aminotransferase Inhibition in People With Schizophrenia [NCT04013555] | Phase 1/Phase 2 | 75 participants (Anticipated) | Interventional | 2020-01-20 | Recruiting |
| Clinical and Biochemical Study of the Effects of Rosuvastatin, Vitamin E, and N-Acetyl Cysteine on Patients With Non-alcoholic Steatohepatitis: a Randomized Controlled Trial [NCT06105060] | Early Phase 1 | 160 participants (Anticipated) | Interventional | 2023-12-17 | Not yet recruiting |
| The Effect of Acetylcysteine and Ascorbic Acid on the Prevention of Radiographic-contrast-agent Induced Reduction in Renal Function in ICU Patients. [NCT01017796] | Early Phase 1 | 100 participants (Anticipated) | Interventional | 2009-01-31 | Active, not recruiting |
| Investigation of the Efficacy of N-acetylcysteine (NAC) to Protect Against Hepato-renal Ischemia-reperfusion Injury in Patients Undergoing Orthotopic Liver Transplantation [NCT00736541] | | 100 participants (Actual) | Interventional | 2004-07-31 | Completed |
| A Double-Blind Randomized Controlled Trial of N-acetylcysteine (NAC) for the Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease [NCT05706402] | Phase 3 | 80 participants (Anticipated) | Interventional | 2023-09-18 | Recruiting |
| [NCT01015209] | Phase 1 | 30 participants (Actual) | Interventional | 2010-09-30 | Completed |
| N-Acetylcysteine for the Treatment of Alcoholic Hepatitis: a Belgian Multicenter Randomised Trial [NCT00962442] | Phase 3 | 44 participants (Actual) | Interventional | 2000-09-30 | Completed |
| Effect of N-acetyl Cysteine on Markers of Oxidative Stress and Insulin Resistance in Patients With Non-alcoholic Fatty Liver Disease [NCT05589584] | Phase 3 | 60 participants (Anticipated) | Interventional | 2022-10-31 | Recruiting |
| Preventive Administration of N-acetyl-cysteine (NAC) in Organ Donor: Effects on Kidney Graft Function [NCT00998972] | Phase 3 | 236 participants (Actual) | Interventional | 2006-09-30 | Completed |
| The Use of Anti-oxidants to Reduce Sequela of Mild TBI (mTBI) After Blast Exposure [NCT00822263] | | 150 participants (Anticipated) | Interventional | 2008-11-30 | Completed |
| Phase II Study of N-acetylcysteine in Severe or Critically Ill Patients With Refractory COVID-19 Infection [NCT04374461] | Phase 2 | 48 participants (Actual) | Interventional | 2020-05-01 | Active, not recruiting |
| Risk Stratification-directed N-acetyl-L-cysteine for Prevention of Poor Hematopoietic Reconstitution After Unmanipulated Haploidentical Stem Cell Transplantation--an Open-label, Randomized, Controlled, Clinical Trial [NCT03967665] | Phase 3 | 130 participants (Actual) | Interventional | 2018-10-01 | Active, not recruiting |
| ROS Signaling in Endothelial Function [NCT01037465] | | 72 participants (Actual) | Interventional | 2008-09-30 | Completed |
| Evaluation of the Efficacy and Safety of Rifaximin in Combination With N-acetylcysteine (NAC) in Adult Patients With Irritable Bowel Syndrome With Diarrhea [NCT04557215] | Phase 1/Phase 2 | 45 participants (Actual) | Interventional | 2020-11-13 | Completed |
| A Pilot Study Investigating the Efficacy of Minocycline and N-Acetyl Cysteine for Bipolar Depression [NCT02719392] | Phase 4 | 40 participants (Anticipated) | Interventional | 2017-08-09 | Suspended(stopped due to Due to limited study staff and the COVID-19 pandemic, enrollment has been paused as staff hours for this project have been reduced and reallocated to other projects.) |
| Effect of N-Acetylcysteine on Autologous Fat Graft Survival [NCT02788292] | Phase 4 | 14 participants (Anticipated) | Interventional | 2016-07-31 | Not yet recruiting |
| N-acetyl-cysteine in Clomiphene Citrate Resistant Polycystic Ovary Syndrome After Laparoscopic Ovarian Drilling: A Randomized Controlled Trial [NCT02775734] | Phase 2/Phase 3 | 144 participants (Actual) | Interventional | 2016-05-31 | Completed |
| Application of LiveSpo Navax® in the Treatment Support of Acute Rhinosinusitis and Acute Otitis Media [NCT05804123] | | 120 participants (Anticipated) | Interventional | 2021-10-28 | Recruiting |
| The Effect of Substrate Supply on Modulating Plasma GSH Levels in Treated HIV+ Patients [NCT00910442] | Phase 2 | 32 participants (Actual) | Interventional | 2002-02-28 | Completed |
| A Prospective Study on Incidence and Prevention of Contrast-induced Nephropathy in Croatia With the Use of Standard Laboratory Measures and Novel Biomarkers [NCT02761577] | Phase 4 | 90 participants (Actual) | Interventional | 2012-06-30 | Completed |
| Effect on Migraine Frequency of Combined Anti-oxidant Therapy: N-acetylcysteine, Vitamin E and Vitamin C (NEC): The MIGRANT Study [NCT02629536] | Phase 3 | 90 participants (Anticipated) | Interventional | 2016-03-31 | Not yet recruiting |
| Potentially Nephroprotective Effects of Carnitine and Phosphodiesterase Type 5 (PDE5) Inhibitor Agent Against Contrast Media-induced Nephropathy (CMN): A Double Blind Randomized Study [NCT01564303] | | 80 participants (Anticipated) | Interventional | 2012-05-31 | Not yet recruiting |
| [NCT01033149] | Phase 3 | 11 participants (Actual) | Interventional | 2009-12-31 | Terminated |
| A Phase I Study of Repeated Neural Stem Cell Based Virotherapy in Combination With N-Acetylcysteine Amid (NACA) and Standard Radiation and Chemotherapy for Newly Diagnosed High Grade Glioma [NCT06169280] | Phase 1 | 20 participants (Anticipated) | Interventional | 2024-01-02 | Not yet recruiting |
| NAC Attack, A Phase III, Multicenter, Randomized, Parallel, Double Masked, Placebo-Controlled Study Evaluating the Efficacy and Safety of Oral N-Acetylcysteine in Patients With Retinitis Pigmentosa [NCT05537220] | Phase 3 | 438 participants (Anticipated) | Interventional | 2023-10-11 | Recruiting |
| Role of Oxidative Stress and Inflammation in Type 1 Gaucher Disease (GD1): Potential Use of Antioxidant/Anti-inflammatory Medications [NCT02583672] | Phase 2 | 50 participants (Anticipated) | Interventional | 2015-09-30 | Recruiting |
| Use of N-Acetylcysteine (NAC) in the Treatment of Repetitive Behaviors (RB) and Self-Injurious Behaviors (SIB) in Cornelia de Lange Syndrome: A Randomized Double-Blind Placebo-Controlled Pilot Study [NCT04381897] | Phase 2 | 10 participants (Anticipated) | Interventional | 2024-04-01 | Not yet recruiting |
| A Phase I Double-blind, Randomized, Comparator-controlled Study of the Safety and Tolerability of N-acetylcysteine Plus Mesalamine Enema in Subjects With Left-sided Ulcerative Colitis [NCT01020708] | Phase 1 | 9 participants (Anticipated) | Interventional | 2009-11-30 | Completed |
| A Pilot Study of Oral N-Acetylcysteine in Children With Autism Spectrum Disorders [NCT00453180] | Phase 2 | 31 participants (Actual) | Interventional | 2007-03-31 | Completed |
| A Double-Blind Study of N-Acetylcysteine Augmentation in Serotonin Reuptake Inhibitor-Refractory Obsessive-Compulsive Disorder and Depression [NCT00539513] | Phase 2 | 10 participants (Actual) | Interventional | 2006-06-30 | Terminated(stopped due to Researchers terminated study due to limited enrollment.) |
| Efficacy of N-acetylcysteine With or Without Steroids in Drug Induced Liver Injury: A Prospective Randomized Controlled Trial [NCT02686385] | | 4 participants (Actual) | Interventional | 2016-03-01 | Terminated(stopped due to Steroids were given for 2 patients who had biopsy proven Drug induced Liver Injury and both have them developed sepsis.) |
| A Double-Blind, Placebo-Controlled Study of N-Acetyl Cysteine in Pathologic Skin Picking [NCT01063348] | Phase 2 | 66 participants (Actual) | Interventional | 2012-09-30 | Completed |
| Pre-medication With N-acetylcysteine and Simethicone to Improve Mucosal Visibility During Gastroduodenoscopy: A Double Blind, Randomized Controlled Trial. [NCT05951712] | | 800 participants (Actual) | Interventional | 2022-06-16 | Completed |
| Experimentally Evaluating the Hypothesized Mechanism of Action of N-acetylcysteine for Bipolar Disorder [NCT05340504] | Phase 2 | 12 participants (Actual) | Interventional | 2022-05-13 | Completed |
| N-Acetylcysteine and Milk Thistle for Treatment of Diabetic Nephropathy. [NCT00915200] | Phase 2 | 114 participants (Actual) | Interventional | 2009-10-31 | Completed |
| Functional Consequences and Therapeutic Intervention in Hampered Production of Cysteine, Glutathione and Taurine in Classical Homocystinuria [NCT04015557] | Phase 1/Phase 2 | 10 participants (Anticipated) | Interventional | 2022-02-11 | Suspended(stopped due to Study was interrupted due to COVID-19 pandemic) |
| A Multi-Center, Phase IIB, Randomized, Placebo-controlled, Double-Blind Study Of The Effects Of N-Acetylcysteine On Redox Changes and Lung Inflammation In Cystic Fibrosis Patients [NCT00809094] | Phase 2 | 70 participants (Actual) | Interventional | 2008-11-30 | Completed |
| [NCT00716001] | Phase 4 | 0 participants | Interventional | 2008-07-31 | Not yet recruiting |
| A Randomized Controlled Trial of Oral N-acetylcysteine for Smoking Reduction: a Pilot Study [NCT00751257] | Phase 2 | 33 participants (Actual) | Interventional | 2006-12-31 | Completed |
| Randomized Study on N-acetylcysteine Treatment and Outcomes in Patients With Advanced Atherosclerotic Heart Diseases and Diabetes Mellitus (RENEWAL) [NCT05908513] | Phase 1 | 0 participants (Actual) | Interventional | 2021-10-15 | Withdrawn(stopped due to Lack of available resources needed to conduct study.) |
| The Efficiency and Safety of N-acetylcysteine for Prevention of Thrombotic Events After Allogenic Hematopoietic Stem Cell Transplantation [NCT05907486] | Phase 3 | 260 participants (Anticipated) | Interventional | 2023-08-01 | Not yet recruiting |
| Evaluation of the Effect of Acetylcysteine and Vitamin E on Psoriasis Vulgaris Patients During The Active Phase [NCT05906498] | Phase 3 | 60 participants (Anticipated) | Interventional | 2022-12-01 | Recruiting |
| Effect of N-Acetylcysteine on Neutrophil Lymphocyte Ratio And Length of Stay In COVID-19 Patients [NCT05658549] | Phase 1/Phase 2 | 120 participants (Actual) | Interventional | 2021-05-01 | Completed |
| A Randomized, Double Blind, Placebo Controlled Trial of Intravenous N-acetylcysteine and Oseltamivir Versus Intravenous 5% Dextrose and Oseltamivir in Adults Hospitalized With Influenza Complicated by Lower Respiratory Tract Infection. [NCT03900988] | Phase 3 | 160 participants (Anticipated) | Interventional | 2023-05-08 | Recruiting |
| A Pragmatic Randomized Clinical Trial Evaluating the Effect of Acetylcysteine for Contrast-induced Nephropathy [NCT00736866] | Phase 3 | 2,300 participants (Anticipated) | Interventional | 2008-08-31 | Completed |
| Prednisone, Azathioprine, and N-acetylcysteine: A Study That Evaluates Response in IPF [NCT00650091] | Phase 3 | 264 participants (Actual) | Interventional | 2009-10-31 | Completed |
| Double-blind , Randomized, Placebo Controlled Study of N-Acetyl Cysteine in Autism. [NCT00627705] | Phase 2 | 43 participants (Actual) | Interventional | 2008-02-29 | Completed |
| Evaluation of Aerosolized Drugs Deposition Delivered Through a Mechanical Ventilator [NCT02818270] | | 30 participants (Actual) | Interventional | 2016-06-30 | Completed |
| Treatment of Wolfram Syndrome Type 2 With the Chelator Deferiprone, and Incretin Based Therapy [NCT02882477] | Phase 2/Phase 3 | 20 participants (Anticipated) | Interventional | 2016-12-31 | Not yet recruiting |
| N-Acetylcysteine in Critically Ill Patients Undergoing Contrast Enhanced Computed Tomography: A Randomized Trial [NCT00830193] | Phase 2/Phase 3 | 45 participants (Actual) | Interventional | 2002-08-31 | Completed |
| The Effect of Redox Potential on the Regulation of Satellite Cells and Skeletal Muscle Healing Following Exercise-Induced Muscle Damage [NCT03711838] | | 45 participants (Actual) | Interventional | 2019-07-22 | Completed |
| Investigation of the Effect of N Acetylcysteine Against Anti-Tuberculosis Drugs Induced Liver Toxicity [NCT00564642] | | 60 participants (Actual) | Interventional | 2007-11-30 | Completed |
| N-acetylcysteine Plus Transcutaneous Vagus Nerve Stimulation in Infants of Diabetic Mothers Who Fail Oral Feeding [NCT04632069] | Early Phase 1 | 10 participants (Actual) | Interventional | 2021-08-12 | Active, not recruiting |
| Phase 3 Study of N-acetyl Cysteine as an Antioxidant and Glutathione Synthesis Inducer on Biomarkers of Delayed Renal Graft Function Including NGAL and IL-18 [NCT01403506] | Phase 3 | 60 participants (Anticipated) | Interventional | 2011-04-30 | Recruiting |
| Protective Effect of N-acetylcysteine on Early Outcomes of Deceased Renal Transplant [NCT00994305] | | 74 participants (Anticipated) | Interventional | 2005-04-30 | Active, not recruiting |
| Double Blind, Randomized, Placebo-controlled, Two-way Crossover, Pilot Study to Assess the Effect of High Dose N-acetylcysteine on Small Airways and on Inflammation and Oxidative Stress in COPD Patients. [NCT00969904] | Phase 4 | 12 participants (Actual) | Interventional | 2009-03-31 | Completed |
| Postoperative Nasal Irrigation Using Mucolytic Agents in Patients Undergoing Endoscopic Sinus Surgery [NCT01582555] | | 44 participants (Anticipated) | Interventional | 2012-06-30 | Not yet recruiting |
| A Double-Blind, Placebo-Controlled Study of N-Acetyl Cysteine in Trichotillomania [NCT00354770] | Phase 2 | 50 participants (Actual) | Interventional | 2006-07-31 | Completed |
| The Effect of N-acetylcysteine on Oxidative Stress Status and Iron Overload in Thalassemia Major [NCT04260516] | Phase 1 | 100 participants (Actual) | Interventional | 2019-06-03 | Completed |
| A Double-Blind, Placebo-controlled Pilot Study of NAC Addition to Dialectical Behavioral Therapy for the Treatment of Self-Injurious Behavior Associated With Borderline Personality Disorder [NCT00539188] | Phase 2 | 6 participants (Actual) | Interventional | 2007-09-30 | Terminated(stopped due to Study terminated due to poor subject compliance.) |
| How do Glutathione Levels Affect Compulsivity? A Double-blind, Placebo-controlled Study [NCT02794389] | | 23 participants (Actual) | Interventional | 2016-03-31 | Completed |
| Anti-microbial Role of Non-antibiotic Agents Against Cutibacterium Acnes in Patients With Acne Vulgaris [NCT06179056] | | 24 participants (Actual) | Observational | 2023-03-01 | Completed |
| The Effect of Inhaled N-Acetylcysteine Compared to Normal Saline on Sputum Rheology and Lung Function. [NCT00996424] | Phase 4 | 19 participants (Actual) | Interventional | 2010-01-31 | Terminated(stopped due to Insufficient recruitment.) |
| N-acetyl Cysteine Plus Clomiphene Citrate Versus Metformin and Clomiphene Citrate in Treatment of Clomiphene-resistant Polycystic Ovary Syndrome [NCT01008046] | | 192 participants (Actual) | Interventional | 2007-04-30 | Completed |
| The Prevalence of Insulin Resistance and the Potential Modulation of Insulin Resistance by N-acetylcysteine (NAC) in Patients Chronically Infected by the Hepatitis C Virus [NCT00614757] | | 121 participants (Actual) | Interventional | 2005-05-31 | Suspended |
| Effectiveness of N-acetylcysteine on Preservation Solution During Liver Transplantation [NCT01866644] | Phase 3 | 214 participants (Actual) | Interventional | 2011-09-30 | Completed |
| RCT for the Treatment of Hemodialysis Catheter-Related Bacteremia [NCT02040818] | Phase 2/Phase 3 | 0 participants (Actual) | Interventional | 2013-11-30 | Withdrawn(stopped due to no enrollment) |
| Modulation of Lung Injury Complicating Lung Resection [NCT00655928] | Phase 2 | 52 participants (Actual) | Interventional | 2007-08-31 | Completed |
| The Effect of Supplemental Adjuvants for Intracellular Nutrition and Treatment on Diabetic Macular Edema and Neovascular Age-Related Macular Degeneration [NCT00893724] | | 60 participants (Anticipated) | Interventional | 2009-06-30 | Active, not recruiting |
| A Randomised Trial to Assess the Effectiveness of Pre-treatment With Ondansetron at Reducing Nausea and Vomiting in Patients Treated With Either the Conventional Regimen or a Modified Regimen of Acetylcysteine for Paracetamol Poisoning [NCT01050270] | Phase 4 | 222 participants (Actual) | Interventional | 2010-09-30 | Completed |
| A Multi-center Study of the Safety and Efficacy of N-acetylcysteine in the Treatment of Acute Liver Failure in Pediatric Patients Not Caused by Acetaminophen. [NCT00248625] | Phase 3 | 184 participants (Actual) | Interventional | 2000-01-31 | Completed |
| Targeting the Neurobiology of Restricted and Repetitive Behaviors in Children With Autism Using N-acetylcysteine: A Randomized, Controlled Trial [NCT05664789] | Phase 2/Phase 3 | 48 participants (Anticipated) | Interventional | 2023-04-26 | Recruiting |
| Targeting the Neurobiology of Restricted and Repetitive Behaviors in Children With Autism Using N-acetylcysteine: an Open Label Extension [NCT05494398] | Phase 2/Phase 3 | 48 participants (Anticipated) | Interventional | 2022-11-15 | Enrolling by invitation |
| Targeting the Neurobiology of Restricted and Repetitive Behaviors in Children With Autism Using N-acetylcysteine: a Single-dose Challenge Study [NCT04278898] | Phase 2 | 24 participants (Anticipated) | Interventional | 2021-02-12 | Recruiting |
| Imaging Framework for Testing GABAergic/Glutamatergic Drugs in Bipolar Alcoholics [NCT03220776] | Phase 2 | 54 participants (Actual) | Interventional | 2017-08-07 | Completed |
| [NCT01021163] | Phase 4 | 48 participants (Actual) | Interventional | | Completed |
| Pilot Study of a Multi-Drug Regimen for Severe Pulmonary Fibrosis in Hermansky-Pudlak Syndrome [NCT00467831] | Phase 1/Phase 2 | 3 participants (Actual) | Interventional | 2007-04-30 | Terminated(stopped due to insufficient enrollment) |
| Pilot Study of Anti-oxidant Supplementation With N-Acetyl Cysteine in Stage 0/I Breast Cancer [NCT01878695] | Phase 1 | 13 participants (Actual) | Interventional | 2012-07-26 | Completed |
| Dietary Supplement N-acetylcysteine (NAC) as a Novel Complementary Medicine to Improve Cognitive Disfunction in Schizophrenia [NCT01885338] | Phase 1 | 26 participants (Actual) | Interventional | 2013-06-30 | Completed |
| A Phase 2 Study of the Efficacy of Antioxidant Therapy Compared With Enalapril in Slowing the Progression of Sickle Nephropathy in Children [NCT01891292] | | 30 participants (Anticipated) | Interventional | 2013-07-31 | Not yet recruiting |
| The Role of S-nitrosohemoglobin in Regulating Systemic Blood Flow Under Hypoxic and Normoxic Conditions [NCT01905696] | Early Phase 1 | 10 participants (Actual) | Interventional | 2013-03-31 | Terminated(stopped due to Lack of funding) |
| Acute Renal Failure Post Liver Transplantation: The Role of Cytokines and Oxidative Stress [NCT01907061] | | 30 participants (Actual) | Interventional | 2007-07-31 | Completed |
| A Pilot, Multicenter, Open-label, One-group Study to Explore the Efficacy, Tolerability and Safety of the Combination of Glatiramer Acetate (GA) and N-Acetylcysteine (NAC) in Subjects With Relapsing Remitting Multiple Sclerosis (RR-MS) [NCT00203099] | Phase 2 | 18 participants (Actual) | Interventional | 2004-12-31 | Completed |
| Phase I Dose Escalation Study of N-Acetylcysteine Administered in Conjunction With Carboplatin, Cyclophosphamide, and Etoposide Phosphate BBBD, in Children With Malignant Brain Tumors [NCT00238173] | Phase 1 | 2 participants (Actual) | Interventional | 2004-12-31 | Terminated(stopped due to OHSU IRB closed study to further enrollment 2/17/2006) |
| Study of N-Acetylcysteine for Treatment of Overt Diabetic Nephropathy [NCT00556465] | Phase 2/Phase 3 | 60 participants (Actual) | Interventional | 2007-01-31 | Completed |
| N-Acetylcysteine and Vitamin D in Infants With Hypoxic Ischemic Encephalopathy Treated With Hypothermia [NCT04643821] | Early Phase 1 | 30 participants (Actual) | Interventional | 2015-01-01 | Completed |
| Prevention of Cartilage Cell Death Following a Pilon Fracture With Intra-articular Injection of N-Acetylcysteine (Pilon NAC) [NCT03652753] | Phase 4 | 30 participants (Anticipated) | Interventional | 2019-01-01 | Recruiting |
| N-Acetyl Cysteine Plus Behavioral Therapy for Nicotine Dependent Pathological Gamblers [NCT00967005] | Phase 2 | 28 participants (Actual) | Interventional | 2009-09-30 | Completed |
| A Pilot Trial of Acute N-Acetylcysteine Effects on Working Memory and Other Cognitive Functions in Schizophrenia [NCT01232790] | | 28 participants (Actual) | Interventional | 2010-02-28 | Completed |
| TO COMPARE THE EFFICACY OF N -ACETYLCYSTEINE AND STANDARD THERAPY VERSUS STANDARD THERAPY IN THE PREVENTION OF ISCHEMIC HEPATITIS AND SURVIVAL POST UPPER GI BLEED [NCT02015403] | | 220 participants (Actual) | Interventional | 2013-12-31 | Completed |
| Oral N-Acetyl Cysteine Can Prevent Preterm Labour in Multiparae With Previous Preterm Labour [NCT00568113] | Phase 4 | 120 participants (Actual) | Interventional | 2007-07-31 | Completed |
| Effects of Arginine and N-Acetylcysteine Administration on Nitric Oxide Production and Arterial Blood Pressure in Hypertensive Diabetic Patients. [NCT00569465] | Phase 4 | 24 participants (Actual) | Interventional | 2005-01-31 | Terminated(stopped due to End of the study) |
| The Effect of N-Acetylcysteine on Proteinuria and Markers of Tubular Injury in Non-Diabetic Patientswith Chronic Kidney Disease-Placebo Controlled, Randomized,Open, Cross-Over Study [NCT00572663] | | 0 participants | Interventional | 2005-01-31 | Completed |
| Open Clinical Trial of the Use of Antioxidants and Pentoxifylline as Adjuvant Therapy to Standard Therapy in Patients With and Without Septic Shock Secondary to COVID-19 Severe Pneumonia [NCT04570254] | | 110 participants (Actual) | Interventional | 2020-08-19 | Completed |
| A Prospective, Randomized Trial Comparing Oral N-Acetylcysteine and Intravenous Sodium Bicarbonate for the Prevention of Contrast-Induced Nephropathy in High-Risk Patients Undergoing Cardiac Catheterization [NCT00579995] | | 41 participants (Actual) | Interventional | 2005-05-01 | Terminated(stopped due to Technical measurement problems led to unreliable or uninterpretable data.) |
| Possible Ameliorating Effect of N- Acetylcysteine on Type-II Diabetes Induced Nephropathy [NCT04531163] | Phase 2/Phase 3 | 60 participants (Actual) | Interventional | 2019-10-01 | Active, not recruiting |
| Double-Blind, Placebo-Controlled Trial of N-acetylcysteine (NAC) for the Treatment of Pediatric Obsessive-Compulsive Disorder [NCT01172275] | Phase 2 | 11 participants (Actual) | Interventional | 2012-07-31 | Completed |
| The Use of Oral N-Acetyl Cysteine for the Treatment of Chronic Sinonasal Symptoms: A Randomized, Double-Blind, Placebo-Controlled Trial [NCT00866866] | Phase 4 | 60 participants (Anticipated) | Interventional | 2009-03-31 | Recruiting |
| Open Label, Randomized, Two-Arm, Single-Dose, Two-Period, Crossover Study to Determine the Relative Bioavailability of AR10 (Acetylcysteine Effervescent Tablets) Compared to Reference Product in Healthy, Adult Subjects, Fasting [NCT02723669] | Phase 1 | 30 participants (Actual) | Interventional | 2014-04-30 | Completed |
| Evaluation of the Effect of Acetazolamide, Mannitol and N-acetylcysteine on Cisplatin-Induced Nephrotoxicity [NCT02760901] | Phase 2 | 52 participants (Actual) | Interventional | 2013-11-30 | Completed |
| High-Volume Plasma Exchange Versus Standard Medical Treatment in Patients With Acute Liver Failure-A Prospective Randomized Pilot Trial [NCT02718079] | | 40 participants (Actual) | Interventional | 2016-12-30 | Completed |
| Effect of N-Acetyl Cysteine (NAC) on the Oral Microbiome and on the Degree of Mucositis Developed in Response to Concurrent Chemotherapy and Radiotherapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck [NCT03982537] | Phase 2 | 0 participants (Actual) | Interventional | 2020-06-18 | Withdrawn(stopped due to Concept is withdrawn and a different concept will be submitted the near future.) |
| Correction of Neonatal Glutathione by N-acetylcysteine in Pregnant Women at Risk of Premature Birth [NCT03596125] | Phase 2/Phase 3 | 39 participants (Actual) | Interventional | 2018-11-05 | Terminated(stopped due to difficulty of recruitment) |
| Prospective Analysis of the Use of N-Acetylcysteine and Vitamins in the Treatment of TBI in Geriatric Patients [NCT04291066] | Phase 2 | 92 participants (Actual) | Interventional | 2019-09-01 | Completed |
| A Randomized, Open-Label, Two-Period, Crossover Bioequivalence Study in Healthy Adult Subjects After Single Oral Dosing of a NCH-GSK Acetylcysteine 2% Oral Solution Versus a Reference Fluimucil® Acetylcysteine 2% Oral Solution [NCT02688361] | Phase 1 | 46 participants (Actual) | Interventional | 2016-02-22 | Completed |
| A Multi-center, Double-blind, Randomized, Controlled Study to Determine the Efficacy and Safety of a New Formulation of Acetylcysteine Injection [NCT01118663] | Phase 3 | 17 participants (Actual) | Interventional | 2010-09-30 | Terminated |
| Idiopathic Pulmonary Fibrosis International Group Exploring NAC I Annual Study of the Effects of High-dose N-acetylcysteine (NAC) in Idiopathic Pulmonary Fibrosis (IPF) [NCT00639496] | Phase 3 | 184 participants (Actual) | Interventional | 2000-03-31 | Completed |
| Double-Blind, Placebo-Controlled Trial of N-acetylcysteine (NAC) for the Treatment of Children With Tourette Syndrome [NCT01172288] | Phase 2 | 31 participants (Actual) | Interventional | 2010-07-31 | Completed |
| A Multiple Ascending Phase 1 Dose Study of N-acetylcysteine in the Treatment of Patients With the m.3243A>G Mutation and Low Brain Glutathione Levels [NCT05241262] | Phase 1 | 18 participants (Anticipated) | Interventional | 2023-04-30 | Recruiting |
| Prospective Treatment Efficacy in IPF Using Genotype for Nac Selection (PRECISIONS) Trial [NCT04300920] | Phase 3 | 200 participants (Anticipated) | Interventional | 2020-12-17 | Recruiting |
| N-Acetyl Cysteine Helps Pulp Stem Cells Differentiate During Endodontic Revascularization [NCT03451435] | Early Phase 1 | 14 participants (Anticipated) | Interventional | 2018-06-15 | Recruiting |
| Phase I Dose-Escalating and Phase II Dose-Expansion Study of N-Acetyl-Cysteine (NAC) Administration to Ovarian Cancer Patients Receiving Platinum-Based Therapy (PBT) for the Mitigation of Chemotherapy-Related Cognitive Impairment (CRCI) [NCT04520139] | Phase 1/Phase 2 | 102 participants (Anticipated) | Interventional | 2023-12-31 | Not yet recruiting |
| Effect of N-acetylcysteine on Prevention of Acute Kidney Injury in High Risk Patients Undergoing Off-pump Coronary Artery Bypass Graft [NCT01394419] | Phase 4 | 115 participants (Actual) | Interventional | 2010-09-30 | Completed |
| An Open-Label Clinical Trial Conducted Via Telepsychiatry of Complementary and Alternative Treatments (Omega-3 Fatty Acids and Inositol vs. N-acetylcysteine) for the Management of Emotional Dysregulation in Youth With Non-verbal Learning Disability (NVLD) [NCT03757585] | Phase 4 | 60 participants (Anticipated) | Interventional | 2019-05-20 | Recruiting |
| N-acetyl Cysteine: the Effectiveness and Safety in a Cohort of Pediatric Patients With Chronic Kidney Disease [NCT04916080] | Phase 2 | 50 participants (Actual) | Interventional | 2021-11-01 | Completed |
| Prospective, Randomized Study Using N-Acetylcysteine as Prophylaxis of Sinusoidal Obstruction Syndrome in Patients Undergoing Hematopoietic Stem Cell Transplantation [NCT04712435] | Phase 2 | 80 participants (Anticipated) | Interventional | 2021-04-30 | Not yet recruiting |
| Oxidative Stress and Postoperatory Renal Function in Deceased Kidney Transplantation [NCT00851708] | | 0 participants | Interventional | | Completed |
| Dose Escalation Study Of I.V. And Intra-Aortic N-Acetylcysteine For The Prevention Of Contrast Induced Nephropathy In Patients With Stage 3 Renal Failure Undergoing Contrast Imaging Studies: A Phase I Trial [NCT00575419] | Phase 1 | 6 participants (Actual) | Interventional | 2007-11-30 | Terminated(stopped due to Low accrual) |
| Single Center Randomized Clinical Trial of the Effects of Acetylcysteine in the Prevention of Postoperative Renal Failure [NCT00211653] | Phase 1/Phase 2 | 102 participants (Actual) | Interventional | 2003-04-30 | Completed |
| The PRIME (Perioperative Renal Insufficiency Management) Study: A Randomized, Double-blinded, Placebo-controlled Trial of N-acetylcysteine for Preventing Renal Injury After Cardiac Surgery. [NCT00188630] | Phase 3 | 176 participants (Actual) | Interventional | 2003-07-31 | Completed |
| N-Acetylcysteine Protects Against Acute Renal Insult in Patients With Abnormal Renal Function Undergoing Cardiopulmonary Bypass. [NCT00190034] | Phase 4 | 60 participants (Anticipated) | Interventional | 2005-01-31 | Suspended(stopped due to opposite result) |
| Evaluation of Using Dienogest and N-Acetyl Cysteine on the Volume of Uterine Leiomyoma [NCT06115408] | Phase 2/Phase 3 | 40 participants (Anticipated) | Interventional | 2023-07-01 | Recruiting |
| A Randomized, Double-Blind, Controlled Trial of Combined Amiodarone and N-Acetylcysteine Versus Amiodarone Plus Placebo for the Prevention of Atrial Fibrillation in High Risk Patients Undergoing Thoracic Surgery [NCT02750319] | Phase 3 | 184 participants (Actual) | Interventional | 2016-04-30 | Active, not recruiting |
| N-Acetylcysteine in Patients With Sickle Cell Disease - Reducing the Incidence of Daily Life Pain [NCT01849016] | Phase 3 | 96 participants (Actual) | Interventional | 2013-04-30 | Completed |
| Utility of the Use of N-acetylcysteine Associated With Conventional Treatment in Patients With Severe Acute Alcoholic Hepatitis (Maddrey> 32) [NCT05294744] | | 390 participants (Anticipated) | Interventional | 2022-04-30 | Not yet recruiting |
| Acetylcystein Vid Stapedotomi [NCT00525551] | Phase 4 | 152 participants (Actual) | Interventional | 2007-09-30 | Completed |
| Intratympanic N-Acetylcysteine (NAC) Injections for Prevention of Cisplatin-induced Ototoxicity in Head and Neck Cancer Patients: A Multi-centre Phase II Randomized Controlled Trial. [NCT04291209] | Phase 1/Phase 2 | 80 participants (Anticipated) | Interventional | 2020-02-26 | Recruiting |
| EVALUATION OF THE USE OF N-ACETYLCYSTEINE ATTENUATING CISPLATIN-INDUCED TOXICITIES BY OXIDATIVE STRESS IN HEAD AND NECK CANCER PATIENTS [NCT02241876] | Phase 4 | 60 participants (Anticipated) | Interventional | 2014-10-31 | Not yet recruiting |
| A Clinical Trial for Adrenomyeloneuropathy (AMN): Validation of Biomarkers of Oxidative Stress, and Efficacy, Tolerance and Safety of a Mixture of the Antioxidants N-acetylcysteine, Lipoic Acid and Vitamin E [NCT01495260] | Phase 2 | 13 participants (Actual) | Interventional | 2011-09-30 | Completed |
| An Open Labelled Randomized Multi-center Study of COmbined N-acetylcysteine and Bicarbonate in PCI To Reduce Incidence of Contrast Induced Nephropathy [NCT00497328] | Phase 2/Phase 3 | 477 participants (Actual) | Interventional | 2007-08-31 | Completed |
| The Effect of Administration on N-Acetylcysteine on Serum Creatinine Levels in Patients With Chronic Kidney Disease [NCT00498342] | | 0 participants | Interventional | 2007-06-30 | Completed |
| [NCT00592618] | | 0 participants | Interventional | | Not yet recruiting |
| Use of Mucomyst (NAC) to Ameliorate Oxidant Stress in Diabetic Patients as Measurable by Surrogate Serum Markers [NCT00493727] | | 15 participants (Actual) | Interventional | 2006-09-30 | Completed |
| Defining Neurobiological Signatures for Chronic Traumatic Brain Injury Using PET-MRI Technology [NCT03241732] | | 150 participants (Anticipated) | Interventional | 2017-06-07 | Enrolling by invitation |
| Influence of N-Acetylcysteine on Morbidity, Oxygenation and Cytokine Levels in Partial or Total Esophagectomy for Cancer. A Multicenter, Prospective, Randomised Double Blind, Placebo-controlled Study [NCT00512265] | Phase 4 | 29 participants (Actual) | Interventional | 2006-01-31 | Completed |
| Evidence of a Redox-dependent Regulation of Immune Responses to Exercise-Induced Inflammation [NCT02930031] | | 10 participants (Actual) | Interventional | 2015-01-31 | Completed |
| Randomised Control Pilot Trial of n-Acetylcysteine in the Treatment of Chronic Heart Failure With Coexistent Chronic Renal Failure. [NCT00532688] | Phase 2/Phase 3 | 10 participants (Anticipated) | Interventional | 2007-09-30 | Recruiting |
| Correction of Glutathione Deficiency for Treatment of Diabetic Nephropathy [NCT01265563] | Phase 2 | 108 participants (Actual) | Interventional | 2011-01-31 | Completed |
| The Efficacy of N-acetylcysteine Versus Placebo for the Treatment of Metamphetamine Withdrawal Symptoms [NCT04405193] | Phase 2/Phase 3 | 66 participants (Actual) | Interventional | 2019-10-01 | Completed |
| Comparison of G-Series Media System With Antioxidants Versus Standard G-Series Media System [NCT02999958] | | 128 participants (Actual) | Interventional | 2016-12-31 | Completed |
| Phase 3 Study of Protective Effect of N-acetylcysteine Against From Ototoxicity [NCT01271088] | Phase 2/Phase 3 | 60 participants (Actual) | Interventional | 2010-06-30 | Completed |
| [NCT00247507] | Phase 4 | 0 participants | Interventional | 2005-09-30 | Active, not recruiting |
| Effect of Diesel Exhaust Particulate Exposures on Endothelial Function in Humans - the Role of Oxidative Stress [NCT00434005] | | 24 participants (Actual) | Interventional | 2008-07-31 | Completed |
| Effects of N-acetylcysteine on Muscle Fatigue in ESRD [NCT00440869] | Phase 1 | 30 participants (Anticipated) | Interventional | 2007-03-31 | Completed |
| N-acetylcysteine and Fenoldopam Protect the Renal Function of Patients With Chronic Renal Insufficiency Undergoing Cardiac Surgery. [NCT00122018] | Phase 2 | 80 participants | Interventional | 2002-05-31 | Completed |
| Randomized Controlled Trial Examining the Effect of N-Acetylcysteine on Serum Creatinine in Patients With Stage 3 Chronic Kidney Disease [NCT00506506] | Phase 3 | 60 participants (Actual) | Interventional | 2007-10-31 | Completed |
| [NCT00507052] | | 0 participants | Interventional | | Not yet recruiting |
| Attenuation of Myocardial Dysfunction by N-Acetylcysteine in Infants Undergoing Arterial Switch Procedure [NCT00374088] | Phase 2 | 21 participants (Actual) | Interventional | 2005-02-28 | Completed |
| Antioxidation Medication for Noise-induced Hearing Loss [NCT00552786] | Phase 2 | 53 participants (Actual) | Interventional | 2007-11-30 | Completed |
| A Controlled Trial of N-Acetylcysteine (NAC) in Cannabis Dependent Adolescents [NCT01005810] | Phase 2 | 116 participants (Actual) | Interventional | 2009-09-30 | Completed |
| N-acetyl-L-cysteine for Promoting Hematopoietic Recovery in Patients With Acute Myeloid Leukemia After Chemotherapy--a Prospective Single-arm Clinical Study [NCT06024031] | Phase 2 | 30 participants (Anticipated) | Interventional | 2023-09-01 | Not yet recruiting |
| Pilot Feasibility Study With N-acetylcystein (NAC) in Patients With HCM Caused by Sarcomere Proteins Mutations [NCT01537926] | Phase 1 | 42 participants (Actual) | Interventional | 2012-01-31 | Completed |
| A Double-blind Placebo-controlled Trial Comparing the Efficacy and Cost-effectiveness of Inhaled Fluticason Propionate Versus Oral N-acetylcysteine in the Treatment of Patients With COPD in General Practice [NCT00184977] | Phase 4 | 270 participants | Interventional | 1998-12-31 | Completed |
| Glutathione in Mild Cognitive Impairment [NCT03493178] | Early Phase 1 | 60 participants (Anticipated) | Interventional | 2018-04-14 | Recruiting |
| Mechanisms for the Effect of Acetylcysteine on Renal Function After Exposure to Radiographic Contrast Material [NCT00558142] | Phase 4 | 90 participants (Actual) | Interventional | 2008-02-29 | Completed |
| The Role of N-acetylcysteine as a Novel Adjuvant Treatment in Acute Organophosphorus.A Randomized, Clinical Trial in Poison Control Center -Ain Shams University Hospitals [NCT05927259] | Early Phase 1 | 40 participants (Actual) | Interventional | 2022-01-01 | Completed |
| The Relation Between Hyperbaric Oxygen, Oxidative Stress, NO Bioavailability and Tissue Oxygenation in Diabetic Patients Suffering From Foot Ulcers [NCT00463671] | | 50 participants | Interventional | 2003-12-31 | Completed |
| Homocystinuria: Treatment With N-Acetylcysteine [NCT00483314] | Phase 2 | 5 participants (Actual) | Interventional | 2007-11-30 | Completed |
| Acetylcysteine, Theophylline, and a Combination of Both in the Prophylaxis of Contrast-Induced Nephropathy: A Placebo Controlled Randomized Study [NCT00492518] | Phase 4 | 254 participants (Actual) | Interventional | 2002-02-28 | Completed |
| Use of Mucomyst (NAC) to Ameliorate Oxidant Stress as Measured by Surrogate Serum in Patients With Hepatitis C [NCT00493610] | | 5 participants (Anticipated) | Interventional | 2006-11-30 | Suspended(stopped due to Collaborator no longer interested, short of funds) |
| A Trial Evaluating the Impact of N-acetylcysteine on Opioid Use in Patients Undergoing a Hysterectomy Procedure [NCT06039566] | Phase 3 | 240 participants (Anticipated) | Interventional | 2023-11-30 | Recruiting |
| A Double-Blind Study of N-Acetyl Cysteine Plus Naltrexone in the Treatment of Methamphetamine Dependence [NCT00332605] | Phase 2 | 45 participants (Actual) | Interventional | 2006-06-30 | Completed |
| Serotonin Reuptake Inhibitor Augmentation With N-Acetylcysteine in Resistant Obsessive-compulsive Disorder: a Double-blind, Randomized and Controlled Study [NCT01555970] | Phase 2 | 40 participants (Actual) | Interventional | 2012-03-31 | Completed |
| Granulocyte Colony Stimulating Factor Plus N-Acetyl Cysteine In Severe Alcoholic Hepatitis [NCT02971306] | Phase 4 | 60 participants (Anticipated) | Interventional | 2014-07-31 | Recruiting |
| Effect of N-acetylcysteine in Preventing Adverse Neonatal Outcomes in Women With Intra-amniotic Infection/Inflammation [NCT00397735] | Phase 1/Phase 2 | 68 participants (Actual) | Interventional | 2006-10-01 | Completed |
| A Randomized Factorial Trial of N-Acetylcysteine and Continuous Veno-Venous Hemo(Dia)Filtration for Rhabdomyolysis [NCT00391911] | Phase 2 | 3 participants (Actual) | Interventional | 2006-11-30 | Completed |
| Improved Estimation of Glomerular Filtration Rate by Serum Cystatin C in Preventing Contrast Induced Nephropathy by N-Acetylcysteine or Zinc [NCT00399256] | | 60 participants | Interventional | 2004-03-31 | Terminated |
| N-acetylcysteine as Treatment in Cocaine Addiction [NCT00136825] | Phase 1 | 17 participants (Actual) | Interventional | 2003-03-31 | Completed |
| Adding Antioxidants Into Human Embryo Culture Media [NCT02971878] | | 128 participants (Actual) | Interventional | 2016-11-30 | Completed |
| [NCT00396396] | | 35 participants | Interventional | 2006-10-31 | Recruiting |
| Does N-Acetylcysteine Decrease Spontaneous Oxidation of Central Neural Dopamine in Parkinson's Disease? [NCT03104725] | Phase 1 | 6 participants (Actual) | Interventional | 2017-09-25 | Terminated(stopped due to Difficulty with recruitment and participant accrual due to study eligibility criteria and required study procedures (e.g., multiple lumbar punctures).) |
| A Randomised Controlled Trial of N-acetylcysteine for the Management of Alcohol Use Disorder [NCT05408247] | Phase 4 | 280 participants (Anticipated) | Interventional | 2023-02-16 | Recruiting |
| A Randomized Placebo Controlled Trial of Intravenous N-Acetylcysteine (NAC) As A Renal Protective Agent for Prevention of Renal Dysfunction Following Cardiopulmonary Bypass (CPB) [NCT00187330] | Phase 2 | 104 participants | Interventional | 2004-03-31 | Completed |
| [NCT00188773] | Phase 4 | 15 participants (Anticipated) | Interventional | 2004-01-31 | Completed |
| Effect of N-Acetylcysteine on Skeletal Muscle in Cachectic Cancer Patients Undergoing a Resistance Training Program (Phase 2 Study) [NCT00196885] | Phase 2 | 60 participants | Interventional | 2003-12-31 | Completed |
| A Pilot Randomized Controlled Trial of Intravenous N-acetyl Cysteine in Patients Undergoing Pharmaco-invasive Reperfusion Early After an ST-segment Elevation Myocardial Infarction [NCT04023266] | Phase 2 | 44 participants (Actual) | Interventional | 2019-09-20 | Completed |
| N-acetylcysteine in Alcohol Dependence [NCT00568087] | Phase 1/Phase 2 | 46 participants (Actual) | Interventional | 2007-12-31 | Completed |
| N-acetylcysteine and NMDA Antagonist Interactions [NCT00611897] | Phase 1/Phase 2 | 16 participants (Actual) | Interventional | 2006-01-31 | Completed |
| Efficacy of N-acetylcysteine for the Prevention and Relief of Paclitaxel-induced Peripheral Neuropathy in Women With Ovarian, Tubal, and Peritoneal Cancer: an Open-label, Randomized Controlled Trial [NCT05539053] | | 60 participants (Anticipated) | Interventional | 2022-11-01 | Recruiting |
| Functional Magnetic Resonance Imaging of N-acetylcysteine in Cocaine Dependence [NCT02994875] | Early Phase 1 | 21 participants (Actual) | Interventional | 2016-05-31 | Completed |
| Glutathione and Function in HIV Patients [NCT02348775] | Phase 1 | 16 participants (Actual) | Interventional | 2014-11-30 | Completed |
| Phase II Randomized Double Blind Trial of Methylprednisolone and N-acetylcysteine in Hepatic Resections. [NCT01726465] | Phase 2 | 50 participants (Actual) | Interventional | 2012-11-30 | Terminated(stopped due to The first phase was completed) |
| Role of N-Acetylcysteine for Prevention of Cisplatin-induced Nephrotoxicity [NCT06019520] | | 70 participants (Anticipated) | Interventional | 2023-08-09 | Active, not recruiting |
| [NCT00267384] | Phase 2/Phase 3 | 0 participants | Interventional | 2006-03-31 | Completed |
| [NCT00237614] | Phase 2/Phase 3 | 300 participants | Interventional | 2003-02-28 | Completed |
| An Open-Label Study of N-Acetyl Cysteine in Pathological Gambling [NCT00273702] | Phase 1 | 36 participants (Actual) | Interventional | 2006-01-31 | Completed |
| Assessment of the Effect of Atorvastatin and N-acetyl Cysteine on Prevention of Contrast Induced Nephropathy in Patients Undergoing Coronary Angiography CIN [NCT06139952] | Phase 4 | 120 participants (Anticipated) | Interventional | 2023-12-01 | Not yet recruiting |
| Reducing Perioperative Oxidative Stress to Prevent Postoperative Chronic Pain Following Total Knee Arthroplasty [NCT06083480] | Phase 4 | 148 participants (Anticipated) | Interventional | 2024-03-31 | Not yet recruiting |
| High-Dose N-Acetylcysteine in Cardiac Surgery Patients at High-Risk of Postoperative Renal Dysfunction. [NCT00332631] | Phase 2 | 60 participants | Interventional | 2004-08-31 | Completed |
| Schizophrenia, Related Troubles and Glutathione: Clinical Trial. Effects of Oral Administration of N-Acetylcysteine (NAC) on the Brain Glutathione Level and on the Symptoms of Schizophrenia: Double-blind and Crossover Study [NCT01506765] | Phase 1 | 13 participants (Actual) | Interventional | 2003-08-31 | Completed |
| Effectiveness of Premedication With Simethicone or Simethicone Plus N-acetylcysteine vs. Placebo in Improving Visibility During Upper Endoscopy. [NCT01653171] | Phase 4 | 230 participants (Actual) | Interventional | 2012-07-31 | Completed |
| Elucidation of Efficacy Mechanism of N-acetylcysteine in Patients With Posttraumatic Stress Disorder: An 8-week Multimodal Neuroimaging and Neurocognitive Study [NCT01664260] | Phase 2 | 0 participants (Actual) | Interventional | 2012-11-01 | Withdrawn(stopped due to The research project has been cancelled before any participants were enrolled.) |
| A Phase I Clinical Trial of the Combination of Famotidine (FAM) and Oral N-Acetyl Cysteine (NAC) Open Label for Outpatient Treatment of Subjects With Newly Diagnosed SARS-CoV-2 Infection [NCT04545008] | Phase 1 | 2 participants (Actual) | Interventional | 2020-10-20 | Terminated(stopped due to Study was stopped due to poor accrual.) |
| Renoprotective Effect of Febuxostat on Contrast Induced Acute Kidney Injury in Chronic Kidney Disease Patients Stage 3 [NCT05264584] | | 120 participants (Actual) | Interventional | 2020-12-01 | Completed |
| A Phase III, Multi-centre, Randomized, Rater- and Patient-blind, Placebo- and Active-controlled, Parallel Group Clinical Trial to Compare the Efficacy and Safety of 1-week Treatment of Intravenous N-acetylcysteine (NAC) 600 mg Twice Daily (Active Test Tre [NCT03843541] | Phase 3 | 333 participants (Actual) | Interventional | 2019-06-25 | Completed |
| Supplementation of N-acetylcysteine and Arachonic Acid in Type 1 Diabetes to Determine Changes in Oxidative Stress [NCT03056014] | Early Phase 1 | 8 participants (Actual) | Interventional | 2018-11-01 | Terminated(stopped due to COVID) |
| Pilot Studies Defining N-Acetyl Cysteine as a Treatment for Inhibiting Prurogenic Stimuli [NCT05287724] | Early Phase 1 | 20 participants (Anticipated) | Interventional | 2022-06-19 | Recruiting |
| Effects of Diesel Exhaust on Airways [NCT01699204] | | 26 participants (Actual) | Interventional | 2007-09-30 | Completed |
| Evaluation of the Effects of N-acetylcysteine on Thyroid Hormone Levels in the Low T3 Syndrome [NCT01501110] | Phase 4 | 83 participants (Actual) | Interventional | 2011-11-30 | Completed |
| N-acetylcysteine for Renal Protection in Patients With Rheumatic Heart Disease Undergoing Valve Replacement. [NCT01704482] | Phase 2 | 60 participants (Actual) | Interventional | 2011-02-28 | Completed |
| Assessment of Safety and Tolerability of Chitosan-N-acetylcysteine Eye Drops in Subjects While Wearing Contact Lenses and Before Insertion of Contact Lenses [NCT01747616] | Phase 1 | 48 participants (Actual) | Interventional | 2011-07-31 | Completed |
| Phase I Study of N-Acetylcysteine to Optimize Metabolic Tumor Microenvironment in CD19 CAR T-cell Therapy in Lymphoma [NCT05081479] | Phase 1 | 32 participants (Anticipated) | Interventional | 2021-12-08 | Recruiting |
| [NCT01753752] | Phase 2 | 32 participants (Actual) | Interventional | 2012-09-30 | Completed |
| Effects of NAC Supplementation on Skeletal Muscle Performance Following Aseptic Injury Induced by Exercise [NCT01778309] | | 20 participants (Actual) | Interventional | 2010-01-31 | Completed |
| A Pilot Study of N-acetylcysteine in Patients With Sickle Cell Disease [NCT01800526] | Phase 1/Phase 2 | 21 participants (Actual) | Interventional | 2013-03-31 | Completed |
| A Pilot Study of N-acetylcysteine in Suspected Thrombotic Thrombocytopenia Purpura [NCT01808521] | Early Phase 1 | 3 participants (Actual) | Interventional | 2013-05-31 | Completed |
| Studying the Role of N-Acetyl Cysteine Either Alone or in Combination With Metronidazole in Treatment of Bacterial Vaginosis [NCT01841411] | Phase 4 | 90 participants (Anticipated) | Interventional | 2013-03-31 | Recruiting |
| Mechanisms of Improving Cognition and Negative Symptoms in Schizophrenia With N-Acetylcysteine: a Magnetic Resonance Spectroscopy Study of Glutamate and Glutathione [NCT02505477] | Phase 4 | 51 participants (Actual) | Interventional | 2017-02-06 | Completed |
| A Double-blind Randomized Placebo-controlled Study of Aspirin and N-acetyl Cysteine as Adjunctive Treatments for Bipolar Disorder Patients (SMRI 11T-009) [NCT01797575] | Phase 2 | 38 participants (Actual) | Interventional | 2013-01-31 | Completed |
| Effect of Anti-oxidants on Beta-cell Function in Humans [NCT01394510] | | 13 participants (Actual) | Interventional | 2011-06-30 | Completed |
| A Multicentre 12-week Randomised Double-blind Placebo Controlled Feasibility Trial of Sodium Benzoate and/or N-acetylcysteine Added to TAU in Patients With Early Schizophrenia Spectrum Disorder. [NCT03510741] | Phase 2 | 64 participants (Actual) | Interventional | 2019-01-01 | Completed |
| A Feasibility Study of N-acetylcysteine for Self-injurious Behavior in Children With Autism Spectrum Disorder [NCT03008889] | Phase 2 | 8 participants (Actual) | Interventional | 2018-07-05 | Completed |
| Efficacy of N-acetylcysteine to Prevent Anti-tuberculosis Drug-induced Liver Injury: A Randomized Controlled Trial [NCT05738681] | Phase 2/Phase 3 | 82 participants (Anticipated) | Interventional | 2022-09-09 | Recruiting |
| Comparison of the Efficacy of Triple Therapy With or Without Acetylcysteine in the First Line of Helicobacter Pylori Infection- A Multicenter Randomized Comparative Trial [NCT02249546] | Phase 4 | 654 participants (Anticipated) | Interventional | 2014-09-30 | Recruiting |
| Comparative Bioavailability Study of N-acetyl-cysteine (NAC) 600 mg Uncoated Tablets vs. NAC 600 mg Film-coated Tablets in Healthy Male and Female Volunteers [NCT02265224] | Phase 1 | 48 participants (Actual) | Interventional | 2014-09-30 | Completed |
| Phase I Study to Evaluate Pharmacokinetics, Safety and Tolerability of Single and Multiple i.v. Doses of N-acetylcysteine (NAC) in Chinese Healthy Volunteers [NCT03881163] | Phase 1 | 24 participants (Actual) | Interventional | 2019-11-11 | Completed |
| A Multi-Center Trial to Study Acute Liver Failure: N-Acetylcysteine (NAC) Open Label Use Study [NCT00896025] | Phase 4 | 255 participants (Actual) | Interventional | 2008-12-31 | Terminated(stopped due to This observational study was stopped after 140 patients were enrolled, no more funds available to continue.) |
| Comparison of Dexamethasone and N Acetylcysteine (NAC) Versus N Acetylcysteine (NAC) Alone in the Prevention of Post Embolization Syndrome in Patients With Hepatocellular Carcinoma Following Transarterial Chemoembolization - Randomized Controlled Trial. [NCT06039280] | | 150 participants (Anticipated) | Interventional | 2023-09-15 | Not yet recruiting |
| Efficacy of N-acetylcysteine on the Craving Symptoms of Abstinent Hospitalized Patients With Cocaine Addiction [NCT03423667] | Phase 2 | 80 participants (Anticipated) | Interventional | 2019-03-01 | Recruiting |
| A Pilot Pre-Phase 1 Clinical Trial to Study How Administering Sublingual Nitric Oxide Donor S-nitroso-N-acetylcysteine Affects the Systemic Blood Pressure in Healthy Human Volunteers. [NCT05798481] | Early Phase 1 | 14 participants (Anticipated) | Interventional | 2024-01-01 | Not yet recruiting |
| Effect of N-Acetylcysteine on Peritoneal Membrane Function in Chronic Peritoneal Dialysis Patients. [NCT00421785] | | 20 participants (Anticipated) | Interventional | 2007-02-28 | Recruiting |
| Translational Neuropsychopharmacology Research of Nicotine Addiction [NCT02723162] | Phase 2 | 67 participants (Actual) | Interventional | 2016-05-04 | Completed |
| Efficacy and Safety of N-acetyl Cysteine for the Prevention of Oral Mucositis After High-dose Chemotherapy and Autologous Hematopoietic Cell Transplantation: a Phase III, Randomized, Open Label, Multi-center Study. [NCT04756622] | Phase 3 | 116 participants (Anticipated) | Interventional | 2021-04-01 | Not yet recruiting |
| Repeated-Dose Oral N-acetylcysteine for the Treatment of Parkinson's Disease [NCT02212678] | Phase 2 | 8 participants (Actual) | Interventional | 2014-09-30 | Completed |
| N-acetylcysteine Plus Naltrexone for the Treatment of Alcohol Dependence [NCT01214083] | Phase 2 | 111 participants (Actual) | Interventional | 2010-10-15 | Completed |
| Phase I-II Trial of High-Dose Acetaminophen With Carmustine in Patients With Metastatic Melanoma [NCT00003346] | Phase 2 | 80 participants (Anticipated) | Interventional | 1997-11-30 | Completed |
| Pilot Study of Losartan and N-acetylcysteine as Inhibitors of Muscle Oxidative Stress in Elderly [NCT01384591] | Phase 1/Phase 2 | 6 participants (Actual) | Interventional | 2011-07-31 | Completed |
| Randomized Trial of Supplementing Glycine and N-acetylcysteine vs. Placebo in COVID-19 [NCT04703036] | Early Phase 1 | 64 participants (Anticipated) | Interventional | 2021-01-11 | Active, not recruiting |
| PILOT: The Effects of Short Term Administration of a Novel Glutathione Precursor (FT061452), on Serum and Intracellular Glutathione Levels [NCT01251315] | Phase 1 | 24 participants (Actual) | Interventional | 2010-12-31 | Completed |
| RENACTIF: Reduction of the Thrombotic Phenotype in Renal Insufficiency With N-AcetylCysteine A Randomized, Double-blind, Placebo-controlled, Cross-over Trial [NCT03636932] | Phase 2 | 40 participants (Actual) | Interventional | 2019-04-30 | Completed |
| Intravenous N-acetylcysteine for the Treatment of Gaucher's Disease and Parkinson's Disease [NCT01427517] | Phase 1 | 9 participants (Actual) | Interventional | 2011-07-31 | Completed |
| Clinical Trial of NAC in Asthma [NCT02605824] | Phase 4 | 1 participants (Actual) | Interventional | 2016-03-31 | Terminated(stopped due to The study was closed after we determined that this albuterol/NAC regimen may be associated with excessive bronchoconstriction.) |
| N-Acetylcysteine for Neuroprotection in Parkinson's Disease [NCT01470027] | Phase 1/Phase 2 | 50 participants (Actual) | Interventional | 2012-01-31 | Completed |
| Inhibition of Lipid Peroxidation and Cerebral Vasospasm by an Acetaminophen-Based Regimen in Patients With Aneurysmal Subarachnoid Hemorrhage [NCT00585559] | Phase 3 | 120 participants (Anticipated) | Interventional | 2007-04-30 | Active, not recruiting |
| N-Acetylcysteine vs Placebo as Adjunctive Treatment in Pediatric Leukemia: A Single Blind, Randomized Controlled Trial [NCT05611086] | Phase 4 | 16 participants (Actual) | Interventional | 2019-08-29 | Terminated(stopped due to The study stopped because the study period already ended) |
| A Phase II Placebo-controlled Intervention Trial of Oral N-acetylcysteine (NAC) for Protection of Human Nevi Against UV-induced Oxidative Stress/Damage in Vivo [NCT01612221] | Phase 2 | 100 participants (Actual) | Interventional | 2012-09-30 | Completed |
| A Controlled Trial of N-Acetylcysteine (NAC) for Cocaine Dependence [NCT00218491] | Phase 2 | 111 participants (Actual) | Interventional | 2005-11-30 | Completed |
| Systemic Vascular Dysfunction in COPD Patients With Mild-to-moderate Airflow Obstruction: Pharmacological Treatment With N-acetylcysteine [NCT02579772] | Phase 4 | 13 participants (Actual) | Interventional | 2015-07-31 | Completed |
| Inhalation of Vapor With Medication (Diclofenac Sodium, Menthol, Methyl Salicylate and N-Acetyl Cysteine) Reduces Oxygen Need and Hospital Stay in COVID-19 Patients - A Case Control Study [NCT04900129] | Phase 1 | 43 participants (Actual) | Interventional | 2020-12-01 | Completed |
| Antioxidant Therapy in RYR1-Related Congenital Myopathy [NCT02362425] | Phase 1/Phase 2 | 63 participants (Actual) | Interventional | 2015-02-12 | Completed |
| An Optimal Dose Finding Study of N-Acetylcysteine in Patients With Myeloproliferative Neoplasms [NCT05123365] | Phase 1/Phase 2 | 27 participants (Anticipated) | Interventional | 2022-01-03 | Active, not recruiting |
| Evaluation of the Addition of N-Acetylcysteine to Topotecan in the Tumor Microenvironment of Persistent or Recurrent High Grade Endometrioid or Serous Ovarian Carcinoma [NCT02569957] | Phase 2 | 1 participants (Actual) | Interventional | 2015-10-02 | Terminated(stopped due to The trial was halted prematurely due to slow accrual.) |
| Protective Role of N-acetylcisteine From Cisplatin-induced Ototoxicity in Patients With Head and Neck Cancer. A Randomized, Placebo Controlled Clinical Trial [NCT03400709] | | 45 participants (Actual) | Interventional | 2015-11-30 | Completed |
| An Open-Label Clinical Trial Conducted Via Telepsychiatry of Complementary and Alternative Treatments (Omega-3 Fatty Acids and Inositol vs. N-acetylcysteine) for the Management of Emotional Dysregulation in Youth [NCT03911414] | Phase 4 | 60 participants (Anticipated) | Interventional | 2019-06-18 | Recruiting |
| Effect of Antioxidant Cocktail in Beta-thalassemia/Hb E Patients [NCT01597765] | | 60 participants (Actual) | Interventional | 2009-06-30 | Completed |
| The Efficacy of N-acetylcysteine on Alleviating Symptom Caused by Lugol Chromoendoscopy: a Prospective, Non-inferiority, Randomized Controlled Trial [NCT04764643] | | 140 participants (Actual) | Interventional | 2020-02-01 | Completed |
| Effects of High-Dose N-Acetylcysteine on Respiratory Health Status in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Chronic Bronchitis: A Randomized, Placebo-Controlled Trial-1 [NCT01599884] | | 65 participants (Anticipated) | Interventional | 2012-06-30 | Not yet recruiting |
| N Acetyl Cysteine Can Decrease the Progression of Renal Disease in Cystinosis Patients [NCT01614431] | Phase 4 | 23 participants (Actual) | Interventional | 2011-03-31 | Completed |
| Effect of N-acetylcysteine on Exacerbations of Bronchiectasis (BENE): a Randomized Controlled Trial [NCT02088216] | | 161 participants (Actual) | Interventional | 2014-04-01 | Completed |
| Prevention of Acute Kidney Injury by N-Acetylcystein in Patients Undergone Cardiac Valve Replacement [NCT03440268] | Phase 4 | 154 participants (Anticipated) | Interventional | 2018-03-15 | Not yet recruiting |
| Prevention of Contrast Nephropathy by Sodium Bicarbonate Versus Sodium Chloride and N-acetylcysteine in Patients Undergoing Cardiac Catheterization [NCT00353340] | | 250 participants (Anticipated) | Interventional | 2005-01-31 | Completed |
| Rare Disease With Microvascular Involvement: High Dose Intravenous N-Acetylcysteine Versus Iloprost for Early, Rapidly Progressive Diffuse Systemic Sclerosis [NCT00428883] | Phase 2/Phase 3 | 45 participants | Interventional | 2007-01-31 | Recruiting |
| Physiological Effects of N-Acetyl Cysteine in Patients With Multiple Sclerosis [NCT03032601] | | 55 participants (Anticipated) | Interventional | 2017-01-05 | Enrolling by invitation |
| Mucolytic Agents and Ventilator-associated Pneumonia in Patients on Invasive Mechanical Ventilation Due to Severe Acute Respiratory Syndrome Coronavirus 2 [NCT04755972] | | 175 participants (Actual) | Interventional | 2020-10-01 | Completed |
| Effect of High-Dose N-acetyl Cysteine (NAC) on the Inflammatory Markers and Clinical Outcome of Patients With Diabetic Peripheral Neuropathy (DPN) [NCT04766450] | Phase 4 | 30 participants (Anticipated) | Interventional | 2021-12-01 | Recruiting |
| A Randomized, Double-Blind Pilot Study of N-Acetylcysteine Mucoadherent Rinse Versus Placebo for Thickened Secretions and Mucositis Secondary to Chemoradiotherapy in the Management of Head and Neck Malignancies [NCT02123511] | Phase 2 | 34 participants (Actual) | Interventional | 2014-04-30 | Completed |
| [NCT01339858] | Phase 4 | 60 participants (Actual) | Interventional | 2011-05-31 | Completed |
| The Effects of Positive Airway Pressure on the Mucolytic Effects of NAC [NCT06152653] | Phase 4 | 20 participants (Anticipated) | Interventional | 2023-11-21 | Recruiting |
| The Role of N-acetyl-l-cysteine (NAC) as an Adjuvant to Opioid Treatment in Patients With Chronic Neuropathic Pain [NCT01840345] | Phase 2 | 11 participants (Actual) | Interventional | 2014-01-31 | Completed |
| A Randomized Placebo-controlled Trial of N-Acetylcysteine in Onychophagia [NCT01993849] | Phase 3 | 23 participants (Actual) | Interventional | 2013-10-31 | Completed |
| A Randomized, Placebo-Controlled Pilot Trial Assessing Two Doses of N-Acetylcysteine on Changes in Oxidative Stress and Endothelial Function in HIV-infected Older Adults Receiving Stable Antiretroviral Therapy [NCT01962961] | Phase 1/Phase 2 | 24 participants (Actual) | Interventional | 2013-10-31 | Completed |
| A Randomised Open Label Exploratory, Safety and Tolerability Study With PP100-01 in Patients Treated With the 12-hour Regimen of N-Acetylcysteine for Paracetamol/Acetaminophen Overdose (The POP Trial) [NCT03177395] | Phase 1 | 24 participants (Actual) | Interventional | 2017-06-08 | Completed |
| Identifying Biological Signatures of N-Acetylcysteine for Non-Suicidal Self-Injury in Adolescents and Young Adults [NCT04005053] | Phase 2 | 44 participants (Actual) | Interventional | 2019-08-01 | Completed |
| Drug Nephrotoxicity Amelioration in Cancer Patients by N-acetylcysteine [NCT06122311] | | 30 participants (Anticipated) | Interventional | 2023-02-20 | Recruiting |
| The Effect of NAC on Lung Function and CT Mucus Score [NCT03822637] | Phase 4 | 30 participants (Anticipated) | Interventional | 2019-02-20 | Recruiting |
| A Phase 2 Trial of N-Acetylcysteine in Biliary Atresia After Kasai Portoenterostomy [NCT03499249] | Phase 2 | 16 participants (Anticipated) | Interventional | 2018-05-18 | Active, not recruiting |
| [NCT00004467] | Phase 3 | 173 participants (Actual) | Interventional | 1998-06-30 | Completed |
| Use of NAC in Alleviation of Hangover Symptoms [NCT02541422] | | 62 participants (Actual) | Interventional | 2015-08-31 | Completed |
| A Randomized Double Blinded Study to Examine the Use of N-Acetyl Cysteine for the Prevention and Treatment of HAAF in Patients With Type 1 Diabetes [NCT02206152] | Phase 1/Phase 2 | 22 participants (Actual) | Interventional | 2015-02-28 | Completed |
| Effect of N-acetylcysteine on Oxidative Stress And Occurrence of Complications in Patients With COVID 19 Infections [NCT04792021] | Phase 3 | 60 participants (Actual) | Interventional | 2021-03-09 | Completed |
| N-acetylcysteine Treatment of Alcohol Use Disorder In Veterans With TBI [NCT02791945] | Phase 2 | 30 participants (Actual) | Interventional | 2016-08-31 | Completed |
| Inpatient Clinical Trial of NAC [NCT03581084] | Phase 4 | 1 participants (Actual) | Interventional | 2018-07-06 | Terminated(stopped due to The study was redesigned to be conducted in an outpatient setting.) |
| Antioxidant Therapy With N-acetylcysteine for Learning and Motor Behavior in Children With Neurofibromatosis Type 1 [NCT04481035] | Phase 2 | 5 participants (Actual) | Interventional | 2019-01-15 | Active, not recruiting |
| A Pilot Trial to Determine the Effective Dose of N-acetylcysteine for Opioid Reduction in Patients Undergoing Spine Surgery. [NCT04562597] | Phase 1/Phase 2 | 50 participants (Actual) | Interventional | 2021-01-20 | Completed |
| Randomized Placebo Controlled Trial of Intravenous N-Acetylcysteine for the Treatment of Acute Ischemic Stroke [NCT04918719] | Phase 2 | 118 participants (Anticipated) | Interventional | 2021-06-01 | Not yet recruiting |
| N-acetylcysteine for the Treatment of Cannabis Dependence: Working Mechanisms [NCT03221231] | Phase 4 | 75 participants (Anticipated) | Interventional | 2016-05-15 | Recruiting |
| Motivation for Cocaine and Non-Drug Reinforcers: Targeting Glutamate Homeostasis [NCT02141620] | Early Phase 1 | 15 participants (Actual) | Interventional | 2014-05-31 | Completed |
| Premedication With Simethicone and N-acetylcysteine in Improving Mucosal Visibility During Upper Endoscopy - a Prospective Double-blinded Randomized Controlled Trial [NCT02357303] | Phase 4 | 300 participants (Actual) | Interventional | 2015-04-30 | Completed |
| Exploratory Efficacy of N-Acetylcysteine in Patients With History of COVID-19 [NCT05736887] | Phase 2 | 80 participants (Anticipated) | Interventional | 2022-05-24 | Active, not recruiting |
| Achieving Cannabis Cessation: Evaluating N-Acetylcysteine Treatment (ACCENT) [NCT01675661] | Phase 3 | 302 participants (Actual) | Interventional | 2014-01-31 | Completed |
| N-acetylcysteine Reduces Acetaldehyde Levels in Binge Alcohol Drinking [NCT05911282] | | 40 participants (Actual) | Interventional | 2021-06-01 | Completed |
| Effectiveness of N-Acetylcysteine in Motivational Enhancement Therapy for Nicotine Addiction: Study on the Dopaminergic Pathways, Changes in Functional Connectivity of fMRI Bold, and Changes in Smoking Abstinence [NCT05903014] | Phase 4 | 88 participants (Anticipated) | Interventional | 2023-01-01 | Recruiting |
| Neuroscience-Informed Treatment Development for Adolescent Alcohol Use [NCT03238300] | Phase 2 | 57 participants (Actual) | Interventional | 2017-10-16 | Completed |
| The Efficacy and Safety of N-acetyl-L-cysteine (NAC) as Adjuvant Therapy in Acute on Chronic Liver Failure (ACLF) A Randomized Double Blind Placebo Controlled Pilot Trial [NCT05089981] | | 100 participants (Anticipated) | Interventional | 2021-11-01 | Not yet recruiting |
| The Clinical Trial of Application of Methylene Blue Vial for Treatment of Covid-19 Patients [NCT04370288] | Phase 1 | 20 participants (Anticipated) | Interventional | 2020-04-19 | Recruiting |
| The Effect of N-acetylcysteine (NAC) on Treatment of Alcohol and Cocaine Use Disorders: A Double-Blind Randomized Controlled Trial. [NCT03018236] | Phase 4 | 100 participants (Anticipated) | Interventional | 2017-01-31 | Recruiting |
| Sperm DNA Damage in β-thalassemia Major: Is There a Role for Antioxidants? [NCT03014882] | Phase 1/Phase 2 | 30 participants (Anticipated) | Interventional | 2015-02-28 | Active, not recruiting |
| Assessment of the Impact of N-acetylcysteine Supplementation on Physical Performance Depending on the Polymorphism of Genes Related to Folate Metabolism [NCT05604586] | | 100 participants (Anticipated) | Interventional | 2022-05-01 | Recruiting |
| N-Acetyl Cysteine add-on to Antidepressant Medication in Therapy Refractory Major Depressive Disorder Patients With Increased Inflammatory Activity [NCT02972398] | | 200 participants (Anticipated) | Interventional | 2015-09-30 | Recruiting |
| A Randomized Double-blind Study of N-AcetylCysteine vs. Placebo to Prevent Neurotoxicity Induced by Platinum Containing Chemotherapy in Patients Treated for (Non)Small Cell Lung Cancer and Malignant Mesothelioma [NCT00637624] | | 69 participants (Actual) | Interventional | 2008-03-31 | Terminated(stopped due to Unable to recruit enough patients) |
| A Proof-of-Concept Trial of N-Acetylcysteine for Adolescent Alcohol Use Disorder [NCT03707951] | Phase 2 | 120 participants (Anticipated) | Interventional | 2019-02-27 | Active, not recruiting |
| N-Acetylcysteine for Youth Cannabis Use Disorder [NCT03055377] | Phase 2/Phase 3 | 192 participants (Anticipated) | Interventional | 2017-08-03 | Active, not recruiting |
| Effects of N-acetylcysteine on Psychosis-like Symptoms and a Neurophysiological Biomarker of the Clinical High Risk for Schizophrenia [NCT05142735] | | 90 participants (Anticipated) | Interventional | 2023-01-13 | Recruiting |
| Effect of Dietary Glycemic Index on Beta-cell Function [NCT01386645] | | 56 participants (Actual) | Interventional | 2011-07-31 | Completed |
| Local Tolerability of Chitosan-N-acetylcysteine Eye Drops in Healthy Young Volunteers [NCT01278784] | Phase 1 | 24 participants (Actual) | Interventional | 2011-03-31 | Completed |
| Safety of N-acetylcysteine in Maternal Chorioamnionitis [NCT00724594] | Phase 1/Phase 2 | 46 participants (Actual) | Interventional | 2008-08-31 | Completed |
| The Combination of High-dose Dexamethasone and Acetylcysteine as the Treatment of Newly-diagnosed Immune Thrombocytopenia: A Single-arm, Open-label Trial [NCT04368598] | Phase 2 | 44 participants (Anticipated) | Interventional | 2019-04-01 | Recruiting |
| Glutathione and Fuel Oxidation in Aging [NCT01870193] | Early Phase 1 | 36 participants (Anticipated) | Interventional | 2013-04-23 | Completed |
| Clinical, Control, Double-blind, Randomized Experimentation With N-acetylcysteine and Bromhexine for COVID-19 [NCT04928495] | Phase 3 | 219 participants (Anticipated) | Interventional | 2021-07-15 | Not yet recruiting |
| Use of N-acetyl Cysteine (NAC) in Alleviation or Prevention of Hangover Symptoms; Independent Alcohol Consumption Protocol [NCT03104959] | | 200 participants (Anticipated) | Interventional | 2016-01-31 | Terminated(stopped due to unable to enroll sufficient number of participants) |
| Glutamatergic Mechanisms in Opioid and Cocaine Co-Use [NCT05610072] | Early Phase 1 | 24 participants (Anticipated) | Interventional | 2022-12-15 | Recruiting |
| Impact of Combining N-acetylcysteine Intravenous Infusion and Intralipid Emulsion Infusion Versus Intralipid Infusion Alone on Myocardial Injury in Aluminum Phosphide Toxicity [NCT05370729] | | 58 participants (Anticipated) | Interventional | 2022-05-31 | Not yet recruiting |
| An Open-Label Trial of N-Acetylcysteine in Cannabis Dependent Adolescents [NCT00542750] | Phase 1/Phase 2 | 24 participants (Actual) | Interventional | 2008-01-31 | Completed |
| N-Acetylcysteine to Prevent Radiocontrast Nephropathy in Emergency Department Patients [NCT00780962] | Phase 2 | 399 participants (Actual) | Interventional | 2007-10-16 | Completed |
| Energetics and Function in Older Humans [NCT02348762] | Phase 1 | 16 participants (Actual) | Interventional | 2014-11-30 | Completed |
| Clinical Trial of Oral Medication for CTD-ILD Treatment [NCT01424033] | Phase 2/Phase 3 | 5 participants (Actual) | Interventional | 2011-12-31 | Terminated(stopped due to Departure of study team) |
| CSP #578 - Prevention of Serious Adverse Events Following Angiography (PRESERVE) [NCT01467466] | Phase 3 | 5,177 participants (Actual) | Interventional | 2013-10-07 | Completed |
| A Phase 1 Open Label Dose Ranging Study to Assess the Safety and Tolerability of N-Acetylcysteine (NAC) in Patients With Retinitis Pigmentosa (FIGHT-RP1 Study) [NCT03063021] | Phase 1 | 30 participants (Actual) | Interventional | 2017-02-15 | Completed |
| The Effect of an Oral Antioxidant, N-Acetyl-L-Cysteine, on Inflammatory and Oxidative Stress Markers in Pulmonary Sarcoidosis [NCT01587001] | | 17 participants (Actual) | Interventional | 2011-11-30 | Completed |
| Comparative Effectiveness of N-acetyl Cysteine, Acetyl L- Carnitine and Medicated Paraffin Oil in Acute Aluminium Phosphide Poisoning: A Clinical Trial [NCT04509258] | Phase 4 | 100 participants (Anticipated) | Interventional | 2020-10-31 | Not yet recruiting |
| Nebulized N-Acetyl Cysteine for Bronchiolitis in Inpatient Hospital Use: A Randomized Controlled Trial [NCT03364218] | Phase 4 | 106 participants (Anticipated) | Interventional | 2018-02-01 | Recruiting |
| Topiramate Augmenting Strategies for the Treatment of Alcohol Use Disorder [NCT03120468] | Early Phase 1 | 16 participants (Anticipated) | Interventional | 2017-05-01 | Active, not recruiting |
| A Randomised Controlled Double Blind Crossover Study of the Effect of a Single Dose of N-acetylcysteine Versus Placebo on Brain Glutamate in Patients With Psychotic Disorders [NCT02483130] | | 20 participants (Actual) | Observational | 2015-06-30 | Completed |
| Physiological Effects of Nutritional Support in Patients With Parkinson's Disease [NCT02445651] | | 51 participants (Actual) | Interventional | 2014-03-31 | Completed |
| Effects of High-Dose N-Acetylcysteine on Respiratory Health Status in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Chronic Bronchitis: A Randomized, Placebo-Controlled Trial-3 [NCT01739790] | | 51 participants (Actual) | Interventional | 2013-01-31 | Terminated(stopped due to PI discretion) |
| Safety and Efficacy of Adding Intravenous N-acetyl Cysteine to Parenteral L-alanyl L-glutamine in Hospitalized Patients Undergoing Colon Surgeries [NCT03589495] | Phase 4 | 60 participants (Actual) | Interventional | 2015-07-30 | Completed |
| The Use of N-acetylcysteine Supplementation in Addition to Night Splinting for Treatment of Mild to Moderate Carpal Tunnel Syndrome: A Randomized, Double-blind, Placebo-controlled Trial [NCT04460521] | Phase 4 | 240 participants (Anticipated) | Interventional | 2021-08-01 | Recruiting |
| A Randomized Controlled Study to Evaluate the Efficacy of Fomepizole in the Treatment of Acetaminophen Overdose [NCT05517668] | Phase 2 | 40 participants (Anticipated) | Interventional | 2022-09-12 | Recruiting |
| Effects of N-acetyl Cysteine on Periprocedural Myocardial Infarction and Major Cardiac and Cerebral Events in Patients Undergoing Percutaneous Coronary Intervention [NCT01878669] | Phase 3 | 390 participants (Anticipated) | Interventional | 2013-01-31 | Active, not recruiting |
| The Effect of N-acetylcysteine in Decreasing the Incidence of Linezolid-induced Thrombocytopenia in Critically Ill Patients [NCT05944458] | Phase 4 | 112 participants (Anticipated) | Interventional | 2023-08-31 | Not yet recruiting |
| NACOS - The Effect of N-acetylcystein for Depressive Symptoms in Patients Suffering From Bipolar Depression - A Double Blind Randomized Placebo-controlled Trial With Follow up [NCT02294591] | Phase 2 | 80 participants (Actual) | Interventional | 2014-11-30 | Completed |
| Evaluation of The Effect of N-AcetylCysteine in The Prevention of Paclitaxel-Induced Peripheral Neuropathy in Cancer Patients [NCT03492047] | Phase 1/Phase 2 | 75 participants (Actual) | Interventional | 2018-04-01 | Completed |
| Efficacy and Safety Study of Acetylcysteine/Doxofylline 1200/400 mg Effervescent Tablet in the Treatment of Moderate-Severe Chronic Obstructive Pulmonary Disease (COPD) [NCT03388853] | Phase 4 | 68 participants (Actual) | Interventional | 2018-02-20 | Completed |
| A Safety and Efficacy Study of N-acetylcysteine in Patients With Transplant-Associated Thrombotic Microangiopathy [NCT03252925] | Phase 3 | 170 participants (Actual) | Interventional | 2017-11-01 | Completed |
| N-Acetyl-cysteine in Early Acute Respiratory Distress Syndrome [NCT03346681] | Early Phase 1 | 0 participants (Actual) | Interventional | 2018-02-01 | Withdrawn(stopped due to no patients enrolled) |
| A Phase 1/2 Pharmacokinetic and Pharmacodynamic Study of NPI-001 Oral Solution Compared to Cysteamine Bitartrate in Cystinosis Patients [NCT05994534] | Phase 1/Phase 2 | 12 participants (Anticipated) | Interventional | 2023-10-29 | Recruiting |
| The Mechanism of Action of N-acetylcysteine for Reducing the Risk of Infection in Alcoholic Hepatitis [NCT03069300] | Phase 3 | 42 participants (Anticipated) | Interventional | 2015-10-01 | Recruiting |
| Effect of N-acetylcysteine as Add on Therapy With Selective Serotonin Reuptake Inhibitors in Moderate to Severe Obsessive Compulsive Disorder Patients [NCT04904952] | | 60 participants (Anticipated) | Interventional | 2020-03-13 | Recruiting |
| Azacitidine (AZA) Combined With N-Acetyl-L-cysteine (NAC) for Prolonged Isolated Thrombocytopenia (PIT) After Hematopoietic Stem Cell Transplantation (HSCT) [NCT05126004] | Phase 2 | 100 participants (Anticipated) | Interventional | 2021-12-01 | Not yet recruiting |
| Efficacy of Percussive Ventilation Therapy (MetaNeb ®) Compared With Mucolytic Agents for Atelectasis in the Mechanically Ventilated Pediatric Patient [NCT02168387] | Phase 4 | 39 participants (Actual) | Interventional | 2010-12-31 | Completed |
| A Novel 4-month Pan-TB Regimen Targeting Both Host and Microbe (panTB-HM) [NCT05686356] | Phase 2/Phase 3 | 352 participants (Anticipated) | Interventional | 2023-07-28 | Recruiting |
| A Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Multiple-Dose, Proof-of-Concept Study to Evaluate the Efficacy of N-acetylcysteine Capsules in the Treatment of the Common Cold (Viral URTI) Associated With Cough in an Adult Population [NCT02379637] | Phase 2 | 70 participants (Actual) | Interventional | 2015-01-31 | Completed |
| Effects of NAC Supplementation on Immune Function, Inflammatory and Performance Responses of Elite Soccer Players Participated in Three Repetitive Games. [NCT04523675] | | 40 participants (Actual) | Interventional | 2016-04-30 | Completed |
| Open-Label Study of N-Acetylcysteine in Children and Adolescents Ages 5-17 With Bipolar I, Bipolar II, and Bipolar Spectrum Disorder [NCT02357290] | Phase 4 | 40 participants (Actual) | Interventional | 2014-01-31 | Completed |
| Effect of the Prophylactic Intervention of N-acetyl-L-cysteine (NAC) on the Incidence of Poor Graft Function and Prolonged Isolated Thrombocytopenia in Acute Leukemia Patients After Haploidentical Hematopoietic Stem Cell Transplantation [NCT03236220] | Phase 2 | 35 participants (Actual) | Interventional | 2017-08-01 | Completed |
| The Effect of N- Acetylcysteine on Inflammatory and Oxidative Stress Biomarkers in Patients With Tobacco Use Disorders and Bipolar Disorders .. [NCT02420418] | | 72 participants (Anticipated) | Interventional | 2015-07-31 | Not yet recruiting |
| Glial Regulators for Treating Comorbid Posttraumatic Stress and Substance Abuse Disorders [NCT02499029] | Phase 2 | 35 participants (Actual) | Interventional | 2013-02-28 | Completed |
| Determination of Efficacy of N-Acetylcysteine in Preventing Those With Mild or Moderate COVID-19 From Progressing to Severe Disease [NCT04419025] | Phase 2 | 165 participants (Actual) | Interventional | 2020-09-23 | Completed |
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] |
| Trial | Outcome |
|---|
| NCT00218491 (1) [back to overview] | Number of Participants That Achieved Study Compliance |
| NCT00248625 (8) [back to overview] | Infectious Complication |
| NCT00248625 (8) [back to overview] | Length of Hospital Stay |
| NCT00248625 (8) [back to overview] | Spontaneous Recovery |
| NCT00248625 (8) [back to overview] | Survival |
| NCT00248625 (8) [back to overview] | Number of Organ Systems Failing |
| NCT00248625 (8) [back to overview] | Categorized Length of ICU Stay |
| NCT00248625 (8) [back to overview] | Cumulative Percent Incidence of Transplantation by 1 Year |
| NCT00248625 (8) [back to overview] | Highest Coma Grade of Hepatic Encephalopathy |
| NCT00332605 (1) [back to overview] | Penn Craving Scale |
| NCT00354770 (1) [back to overview] | Massachusetts General Hospital Hairpulling Scale |
| NCT00374088 (3) [back to overview] | Urine Output |
| NCT00374088 (3) [back to overview] | Maximum Decline in Measured Cardiac Output |
| NCT00374088 (3) [back to overview] | Max Creatinine |
| NCT00453180 (3) [back to overview] | Social Responsiveness Scale |
| NCT00453180 (3) [back to overview] | Aberrant Behavior Checklist |
| NCT00453180 (3) [back to overview] | Vineland Adaptive Behavior Scales-II (VABS-II) |
| NCT00467831 (1) [back to overview] | Survival at 2 Years |
| NCT00539188 (4) [back to overview] | Hamilton Depression Rating Scale (HAM-D) at Baseline |
| NCT00539188 (4) [back to overview] | Self-Harm Inventory (SHI) Score at 6 Weeks |
| NCT00539188 (4) [back to overview] | Self-Harm Inventory (SHI) Score at Baseline |
| NCT00539188 (4) [back to overview] | Hamilton Depression Rating Scale (HAM-D) at 6 Weeks |
| NCT00539513 (4) [back to overview] | Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)at 12 Weeks |
| NCT00539513 (4) [back to overview] | The Hamilton Depression Inventory (HAM-D)at 12 Weeks |
| NCT00539513 (4) [back to overview] | The Hamilton Depression Inventory (HAM-D)at Baseline |
| NCT00539513 (4) [back to overview] | Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)at Baseline |
| NCT00542750 (1) [back to overview] | Feasibility of Recruitment, Measured by Number of Participants Recruited and Retained During Study Period |
| NCT00552786 (2) [back to overview] | Temporary Threshold Changes Measurement by Distortion Product Otoacoustic Emissions (DPOAE) (A Total of Four Hearing Assessments Were Completed for Each Formulation Period on the 1st Day Pre- and Post-shift, and the 14th Day Pre- and Post-shift) |
| NCT00552786 (2) [back to overview] | Temporary Threshold Shift Measurement by Pure Tone Audiometry (A Total of Four Hearing Assessments Were Completed for Each Formulation Period on the 1st Day Pre- and Post-shift, and the 14th Day Pre- and Post-shift) |
| NCT00568087 (4) [back to overview] | The Obsessive Compulsive Drinking Scale |
| NCT00568087 (4) [back to overview] | Liver Function Tests |
| NCT00568087 (4) [back to overview] | Alcohol Consumption (Percentage of Heavy Drinking Days) |
| NCT00568087 (4) [back to overview] | The Penn Alcohol Craving Scale |
| NCT00579995 (1) [back to overview] | Compare the Effectiveness of Two Medications for Prevention of Contrast-induced Nephropathy |
| NCT00611897 (5) [back to overview] | Novel P300 |
| NCT00611897 (5) [back to overview] | Mismatch Negativity (MMN) Intensity |
| NCT00611897 (5) [back to overview] | Mismatch Negativity (MMN) Frequency |
| NCT00611897 (5) [back to overview] | Mismatch Negativity (MMN) Duration |
| NCT00611897 (5) [back to overview] | Target P300 |
| NCT00627705 (4) [back to overview] | The Clinical Global Rating Scale (CGRS) Improvement Subscale Score |
| NCT00627705 (4) [back to overview] | Social Responsiveness Scale (SRS) |
| NCT00627705 (4) [back to overview] | Total Number of Subjects With Reported Side Effects as Assessed by Dosage Record and Treatment Emergent Symptom Scale (DOTES) |
| NCT00627705 (4) [back to overview] | Irritability Subscale of the Aberrant Behavior Checklist (ABC) |
| NCT00650091 (6) [back to overview] | Change in Forced Vital Capacity |
| NCT00650091 (6) [back to overview] | Respiratory Infections |
| NCT00650091 (6) [back to overview] | Overall Change in Forced Vital Capacity |
| NCT00650091 (6) [back to overview] | Number of Participants With Maintained Forced Vital Capacity Response |
| NCT00650091 (6) [back to overview] | Disease Progression |
| NCT00650091 (6) [back to overview] | Acute Exacerbations |
| NCT00655928 (1) [back to overview] | Post-operative Plasma IL-6 |
| NCT00676195 (1) [back to overview] | Number of Participants With Adverse Events Reported on the Dosage Record and Treatment Emergent Symptom Scale (DOTES) |
| NCT00724594 (10) [back to overview] | Prothrombin Time |
| NCT00724594 (10) [back to overview] | Placental Transfer Ratio |
| NCT00724594 (10) [back to overview] | NAC Volume of Distribution |
| NCT00724594 (10) [back to overview] | NAC Total Body Clearance |
| NCT00724594 (10) [back to overview] | NAC Terminal Elimination Half-life |
| NCT00724594 (10) [back to overview] | Maternal and Infant Mean Blood Pressure Change |
| NCT00724594 (10) [back to overview] | Cytokine Level IL-1Ra in Plasma |
| NCT00724594 (10) [back to overview] | Cerebral Blood Flow |
| NCT00724594 (10) [back to overview] | NAC Concentrations |
| NCT00724594 (10) [back to overview] | Magnetic Resonance Spectroscopy of Infants |
| NCT00780962 (1) [back to overview] | Number of Participants With Contrast-induced Nephropathy |
| NCT00809094 (7) [back to overview] | FEF 25-75% (Percent of Predicted) |
| NCT00809094 (7) [back to overview] | FEF 25-75% (L/Sec) |
| NCT00809094 (7) [back to overview] | Change in the Logarithm of the Level of Human Neutrophil Elastase (HNE) Activity Measured in Sputum |
| NCT00809094 (7) [back to overview] | Change in FEV1 (Percent of Predicted for Age) |
| NCT00809094 (7) [back to overview] | Change in ECHO Tricuspid Regurgitation (mm Hg) Over Time by Treatment Group |
| NCT00809094 (7) [back to overview] | Change in DLCO (ml/Min/mmHg) Over Time by Treatment Group |
| NCT00809094 (7) [back to overview] | FEV1 (L) |
| NCT00967005 (24) [back to overview] | Fagerstrom Test for Nicotine Dependence Total Score |
| NCT00967005 (24) [back to overview] | Fagerstrom Test for Nicotine Dependence Total Score |
| NCT00967005 (24) [back to overview] | Fagerstrom Test for Nicotine Dependence Total Score |
| NCT00967005 (24) [back to overview] | Hamilton Anxiety Rating Scale Total Score |
| NCT00967005 (24) [back to overview] | Hamilton Anxiety Rating Scale Total Score |
| NCT00967005 (24) [back to overview] | Hamilton Anxiety Rating Scale Total Score |
| NCT00967005 (24) [back to overview] | Hamilton Anxiety Rating Scale Total Score |
| NCT00967005 (24) [back to overview] | Hamilton Depression Rating Scale Total Score |
| NCT00967005 (24) [back to overview] | Hamilton Depression Rating Scale Total Score |
| NCT00967005 (24) [back to overview] | Hamilton Depression Rating Scale Total Score |
| NCT00967005 (24) [back to overview] | Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Behavior Subscale |
| NCT00967005 (24) [back to overview] | Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Behavior Subscale |
| NCT00967005 (24) [back to overview] | Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Behavior Subscale |
| NCT00967005 (24) [back to overview] | Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Behavior Subscale |
| NCT00967005 (24) [back to overview] | Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Total Score |
| NCT00967005 (24) [back to overview] | Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Total Score |
| NCT00967005 (24) [back to overview] | Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Total Score |
| NCT00967005 (24) [back to overview] | Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Total Score |
| NCT00967005 (24) [back to overview] | Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Urges/Thoughts Subscale |
| NCT00967005 (24) [back to overview] | Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Urges/Thoughts Subscale |
| NCT00967005 (24) [back to overview] | Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Urges/Thoughts Subscale |
| NCT00967005 (24) [back to overview] | Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Urges/Thoughts Subscale |
| NCT00967005 (24) [back to overview] | Hamilton Depression Rating Scale Total Score |
| NCT00967005 (24) [back to overview] | Fagerstrom Test for Nicotine Dependence Total Score |
| NCT00975689 (1) [back to overview] | Oxysterol Levels |
| NCT00993265 (7) [back to overview] | Massachusetts General Hospital Hair Pulling Scale (MGH-HPS) |
| NCT00993265 (7) [back to overview] | Multidimensional Anxiety Scale for Children (MASC) |
| NCT00993265 (7) [back to overview] | Children's Depression Inventory |
| NCT00993265 (7) [back to overview] | The Milwaukee Inventory for Styles of Trichotillomania-Child Version |
| NCT00993265 (7) [back to overview] | Trichotillomania Scale for Children - Parent Version |
| NCT00993265 (7) [back to overview] | Trichotillomania Scale for Children - Child Version |
| NCT00993265 (7) [back to overview] | National Institute of Mental Health -Trichotillomania Severity Scale (NIMH-TSS) |
| NCT01005810 (1) [back to overview] | Percentage of Negative Urine Cannabinoid Tests During Treatment |
| NCT01063348 (2) [back to overview] | Yale Brown Obsessive Compulsive Scale (YBOCS) Modified for PSP (NE-YBOCS) |
| NCT01063348 (2) [back to overview] | Skin Picking Self Assessment Scale (SP-SAS) |
| NCT01118663 (2) [back to overview] | To Evaluate the Incidence of Treatment Emergent Adverse Events |
| NCT01118663 (2) [back to overview] | To Evaluate the Incidence of Anaphylactoid Reaction. |
| NCT01172275 (2) [back to overview] | OCD Severity at 12 Weeks |
| NCT01172275 (2) [back to overview] | Overall Improvement at 12 Weeks |
| NCT01172288 (5) [back to overview] | Overall Improvement |
| NCT01172288 (5) [back to overview] | Number of Participants With Adverse Effects |
| NCT01172288 (5) [back to overview] | Improvement of Premonitory Urges |
| NCT01172288 (5) [back to overview] | Improvement in Tic Severity |
| NCT01172288 (5) [back to overview] | Improvement in OCD Severity |
| NCT01214083 (9) [back to overview] | Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) |
| NCT01214083 (9) [back to overview] | Percentage of Heavy Drinking Days |
| NCT01214083 (9) [back to overview] | Percentage of Drinking Days |
| NCT01214083 (9) [back to overview] | Liver Function Tests (AST) |
| NCT01214083 (9) [back to overview] | Penn Alcohol Craving Scale (PACS) |
| NCT01214083 (9) [back to overview] | Clinical Global Impression (CGI) |
| NCT01214083 (9) [back to overview] | Drinks Per Drinking Days |
| NCT01214083 (9) [back to overview] | Obsessive Compulsive Drinking Scale (OCDS) |
| NCT01214083 (9) [back to overview] | Liver Function Tests (ALT) |
| NCT01232790 (24) [back to overview] | BACS Composite RAW Score |
| NCT01232790 (24) [back to overview] | Letter/Number Sequencing Task Tests for Attention, Concentration & Mental Control (LNS) RAW SCORE. |
| NCT01232790 (24) [back to overview] | Letter/Number Sequencing Task Tests for Attention, Concentration & Mental Control (LNS) RAW SCORE. |
| NCT01232790 (24) [back to overview] | Letter/Number Sequencing Task Tests for Attention, Concentration & Mental Control (LNS) RAW SCORE. |
| NCT01232790 (24) [back to overview] | Letter/Number Sequencing Task Tests for Attention, Concentration & Mental Control (LNS) RAW SCORE. |
| NCT01232790 (24) [back to overview] | Letter/Number Sequencing Task Tests for Attention, Concentration & Mental Control (LNS) RAW SCORE. |
| NCT01232790 (24) [back to overview] | BACS Composite RAW Score |
| NCT01232790 (24) [back to overview] | BACS Composite RAW Score |
| NCT01232790 (24) [back to overview] | BACS Composite RAW Score |
| NCT01232790 (24) [back to overview] | Brief Psychiatric Rating Scale (BPRS)Total Score |
| NCT01232790 (24) [back to overview] | Brief Psychiatric Rating Scale (BPRS)Total Score |
| NCT01232790 (24) [back to overview] | Brief Psychiatric Rating Scale (BPRS)Total Score |
| NCT01232790 (24) [back to overview] | Brief Visuospatial Memory Test (BVMT) RAW SCORE. |
| NCT01232790 (24) [back to overview] | Letter/Number Sequencing Task Tests for Attention, Concentration & Mental Control (LNS) RAW SCORE. |
| NCT01232790 (24) [back to overview] | Letter/Number Sequencing Task Tests for Attention, Concentration & Mental Control (LNS) RAW SCORE. |
| NCT01232790 (24) [back to overview] | Brief Visuospatial Memory Test (BVMT) RAW SCORE. |
| NCT01232790 (24) [back to overview] | BACS Composite RAW Score |
| NCT01232790 (24) [back to overview] | Brief Visuospatial Memory Test (BVMT) RAW SCORE. |
| NCT01232790 (24) [back to overview] | Brief Visuospatial Memory Test (BVMT) RAW SCORE. |
| NCT01232790 (24) [back to overview] | Brief Visuospatial Memory Test (BVMT) RAW SCORE. |
| NCT01232790 (24) [back to overview] | Brief Visuospatial Memory Test (BVMT) RAW SCORE. |
| NCT01232790 (24) [back to overview] | Brief Visuospatial Memory Test (BVMT) RAW SCORE. |
| NCT01232790 (24) [back to overview] | BACS Composite RAW Score |
| NCT01232790 (24) [back to overview] | BACS Composite RAW Score |
| NCT01251315 (2) [back to overview] | Intracellular Glutathione Level |
| NCT01251315 (2) [back to overview] | Augmentation Index |
| NCT01265563 (2) [back to overview] | Change From Baseline in Hemoglobin-A1c |
| NCT01265563 (2) [back to overview] | Change From Baseline in Urinary Albumin Excretion |
| NCT01322009 (2) [back to overview] | Number of Participants Who Experienced Adverse Events |
| NCT01322009 (2) [back to overview] | Antioxidant Reserve |
| NCT01339858 (10) [back to overview] | Symptoms of a Psychotic Disorder |
| NCT01339858 (10) [back to overview] | Mismatch Negativity Voltage Differences |
| NCT01339858 (10) [back to overview] | Working Memory |
| NCT01339858 (10) [back to overview] | Number of Participants With Glutamine/Glutamate Level Changes |
| NCT01339858 (10) [back to overview] | Attention Measures |
| NCT01339858 (10) [back to overview] | Cognitive Functioning |
| NCT01339858 (10) [back to overview] | Cortical Thickness |
| NCT01339858 (10) [back to overview] | Symptoms of a Psychotic Disorder |
| NCT01339858 (10) [back to overview] | Cortical Volume |
| NCT01339858 (10) [back to overview] | Functional Status |
| NCT01354132 (21) [back to overview] | Social and Occupational Functioning Assessment Scale (SOFAS) |
| NCT01354132 (21) [back to overview] | Myo-Inositol Brain Level for the NAC Group |
| NCT01354132 (21) [back to overview] | Change in Cognition and Working Memory (MATRICS) Attention and Vigilance |
| NCT01354132 (21) [back to overview] | GPxbc Glutathione Peroxidase Activity in Blood Cells |
| NCT01354132 (21) [back to overview] | Glutathione Brain Level for Placebo Group |
| NCT01354132 (21) [back to overview] | Glutathione Brain Level for NAC Group |
| NCT01354132 (21) [back to overview] | Glutamine Brain Level for Placebo Group |
| NCT01354132 (21) [back to overview] | Glutamine Brain Level for NAC Group |
| NCT01354132 (21) [back to overview] | Glutamate Brain Level for NAC Group |
| NCT01354132 (21) [back to overview] | Change in Cognition and Working Memory (MATRICS) Reasoning and Problem Solving |
| NCT01354132 (21) [back to overview] | Change in Cognition and Working Memory (MATRICS) Speed of Processing |
| NCT01354132 (21) [back to overview] | Change in Cognition and Working Memory (MATRICS) Verbal Learning |
| NCT01354132 (21) [back to overview] | Change in Cognition and Working Memory (MATRICS) Visual Learning |
| NCT01354132 (21) [back to overview] | Change in Cognition and Working Memory (MATRICS) Working Memory |
| NCT01354132 (21) [back to overview] | Change in Negative Symptoms of Schizophrenia as Measured on the PANSS |
| NCT01354132 (21) [back to overview] | Change in Positive Symptoms (PANSS) |
| NCT01354132 (21) [back to overview] | Change in Blood Level of Glutathione |
| NCT01354132 (21) [back to overview] | Global Assessment of Functioning (GAF) |
| NCT01354132 (21) [back to overview] | Glutamate Brain Level for Placebo Group |
| NCT01354132 (21) [back to overview] | Blood Plasma Level of Cysteine |
| NCT01354132 (21) [back to overview] | Myo-Inositol Brain Level for Placebo Group |
| NCT01384591 (41) [back to overview] | Perceptual Fatigue of Whole Body as Measured by Visual Analog Scale After Handgrip Fatigue Test After Study Intervention |
| NCT01384591 (41) [back to overview] | Perceptual Fatigue of Non-dominant Arm as Measured by Visual Analog Scale Before Handgrip Fatigue Test at Baseline. |
| NCT01384591 (41) [back to overview] | Perceptual Fatigue of Non-dominant Arm as Measured by Visual Analog Scale Before Handgrip Fatigue Test After Study Intervention |
| NCT01384591 (41) [back to overview] | Perceptual Fatigue of Non-dominant Arm as Measured by Visual Analog Scale After Handgrip Fatigue Test at Baseline. |
| NCT01384591 (41) [back to overview] | Leg Blood Flow as Measured by Doppler Ultrasound |
| NCT01384591 (41) [back to overview] | Leg Blood Flow as Measured by Doppler Ultrasound |
| NCT01384591 (41) [back to overview] | Leg Blood Flow as Measured by Doppler Ultrasound |
| NCT01384591 (41) [back to overview] | Leg Blood Flow as Measured by Doppler Ultrasound |
| NCT01384591 (41) [back to overview] | Leg Blood Flow as Measured by Doppler Ultrasound |
| NCT01384591 (41) [back to overview] | Leg Blood Flow as Measured by Doppler Ultrasound |
| NCT01384591 (41) [back to overview] | Leg Blood Flow as Measured by Doppler Ultrasound |
| NCT01384591 (41) [back to overview] | Handgrip Strength of Non-dominant Hand as Measured by Handgrip Dynamometry at 50% Perceived Effort at Baseline |
| NCT01384591 (41) [back to overview] | Handgrip Strength of Non-dominant Hand as Measured by Handgrip Dynamometry at 50% Perceived Effort After All Doses of Study Intervention |
| NCT01384591 (41) [back to overview] | Handgrip Strength of Non-dominant Hand as Measured by Handgrip Dynamometry at 100% Perceived Effort After All Doses of Study Intervention |
| NCT01384591 (41) [back to overview] | Handgrip Strength of Non-dominant Hand as Measured by Handgrip Dynamometry at 100% Effort at Baseline |
| NCT01384591 (41) [back to overview] | Handgrip Strength of Dominant Hand as Measured by Handgrip Dynamometry at 50% Perceived Effort at Baseline |
| NCT01384591 (41) [back to overview] | Handgrip Strength of Dominant Hand as Measured by Handgrip Dynamometry at 50% Perceived Effort After All Doses of Study Intervention |
| NCT01384591 (41) [back to overview] | Handgrip Strength of Dominant Hand as Measured by Handgrip Dynamometry at 100% Perceived Effort After All Doses of Study Intervention |
| NCT01384591 (41) [back to overview] | Handgrip Strength of Dominant Hand as Measured by Handgrip Dynamometry at 100% Effort at Baseline |
| NCT01384591 (41) [back to overview] | Handgrip Fatigue of Non-dominant Hand as Measured by Handgrip Dynamometry at Baseline |
| NCT01384591 (41) [back to overview] | Handgrip Fatigue of Non-dominant Hand as Measured by Handgrip Dynamometry After All Doses of Study Intervention |
| NCT01384591 (41) [back to overview] | Handgrip Fatigue of Dominant Hand as Measured by Handgrip Dynamometry at Baseline |
| NCT01384591 (41) [back to overview] | Handgrip Fatigue of Dominant Hand as Measured by Handgrip Dynamometry After All Doses of Study Intervention |
| NCT01384591 (41) [back to overview] | Global Fatigue Score as Measured by Brief Fatigue Inventory at Baseline |
| NCT01384591 (41) [back to overview] | Global Fatigue Score as Measured by Brief Fatigue Inventory After Study Invention |
| NCT01384591 (41) [back to overview] | Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Total Score at Baseline |
| NCT01384591 (41) [back to overview] | Perceptual Fatigue of Non-dominant Arm as Measured by Visual Analog Scale After Handgrip Fatigue Test After Study Intervention |
| NCT01384591 (41) [back to overview] | Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Total Score After All Doses of Study Intervention |
| NCT01384591 (41) [back to overview] | Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Vigor Fatigue at Baseline |
| NCT01384591 (41) [back to overview] | Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Vigor Fatigue After All Doses of Study Intervention |
| NCT01384591 (41) [back to overview] | Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Physical Fatigue at Baseline |
| NCT01384591 (41) [back to overview] | Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Physical Fatigue After All Doses of Study Intervention |
| NCT01384591 (41) [back to overview] | Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Mental Fatigue at Baseline |
| NCT01384591 (41) [back to overview] | Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Mental Fatigue After All Doses of Study Intervention |
| NCT01384591 (41) [back to overview] | Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale General Fatigue at Baseline |
| NCT01384591 (41) [back to overview] | Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale General Fatigue After All Doses of Study Intervention |
| NCT01384591 (41) [back to overview] | Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Emotional Fatigue at Baseline |
| NCT01384591 (41) [back to overview] | Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Emotional Fatigue After All Doses of Study Intervention |
| NCT01384591 (41) [back to overview] | Perceptual Fatigue of Whole Body as Measured by Visual Analog Scale Before Handgrip Fatigue Test at Baseline. |
| NCT01384591 (41) [back to overview] | Perceptual Fatigue of Whole Body as Measured by Visual Analog Scale Before Handgrip Fatigue Test After Study Intervention |
| NCT01384591 (41) [back to overview] | Perceptual Fatigue of Whole Body as Measured by Visual Analog Scale After Handgrip Fatigue Test at Baseline. |
| NCT01386645 (3) [back to overview] | Urine F2alpha Isoprostanes |
| NCT01386645 (3) [back to overview] | Glycemic Variability |
| NCT01386645 (3) [back to overview] | Disposition Index |
| NCT01394510 (3) [back to overview] | Area Under the Curve for Glucose (AUCg) |
| NCT01394510 (3) [back to overview] | Fasting Urine F2 Alpha Isoprostane Levels |
| NCT01394510 (3) [back to overview] | Oral Disposition Index |
| NCT01424033 (1) [back to overview] | Pulmonary Function Tests |
| NCT01427517 (1) [back to overview] | Brain GSH |
| NCT01467466 (2) [back to overview] | Number of Participants With Serious, Adverse, Patient-Centered Events, Including Death, Need for Acute Dialysis, or Persistent Decline in Kidney Function, Comparing Oral N-Acetylcysteine With Oral Placebo. |
| NCT01467466 (2) [back to overview] | Number of Participants With Serious, Adverse, Patient-Centered Events, Including Death, Need for Acute Dialysis, or Persistent Decline in Kidney Function, Comparing Intravenous Sodium Bicarbonate With Intravenous Sodium Chloride. |
| NCT01470027 (8) [back to overview] | Beck Anxiety Inventory |
| NCT01470027 (8) [back to overview] | 9-Hole Peg Board Test (9-HPT) |
| NCT01470027 (8) [back to overview] | 10-Meter Walk Test |
| NCT01470027 (8) [back to overview] | Parkinson's Disease Quality of Life Questionnaire (PDQLQ) |
| NCT01470027 (8) [back to overview] | Unified Parkinson's Disease Rating Scale (UPDRS) Parts I-V (Total Score Reported) |
| NCT01470027 (8) [back to overview] | Mini Mental State Examination (MMSE) |
| NCT01470027 (8) [back to overview] | Hamilton Depression Rating Scale (HAM-D) |
| NCT01470027 (8) [back to overview] | Change of Cerebral Glutathione Levels as Measured by Proton Magnetic Resonance Spectroscopy |
| NCT01501110 (1) [back to overview] | Serum T3 Levels at 48 Hours |
| NCT01537926 (10) [back to overview] | Retention as Assessed by Number of Participants Who Completed the Study |
| NCT01537926 (10) [back to overview] | Interventricular Septal Thickness (IVST) as Assessed by Echocardiography |
| NCT01537926 (10) [back to overview] | Interventricular Septal Thickness (IVST) as Assessed by Echocardiography |
| NCT01537926 (10) [back to overview] | Left Ventricular End-systolic Diameter (LVESD) as Assessed by Echocardiography |
| NCT01537926 (10) [back to overview] | Left Ventricular End-systolic Diameter (LVESD) as Assessed by Echocardiography |
| NCT01537926 (10) [back to overview] | Left Ventricular Mass (LVM) as Assessed by Echocardiography |
| NCT01537926 (10) [back to overview] | Left Ventricular Mass (LVM) as Assessed by Echocardiography |
| NCT01537926 (10) [back to overview] | Number of Participants With Side Effects Attributable to the Intervention |
| NCT01537926 (10) [back to overview] | Recruitment as Assessed by Number of Participants Who Enrolled to the Study |
| NCT01537926 (10) [back to overview] | Compliance as Assessed by Percentage of Pills Taken by Participant |
| NCT01587001 (2) [back to overview] | Bronchoalveolar Lavage (BAL) Cell Glutathione (GSH) Levels |
| NCT01587001 (2) [back to overview] | Bronchoalveolar Lavage (BAL) and Peripheral Blood Mononuclear Cells (PBMC) TNF-α Levels |
| NCT01612221 (2) [back to overview] | Transcriptional Markers of UV-induced Oxidative Stress in Nevi |
| NCT01612221 (2) [back to overview] | UV-induced Oxidative Stress in Irradiated and Unirradiated Nevi |
| NCT01675661 (1) [back to overview] | The Odds of Negative Urine Cannabinoid Tests During Treatment. |
| NCT01739790 (1) [back to overview] | Changes in the Saint George's Respiratory Questionnaire |
| NCT01797575 (6) [back to overview] | Number of Patients Demonstrating a > 50% Decrease in Depression Scores on the Montgomery-Åsberg Depression Rating Scale (MADRS) |
| NCT01797575 (6) [back to overview] | Number of Patients Demonstrating a > 30% Decrease in Depression Scores on the Montgomery-Åsberg Depression Rating Scale (MADRS) |
| NCT01797575 (6) [back to overview] | Number of Patients Demonstrating a > 30% Decrease in Depression Scores on the Montgomery-Åsberg Depression Rating Scale (MADRS) |
| NCT01797575 (6) [back to overview] | Inflammation as Indicated by Interleukin 6 (IL-6) Levels |
| NCT01797575 (6) [back to overview] | Inflammation as Indicated by C-reactive Protein (CRP) Levels |
| NCT01797575 (6) [back to overview] | Number of Patients Demonstrating a > 50% Decrease in Depression Scores on the Montgomery-Åsberg Depression Rating Scale (MADRS) |
| NCT01840345 (4) [back to overview] | Stress |
| NCT01840345 (4) [back to overview] | Pain |
| NCT01840345 (4) [back to overview] | Opioid Use |
| NCT01840345 (4) [back to overview] | Mood |
| NCT01962961 (3) [back to overview] | Change in Flow-mediated Dilation (FMD) of the Brachial Artery |
| NCT01962961 (3) [back to overview] | Change in Circulating F2-isoprostane Levels |
| NCT01962961 (3) [back to overview] | Change in Circulating Malondialdehyde Levels |
| NCT01993849 (2) [back to overview] | Measurement of Nail Length |
| NCT01993849 (2) [back to overview] | Number of Participants Enrolled Within One Year |
| NCT02088216 (11) [back to overview] | Change in Percentage of Predicted Forced Expiratory Volume in One Second (FEV1%) From Baselines |
| NCT02088216 (11) [back to overview] | Change of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) Scores From Baselines |
| NCT02088216 (11) [back to overview] | Change of Volume of Sputum From Baseline Parameters After the 12-month Follow-up. |
| NCT02088216 (11) [back to overview] | Median Number of Exacerbations |
| NCT02088216 (11) [back to overview] | Time to Recurrent Exacerbations |
| NCT02088216 (11) [back to overview] | Time to the First Exacerbation |
| NCT02088216 (11) [back to overview] | Adverse Events (AEs) (Elevation of Liver Enzymes) |
| NCT02088216 (11) [back to overview] | Nature of Sputum (Number of Patients With Yellow Purulent) |
| NCT02088216 (11) [back to overview] | Change of Forced Vital Capacity (FVC) From Baselines |
| NCT02088216 (11) [back to overview] | Change of Forced Expiratory Volume in One Second (FEV1) (L) From Baselines |
| NCT02088216 (11) [back to overview] | Change of Number of Patients With a Positive Sputum Culture for Pseudomonas Aeruginosa |
| NCT02123511 (10) [back to overview] | EORTC Quality of Life Questionnaire (QLQ) H&N Sticky Saliva AUC |
| NCT02123511 (10) [back to overview] | GRIX Xerostomia Nighttime AUC |
| NCT02123511 (10) [back to overview] | EORTC Quality of Life Questionnaire (QLQ) H&N Pain AUC |
| NCT02123511 (10) [back to overview] | EORTC Quality of Life Questionnaire (QLQ) Swallowing |
| NCT02123511 (10) [back to overview] | Groningen Radiotherapy-Induced Xerostomia (GRIX) Sticky Saliva Nighttime Area Under the Curve (AUC). |
| NCT02123511 (10) [back to overview] | GRIX Xerostiomia Total Score AUC |
| NCT02123511 (10) [back to overview] | GRIX Xerostomia Daytime AUC |
| NCT02123511 (10) [back to overview] | Groningen Radiotherapy-Induced Xerostomia (GRIX) Sticky Saliva Daytime Area Under the Curve (AUC) |
| NCT02123511 (10) [back to overview] | Groningen Radiotherapy-Induced Xerostomia (GRIX) Sticky Saliva Total Score Area Under the Curve (AUC) |
| NCT02123511 (10) [back to overview] | Adverse Event, as Measured by the Number of Patients With a Maximum Grade of Any Adverse Event |
| NCT02141620 (27) [back to overview] | Peak Diastolic Blood Pressure |
| NCT02141620 (27) [back to overview] | Peak Heart Rate |
| NCT02141620 (27) [back to overview] | Peak Score on Sedative Subscale of the Adjective Rating Scale |
| NCT02141620 (27) [back to overview] | Peak Score on Stimulant Subscale of the Adjective Rating Scale |
| NCT02141620 (27) [back to overview] | Peak Systolic Blood Pressure |
| NCT02141620 (27) [back to overview] | "Peak Ratings of Active, Alert, Energetic on the Visual Analog Scale" |
| NCT02141620 (27) [back to overview] | "Peak Ratings of Any Effect on the Visual Analog Scale" |
| NCT02141620 (27) [back to overview] | "Peak Ratings of Bad Effects on the Visual Analog Scale" |
| NCT02141620 (27) [back to overview] | "Peak Ratings of Euphoric on the Visual Analog Scale" |
| NCT02141620 (27) [back to overview] | "Peak Ratings of Good Effects on the Visual Analog Scale" |
| NCT02141620 (27) [back to overview] | "Peak Ratings of High on the Visual Analog Scale" |
| NCT02141620 (27) [back to overview] | "Peak Ratings of Irregular/Racing Heartbeat on the Visual Analog Scale" |
| NCT02141620 (27) [back to overview] | "Peak Ratings of Like Drug on the Visual Analog Scale" |
| NCT02141620 (27) [back to overview] | "Peak Ratings of Nauseous on the Visual Analog Scale" |
| NCT02141620 (27) [back to overview] | "Peak Ratings of Nervous/Anxious on the Visual Analog Scale" |
| NCT02141620 (27) [back to overview] | "Peak Ratings of Performance Impaired on the Visual Analog Scale" |
| NCT02141620 (27) [back to overview] | Peak Temperature |
| NCT02141620 (27) [back to overview] | "Peak Ratings of Performance Improved on the Visual Analog Scale" |
| NCT02141620 (27) [back to overview] | "Peak Ratings of Restless on the Visual Analog Scale" |
| NCT02141620 (27) [back to overview] | "Peak Ratings of Rush on the Visual Analog Scale" |
| NCT02141620 (27) [back to overview] | "Peak Ratings of Shaky/Jittery on the Visual Analog Scale" |
| NCT02141620 (27) [back to overview] | "Peak Ratings of Sluggish/Fatigued/Lazy on the Visual Analog Scale" |
| NCT02141620 (27) [back to overview] | "Peak Ratings of Stimulated on the Visual Analog Scale" |
| NCT02141620 (27) [back to overview] | "Peak Ratings of Talkative/Friendly on the Visual Analog Scale" |
| NCT02141620 (27) [back to overview] | "Peak Ratings of Willing to Pay For on the Visual Analog Scale" |
| NCT02141620 (27) [back to overview] | "Peak Ratings of Willing to Take Again on the Visual Analog Scale" |
| NCT02141620 (27) [back to overview] | Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative |
| NCT02168387 (2) [back to overview] | Change in Capnography (Vd/Vt) |
| NCT02168387 (2) [back to overview] | Improvement of Atelectasis |
| NCT02206152 (1) [back to overview] | Difference in Epinephrine Secretion During the Morning Episodes of Hypoglycemia on Days One and Two Under the Two Treatment Conditions |
| NCT02212678 (1) [back to overview] | Glutathione (GSH) Brain Levels |
| NCT02265224 (7) [back to overview] | Tmax of NAC After Single Dose Administration of Test and Reference |
| NCT02265224 (7) [back to overview] | t1/2 of NAC After Single Dose Administration of Test and Reference |
| NCT02265224 (7) [back to overview] | Lambda Zeta of NAC After Single Dose Administration of Test and Reference |
| NCT02265224 (7) [back to overview] | AUC0-∞ of NAC After Single Dose Administration of Test and Reference |
| NCT02265224 (7) [back to overview] | AUC0-t of NAC After Single Dose Administration of Test and Reference |
| NCT02265224 (7) [back to overview] | Cmax of NAC After Single Dose Administration of Test and Reference |
| NCT02265224 (7) [back to overview] | Frel of NAC After Single Dose Administration of Test and Reference |
| NCT02348775 (1) [back to overview] | Muscle Glutathione Concentration |
| NCT02357290 (2) [back to overview] | Mean Change in the Children's Depression Rating Scale (CDRS) Score |
| NCT02357290 (2) [back to overview] | Mean Change in the Young Mania Rating Scale (YMRS) Score |
| NCT02362425 (56) [back to overview] | Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Trial Outcome Index |
| NCT02362425 (56) [back to overview] | Urine 15-F2t Isoprostane Concentration |
| NCT02362425 (56) [back to overview] | Urine 15-F2t Isoprostane Concentration at Baseline |
| NCT02362425 (56) [back to overview] | Urine 15-F2t Isoprostane Concentration Pre-Intervention |
| NCT02362425 (56) [back to overview] | Walk/Run 10 Meters |
| NCT02362425 (56) [back to overview] | Walk/Run 10 Meters Pre-Intervention |
| NCT02362425 (56) [back to overview] | Adult Patient-Reported Outcomes Measurement Information System (PROMIS) - Fatigue |
| NCT02362425 (56) [back to overview] | Adult Patient-Reported Outcomes Measurement Information System (PROMIS) - Fatigue Pre-Intervention |
| NCT02362425 (56) [back to overview] | Adult Quality of Life in Neurological Disorders (NeuroQoL) Fatigue |
| NCT02362425 (56) [back to overview] | Adult Quality of Life in Neurological Disorders (NeuroQoL) Fatigue Pre-Intervention |
| NCT02362425 (56) [back to overview] | Blood Glutathione Reduced (GSH):Oxidized (GSSG) Ratio |
| NCT02362425 (56) [back to overview] | DCF-fluorescence Intensity (AU) |
| NCT02362425 (56) [back to overview] | DCF-fluorescence Intensity (AU) Pre-Intervention |
| NCT02362425 (56) [back to overview] | Descend Steps |
| NCT02362425 (56) [back to overview] | Descend Steps Pre-Intervention |
| NCT02362425 (56) [back to overview] | Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Total Score |
| NCT02362425 (56) [back to overview] | Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Total Score Pre-Intervention |
| NCT02362425 (56) [back to overview] | Peak Torque Flexion |
| NCT02362425 (56) [back to overview] | Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Trial Outcome Index Pre-Intervention |
| NCT02362425 (56) [back to overview] | Hand Grip Strength |
| NCT02362425 (56) [back to overview] | Hand Grip Strength Pre-Intervention |
| NCT02362425 (56) [back to overview] | Hand Pinch Strength |
| NCT02362425 (56) [back to overview] | Hand Pinch Strength Pre-Intervention |
| NCT02362425 (56) [back to overview] | Motor Function Measure-32 (MFM-32) Domain 1 (D1) |
| NCT02362425 (56) [back to overview] | Motor Function Measure-32 (MFM-32) Domain 1 (D1) Pre-Intervention |
| NCT02362425 (56) [back to overview] | Motor Function Measure-32 (MFM-32) Domain 2 (D2) |
| NCT02362425 (56) [back to overview] | Motor Function Measure-32 (MFM-32) Domain 2 (D2) Pre-Intervention |
| NCT02362425 (56) [back to overview] | Motor Function Measure-32 (MFM-32) Domain 3 (D3) |
| NCT02362425 (56) [back to overview] | Motor Function Measure-32 (MFM-32) Domain 3 (D3) Pre-Intervention |
| NCT02362425 (56) [back to overview] | Motor Function Measure-32 (MFM-32) Total Score |
| NCT02362425 (56) [back to overview] | Motor Function Measure-32 (MFM-32) Total Score Pre-Intervention |
| NCT02362425 (56) [back to overview] | Multidimensional Fatigue Inventory - 20 (MFI-20) General Fatigue Score |
| NCT02362425 (56) [back to overview] | Multidimensional Fatigue Inventory - 20 (MFI-20) General Fatigue Score Pre-Intervention |
| NCT02362425 (56) [back to overview] | Multidimensional Fatigue Inventory-20 (MFI-20) Mental Fatigue Score |
| NCT02362425 (56) [back to overview] | Multidimensional Fatigue Inventory-20 (MFI-20) Mental Fatigue Score Pre-Intervention |
| NCT02362425 (56) [back to overview] | Multidimensional Fatigue Inventory-20 (MFI-20) Physical Fatigue Score |
| NCT02362425 (56) [back to overview] | Multidimensional Fatigue Inventory-20 (MFI-20) Physical Fatigue Score Pre-Intervention |
| NCT02362425 (56) [back to overview] | Multidimensional Fatigue Inventory-20 (MFI-20) Reduced Activity Score |
| NCT02362425 (56) [back to overview] | Multidimensional Fatigue Inventory-20 (MFI-20) Reduced Activity Score Pre-Intervention |
| NCT02362425 (56) [back to overview] | Multidimensional Fatigue Inventory-20 (MFI-20) Reduced Motivation Score |
| NCT02362425 (56) [back to overview] | Multidimensional Fatigue Inventory-20 (MFI-20) Reduced Motivation Score Pre-Intervention |
| NCT02362425 (56) [back to overview] | Peak Torque Extension |
| NCT02362425 (56) [back to overview] | Peak Torque Extension Pre-Intervention |
| NCT02362425 (56) [back to overview] | Peak Torque Flexion Pre-Intervention |
| NCT02362425 (56) [back to overview] | Pediatric Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Total Score |
| NCT02362425 (56) [back to overview] | Pediatric Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Total Score Pre-Intervention |
| NCT02362425 (56) [back to overview] | Pediatric Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue |
| NCT02362425 (56) [back to overview] | Pediatric Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Pre-Intervention |
| NCT02362425 (56) [back to overview] | Pediatric Quality of Life in Neurological Disorders (NeuroQoL) Fatigue |
| NCT02362425 (56) [back to overview] | Pediatric Quality of Life in Neurological Disorders (NeuroQoL) Fatigue Pre-Intervention |
| NCT02362425 (56) [back to overview] | Six Minute Walk Test (6MWT) |
| NCT02362425 (56) [back to overview] | Six Minute Walk Test (6MWT) Pre-Intervention |
| NCT02362425 (56) [back to overview] | Supine to Stand |
| NCT02362425 (56) [back to overview] | Supine to Stand Pre-Intervention |
| NCT02362425 (56) [back to overview] | Time to Ascend Steps (Seconds) |
| NCT02362425 (56) [back to overview] | Time to Ascend Steps (Seconds) Pre-Intervention |
| NCT02379637 (2) [back to overview] | Safety of Daily Dose of NAC (Number of Patients With Adverse Advents) |
| NCT02379637 (2) [back to overview] | Cough Count (Number of Coughs Will be Measured by a 24-hour Ambulatory Cough Monitoring System for the First 72 Hours) |
| NCT02499029 (4) [back to overview] | PTSD Symptoms |
| NCT02499029 (4) [back to overview] | PTSD Symptoms |
| NCT02499029 (4) [back to overview] | Craving |
| NCT02499029 (4) [back to overview] | Depression |
| NCT02541422 (1) [back to overview] | Hangover Symptom Scale |
| NCT02579772 (7) [back to overview] | Plasma Redox Status - Circulating Glutathione |
| NCT02579772 (7) [back to overview] | Change in Skeletal Muscle Deoxygenation - Dynamics (Mean Response Time) |
| NCT02579772 (7) [back to overview] | Change in Central Cardiovascular Function - Cardiac Output |
| NCT02579772 (7) [back to overview] | Exercise Capacity - Time to Exhaustion |
| NCT02579772 (7) [back to overview] | Change in Skeletal Muscle Vascular Function - Capillary Blood Flow Dynamics (Mean Response Time) |
| NCT02579772 (7) [back to overview] | Change in Pulmonary Ventilation - Minute Ventilation (VE) |
| NCT02579772 (7) [back to overview] | Change in Pulmonary Oxygen Uptake - Dynamics (Mean Response Time) |
| NCT02707640 (7) [back to overview] | Percentage of Participants With Dose Reductions |
| NCT02707640 (7) [back to overview] | Percentage of Participants With Early Treatment Discontinuations |
| NCT02707640 (7) [back to overview] | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) |
| NCT02707640 (7) [back to overview] | Percentage of Participants With Treatment-Emergent Adverse Events Resulting in Permanent Discontinuation of Study Treatment |
| NCT02707640 (7) [back to overview] | Percentage of Participants With Treatment-Emergent Deaths of All Causes |
| NCT02707640 (7) [back to overview] | Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs) |
| NCT02707640 (7) [back to overview] | Percentage of Participants With Treatment-Emergent Adverse Events That Led to Dose Reduction or Temporary Discontinuation of Study Treatment |
| NCT02723162 (3) [back to overview] | Number of Cigarettes Smoked Per Day |
| NCT02723162 (3) [back to overview] | rZ Change Score in Resting State Functional Connectivity From Baseline |
| NCT02723162 (3) [back to overview] | Percent Change in Blood Oxygen Level Dependent (BOLD) Signal Response |
| NCT02737358 (3) [back to overview] | Number of Participants With Biochemically-verified Abstinence From Smoking on Days 1-3 of the Protocol. |
| NCT02737358 (3) [back to overview] | Days to Relapse to Smoking Among Abstinent Participants |
| NCT02737358 (3) [back to overview] | Number of Participants With 7-day Point Prevalence Abstinence at the 8-week End-of-treatment Visit |
| NCT02791945 (3) [back to overview] | Change in TBI Symptoms as Assessed by the Neurobehavioral Symptom Inventory (NSI) |
| NCT02791945 (3) [back to overview] | Change in Percent of Heavy Drinking Days Per Week as Assessed by the Timeline Followback (TFLB) |
| NCT02791945 (3) [back to overview] | Change in Number of Standard Drinks Per Week as Assessed by the Timeline Followback (TLFB) |
| NCT02804594 (3) [back to overview] | Change in Level of Blood Markers From Baseline |
| NCT02804594 (3) [back to overview] | Number of Adverse Events Reported Since Baseline Visit That Are Related to N-acetyl Cysteine. |
| NCT02804594 (3) [back to overview] | Change in Fatigue Score on Questionnaires From Baseline |
| NCT02911285 (4) [back to overview] | Change in Post Traumatic Stress Disorder Severity |
| NCT02911285 (4) [back to overview] | Change in Post Traumatic Stress Disorder Severity |
| NCT02911285 (4) [back to overview] | Change in Alcohol Use Disorder Severity |
| NCT02911285 (4) [back to overview] | Change in Alcohol Craving |
| NCT02966873 (6) [back to overview] | Change in Alcohol Craving - Compulsive Subscale |
| NCT02966873 (6) [back to overview] | Change in Alcohol Craving - Obsessive Subscale |
| NCT02966873 (6) [back to overview] | Change in Alcohol Use Severity |
| NCT02966873 (6) [back to overview] | Change in Alcohol Use Severity - Percent Days Abstinent |
| NCT02966873 (6) [back to overview] | Change in Post Traumatic Stress Disorder Symptom Severity - Self Report |
| NCT02966873 (6) [back to overview] | Change in Post Traumatic Stress Disorder Symptom Severity - Clinician Rated |
| NCT03008889 (9) [back to overview] | Successful Collection of Outcome Measures |
| NCT03008889 (9) [back to overview] | Study Medication Compliance |
| NCT03008889 (9) [back to overview] | Number of Self-Injurious Behavior Events |
| NCT03008889 (9) [back to overview] | Percentage of Participants Randomized |
| NCT03008889 (9) [back to overview] | Parent Satisfaction Rating |
| NCT03008889 (9) [back to overview] | Change in Clinical Global Impression (CGI-I) Scale at 9 Weeks Post-intervention |
| NCT03008889 (9) [back to overview] | Attrition Rate |
| NCT03008889 (9) [back to overview] | Aberrant Behavior Checklist Irritability Subscale Score at Baseline and 9 Weeks Post-intervention |
| NCT03008889 (9) [back to overview] | Positive Predictive Value of Screening Method of Classifying Self-injurious Behavior (SIB) by Type. |
| NCT03104725 (3) [back to overview] | Mean Percent Change in Cys-DA/DOPAC Between Pre and Post-treatment Lumbar Puncture With and Without N-acetylcysteine (NAC) |
| NCT03104725 (3) [back to overview] | The Mean Percent Change in Cerebrospinal Fluid (CSF) Concentration of 5-S-cysteinyl-dopamine (Cys-DA) Pre and Post-N-acetylcysteine (NAC) Treatment |
| NCT03104725 (3) [back to overview] | Mean Ratio of Cys-DA/DOPAC Pre and Post-treatment Lumbar Puncture With and Without N-acetylcysteine (NAC) |
| NCT03177395 (24) [back to overview] | K18(U/L) |
| NCT03177395 (24) [back to overview] | miR-122 (Copies/mcL) |
| NCT03177395 (24) [back to overview] | miR-122 (Copies/mcL) |
| NCT03177395 (24) [back to overview] | miR-122 (Copies/mcL) |
| NCT03177395 (24) [back to overview] | miR-122 (Delta Count) |
| NCT03177395 (24) [back to overview] | miR-122 (Delta Count) |
| NCT03177395 (24) [back to overview] | miR-122 (Delta Count) |
| NCT03177395 (24) [back to overview] | Additional NAC Infusion |
| NCT03177395 (24) [back to overview] | Safety Events |
| NCT03177395 (24) [back to overview] | miR-122(Copies/mcL) |
| NCT03177395 (24) [back to overview] | ALT(U/L) |
| NCT03177395 (24) [back to overview] | ALT(U/L) |
| NCT03177395 (24) [back to overview] | ALT(U/L) |
| NCT03177395 (24) [back to overview] | ccK18 (U/L) |
| NCT03177395 (24) [back to overview] | ccK18 (U/L) |
| NCT03177395 (24) [back to overview] | ccK18 (U/L) |
| NCT03177395 (24) [back to overview] | ccK18 (U/L) |
| NCT03177395 (24) [back to overview] | INR |
| NCT03177395 (24) [back to overview] | INR |
| NCT03177395 (24) [back to overview] | INR |
| NCT03177395 (24) [back to overview] | INR |
| NCT03177395 (24) [back to overview] | K18 (U/L) |
| NCT03177395 (24) [back to overview] | K18 (U/L) |
| NCT03177395 (24) [back to overview] | K18 (U/L) |
| NCT03216954 (1) [back to overview] | Number of Alcohol Drinks Chosen |
| NCT03220776 (2) [back to overview] | Prefrontal GABA+ Concentrations |
| NCT03220776 (2) [back to overview] | Prefrontal Glx Concentrations |
| NCT03238300 (2) [back to overview] | Change in Neural Reactivity (as Measured by BOLD: Blood Oxygen Level-Dependent Response) in Reward Regions During Alcohol-cue Reactivity Task. |
| NCT03238300 (2) [back to overview] | Quantifying the Difference in Glutamate Levels (mmol/kg) During N-Acetylcysteine Versus Placebo in the Anterior Cingulate Brain Region. |
| NCT03252925 (2) [back to overview] | The Incidence of TA-TMA. |
| NCT03252925 (2) [back to overview] | The Level of TNF-α |
| NCT03581084 (1) [back to overview] | Forced Expiratory Volume in One Second (FEV1) Measurement |
| NCT03843541 (15) [back to overview] | Change From Baseline to Day 3 and to Day 7 of Mean Sputum Volume of NAC and Placebo |
| NCT03843541 (15) [back to overview] | Change From Baseline to Day 7 in Mean Expectoration Difficulty Score of NAC and Ambroxol Hydrochloride |
| NCT03843541 (15) [back to overview] | Change From Baseline to Day 7 in Mean Sputum Viscosity Score of NAC and Ambroxol Hydrochloride |
| NCT03843541 (15) [back to overview] | Change From Baseline to Day 7 of Mean Sputum Viscosity Score of NAC and Placebo |
| NCT03843541 (15) [back to overview] | Number of Participants With Adverse Events |
| NCT03843541 (15) [back to overview] | Change From Baseline to Day 3 and to Day 7 in Mean Cough Severity Score of Ambroxol Hydrochloride and Placebo |
| NCT03843541 (15) [back to overview] | Change From Baseline to Day 3 and to Day 7 in Mean Cough Severity Score of NAC and Placebo |
| NCT03843541 (15) [back to overview] | Change From Baseline to Day 3 and to Day 7 in Mean Expectoration Difficulty Score of Ambroxol Hydrochloride and Placebo |
| NCT03843541 (15) [back to overview] | Change From Baseline to Day 3 and to Day 7 in Mean Sputum Viscosity Score of Ambroxol Hydrochloride and Placebo |
| NCT03843541 (15) [back to overview] | Change From Baseline to Day 3 and to Day 7 in Mean Sputum Color Score of Ambroxol Hydrochloride and Placebo |
| NCT03843541 (15) [back to overview] | Change From Baseline to Day 3 and to Day 7 in Mean Sputum Color Score of NAC and Placebo |
| NCT03843541 (15) [back to overview] | Change From Baseline to Day 3 and to Day 7 in Mean Sputum Volume of Ambroxol Hydrochloride and Placebo |
| NCT03843541 (15) [back to overview] | Change From Baseline to Day 7 Treatment of Mean Expectoration Difficulty Score of NAC and Placebo |
| NCT03843541 (15) [back to overview] | Change From Baseline to Day 3 in Mean Sputum Viscosity Score of NAC and Placebo |
| NCT03843541 (15) [back to overview] | Change From Baseline to Day 3 in Mean Expectoration Difficulty Score of NAC and Placebo |
| NCT03881163 (18) [back to overview] | Total Body Clearance (CLt) After Single Dose of NAC |
| NCT03881163 (18) [back to overview] | Total Amount of NAC Excreted in Urine From the Last Multiple Dose to 32 h at Steady-state [Aess(0-32)] |
| NCT03881163 (18) [back to overview] | Time to Achieve Css_max (tss_max) After Multiple Doses of NAC |
| NCT03881163 (18) [back to overview] | Time to Achieve Cmax (Tmax) After Single Dose of NAC |
| NCT03881163 (18) [back to overview] | Terminal Elimination Rate Constant (Kel) After Single Dose of NAC |
| NCT03881163 (18) [back to overview] | Percentage of the AUC(0-inf) Obtained by Extrapolation (%AUCextra) |
| NCT03881163 (18) [back to overview] | Half-life (t1/2) After Single Dose of NAC |
| NCT03881163 (18) [back to overview] | Degree of Fluctuation Over One Dosing Interval at Steady-state (DF%) After Multiple Dose of NAC |
| NCT03881163 (18) [back to overview] | Accumulation Ratio After Multiple Doses of NAC |
| NCT03881163 (18) [back to overview] | Total Fraction of NAC Dose Excreted in Urine [Fe(0-t)] After Single Dose of NAC |
| NCT03881163 (18) [back to overview] | Peak Drug Concentration (Cmax) After Single Dose of NAC |
| NCT03881163 (18) [back to overview] | Renal Clearance (CLr) After Single Dose of NAC |
| NCT03881163 (18) [back to overview] | Volume of Distribution (Vd) After Single Dose of NAC |
| NCT03881163 (18) [back to overview] | Plasma Concentration at Steady-state After Multiple Doses of NAC |
| NCT03881163 (18) [back to overview] | Number of Participants With Treatment Emergent Adverse Events (TEAEs) |
| NCT03881163 (18) [back to overview] | Area Under the Concentration-time Curve at Steady State After Multiple Doses of NAC |
| NCT03881163 (18) [back to overview] | Total Amount of NAC Excreted in Urine [Ae(0-t)] After Single Dose of NAC |
| NCT03881163 (18) [back to overview] | Area Under the Concentration-time Curve (AUC) After Single Dose of NAC |
| NCT04005053 (3) [back to overview] | Change in Glutamate Concentrations |
| NCT04005053 (3) [back to overview] | Change in GSH Reduced-to-oxidized Ratio |
| NCT04005053 (3) [back to overview] | Percent Increase in Glutathione (GSH) Concentrations in the ACC |
| NCT04123405 (12) [back to overview] | Number of Responders and Non-responders to Treatment, Per-Protocol Set |
| NCT04123405 (12) [back to overview] | Number of Responders and Non-responders to Treatment, Full Analysis Set |
| NCT04123405 (12) [back to overview] | Sino-Nasal Outcome Test (SNOT-22) by Visit, Full Analysis Set |
| NCT04123405 (12) [back to overview] | Time to Onset of Action, Full Analysis Set |
| NCT04123405 (12) [back to overview] | Sino-Nasal Outcome Test (SNOT-22) by Visit, Per Protocol Set |
| NCT04123405 (12) [back to overview] | Time to Onset of Action, Per-Protocol Set |
| NCT04123405 (12) [back to overview] | Mean Change From Baseline in the Daily Major Symptom Score (MSS) Over the Entire Treatment Period, Full Analysis Set |
| NCT04123405 (12) [back to overview] | Major Symptom Score (MSS) Development Over the Course of the Study, Full Analysis Set |
| NCT04123405 (12) [back to overview] | Major Symptom Score (MSS) Development Over the Course of the Study, Per-protocol Set |
| NCT04123405 (12) [back to overview] | Sino-Nasal Outcome Test (SNOT-22) by Change to Baseline, Full Analysis Set |
| NCT04123405 (12) [back to overview] | Mean Change From Baseline in the Daily Major Symptom Score (MSS) Over the Entire Treatment Period, Per-Protocol Set |
| NCT04123405 (12) [back to overview] | Sino-Nasal Outcome Test (SNOT-22) by Change to Baseline, Per Protocol Set |
| NCT04481035 (3) [back to overview] | Change From Baseline in Motor Function Measured by Physical and Neurological Examination for Subtle Signs (PANESS) |
| NCT04481035 (3) [back to overview] | Transcranial Magnetic Stimulation (TMS) - Cortical Silent Period |
| NCT04481035 (3) [back to overview] | Change From Baseline in ADHD Symptoms as Reported Via Parent/Teacher Surveys |
| NCT04545008 (3) [back to overview] | Time to Symptom Resolution |
| NCT04545008 (3) [back to overview] | Rate of Hospitalization |
| NCT04545008 (3) [back to overview] | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0 |
| NCT04557215 (3) [back to overview] | Change in Stool Form |
| NCT04557215 (3) [back to overview] | Change in Stool Frequency |
| NCT04557215 (3) [back to overview] | Change in Abdominal Pain |
| NCT04562597 (2) [back to overview] | Opioid Consumption Every 6 Hours Post Operative |
| NCT04562597 (2) [back to overview] | Opioid Consumption 12 Hours Post Operative |
Number of Participants That Achieved Study Compliance
Drug and placebo compliance were measured by urine riboflavin levels. Study compliance was defined as 80% or greater weekly urine riboflavin levels equal to or greater than 1500 ng/ml (NCT00218491)
Timeframe: 8 weeks
| Intervention | Participants (Count of Participants) |
|---|
| 1200mg N-Acetylcysteine | 22 |
| 2400mg N-Acetylcysteine | 15 |
| Matching Placebo | 18 |
Infectious Complication
(NCT00248625)
Timeframe: Within 7 days of randomization
| Intervention | Participants (Number) |
|---|
| N-acetylcysteine (NAC) | 20 |
| Placebo | 21 |
Length of Hospital Stay
(NCT00248625)
Timeframe: Randomization to hospital discharge
| Intervention | days (Median) |
|---|
| N-acetylcysteine (NAC) | 103 |
| Placebo | 21 |
Spontaneous Recovery
Survival without liver transplantation (NCT00248625)
Timeframe: One year following randomization
| Intervention | participants (Number) |
|---|
| N-acetylcysteine (NAC) | 33 |
| Placebo | 49 |
Survival
Spontaneous survival without transplant plus survival following transplantation (NCT00248625)
Timeframe: One year following randomization
| Intervention | Participants (Number) |
|---|
| N-acetylcysteine (NAC) | 68 |
| Placebo | 76 |
Number of Organ Systems Failing
(NCT00248625)
Timeframe: Within 7 days of randomization
| Intervention | participants (Number) |
|---|
| 0 | 1 | 2 | 3 | 4 |
|---|
| N-acetylcysteine (NAC) | 44 | 21 | 15 | 11 | 1 |
,| Placebo | 46 | 23 | 12 | 8 | 3 |
Categorized Length of ICU Stay
The length of ICU stay was categorized as number of days in ICU within 7 days of randomization, unless participant either died or received an LTx within this time period. Special categories were created for these cases. (NCT00248625)
Timeframe: Within 7 days of randomization
| Intervention | participants (Number) |
|---|
| 0 days | 1 day | 2 days | 3 days | 4 days | 5 days | 6 days | 7 days | underwent LTx w/i 7 days of randomization | died w/o LTx w/i 7 days of randomization |
|---|
| N-acetylcysteine (NAC) | 29 | 3 | 3 | 2 | 1 | 4 | 5 | 9 | 28 | 8 |
,| Placebo | 34 | 4 | 4 | 0 | 3 | 3 | 3 | 14 | 22 | 5 |
Cumulative Percent Incidence of Transplantation by 1 Year
(NCT00248625)
Timeframe: Within 1 year of randomization
| Intervention | percentage of participants (Number) |
|---|
| N-acetylcysteine (NAC) | 45 |
| Placebo | 35 |
Highest Coma Grade of Hepatic Encephalopathy
West Haven Criteria for hepatic encephalopathy (Grade 0 - IV ) is used for participants > 3 year of age. Coma grade IV indicates a participant who is comatose , with no reflexes, is decerebrate and has abnormal EEG changes with very slow delta activity. For participants less than 3 years the Whittington Scale was used. The Whittington scale does not use EEG changes and has only 3 levels, early (grades I and II), Mid (III) with somnolence, stupor, combativeness and Late (IV) for participants who are comatose with absent reflexes and decerebrate or decorticate posturing. (NCT00248625)
Timeframe: Within 7 days of randomization
| Intervention | participants (Number) |
|---|
| 0 | I | II | III | IV |
|---|
| N-acetylcysteine (NAC) | 28 | 16 | 20 | 15 | 11 |
,| Placebo | 27 | 21 | 19 | 17 | 6 |
Penn Craving Scale
used to measure cravings to use drugs over the past week. Range of TOTAL scores is 0-30. A lower score indicates a better outcome, while a higher score indicates a worse outcome. (NCT00332605)
Timeframe: beginning and at each visit until the end of their participation in the study
| Intervention | units on a scale (Mean) |
|---|
| Naltrexone | 24.0 |
| N-Acetyl Cysteine | 24.0 |
| Placebo | 21.1 |
Massachusetts General Hospital Hairpulling Scale
There is no minimum or maximum score to quantify 'good' or 'poor' improvement based on this scale. The total score can range from 0-28 with zero being no problems to 28 being the most severe score one can receive.A total of 6 assessments were made, however only the final score (the score at the final visit after 12 weeks) was reported here to show the final outcome measure that was used in the final report of possible improvement and what was reported for final publication of data. (NCT00354770)
Timeframe: Baseline and final visit after 12 weeks
| Intervention | units on a scale (Mean) |
|---|
| MGH-HPS Baseline | MGH-HPS Final Visit After 12 Weeks |
|---|
| N-Acetyl Cysteine | 17.6 | 10.4 |
,| Placebo | 16.7 | 16.0 |
Urine Output
Total urine output over the first 24 hours postoperative (NCT00374088)
Timeframe: 24 hours
| Intervention | mL (Mean) |
|---|
| Placebo | 96 |
| N-acetylcysteine | 176 |
Maximum Decline in Measured Cardiac Output
Serial cardiac output was measured by thermodilution. The outcome of maximum decline in indexed cardiac output from 1 hour postoperative to lowest output within 24 hours postoperative was then calculated and compared between NAC and placebo groups. (NCT00374088)
Timeframe: 24 hours
| Intervention | L/min/m2 (Mean) |
|---|
| Placebo | 0.68 |
| N-acetylcysteine | 0.29 |
Max Creatinine
Maximum serum creatinine over first 3 days postoperative. (NCT00374088)
Timeframe: 72 hours
| Intervention | mg/dL (Mean) |
|---|
| Placebo | 0.99 |
| N-acetylcysteine | 0.74 |
Social Responsiveness Scale
The Social Responsiveness Scale (SRS) is a 65-item scale that assesses social impairment in the aspects of social awareness, social cognition, social communication, social motivation and autistic mannerisms. Each item is scored from 0 (not true) to 3 (almost always true). The total SRS raw score may range from 0-195, where higher scores indicate greater severity. (NCT00453180)
Timeframe: Week 12
| Intervention | units on a scale (Mean) |
|---|
| N-acetylcysteine | 85.8 |
| Placebo | 89.1 |
Aberrant Behavior Checklist
The Aberrant Behavior Checklist (ABC) is a 58-item measure of maladaptive behaviors and is used as a measure of drug effects. Each of the 58 items are rated from 0 (not at all) to 3 (severe).The ABC has 5 subscales: Irritability (15 items) ranging from 0 (not at all) to 45 (severe), Lethargy (16 items) ranging from 0 (not at all) to 48 (severe), Stereotypy (7 items) ranging from 0 (not at all) to 21 (severe), Hyperactivity (16 items) ranging from 0 (not at all) to 48 (severe), and Inappropriate Speech (4 items) ranging from 0 (not at all) to 12 (severe). Higher scores indicate a higher level of maladaptive behavior. (NCT00453180)
Timeframe: Week 12
| Intervention | units on a scale (Mean) |
|---|
| Irritablity | Lethargy | Stereotypy | Hyperactivity | Inappropriate Speech |
|---|
| N-acetylcysteine | 14.9 | 10.0 | 3.9 | 17.4 | 4.1 |
,| Placebo | 12.0 | 7.9 | 5.8 | 15.1 | 5.14 |
Vineland Adaptive Behavior Scales-II (VABS-II)
The VABS-II is a semi-structured interview designed to assess adaptive functioning in the domains of communication, daily living skills and socialization. Items in each domain are rated as either 0 (does not), 1(sometimes) or 2(independently) performs a given behavior or skill. The communication domain has 99 items with scores ranging from 0-198. The daily living skills domain has 109 items with scores ranging from 0-218. The socialization domain has 99 items with scores ranging from 0-198. The domains scores are combined to form the adaptive composite score (ranging from 20-160). The raw scores from the communication, daily living skills and socialization domains along with the composite score were selected for use in this study. Higher scores indicate a higher level of adaptive functioning. (NCT00453180)
Timeframe: Week 12
| Intervention | units on a scale (Mean) |
|---|
| Communication | Daily Living Skills | Socialization | Adaptive Behavior Composite |
|---|
| N-acetylcysteine | 88.5 | 99.0 | 71.7 | 62.9 |
,| Placebo | 95.0 | 98.6 | 75.9 | 60.5 |
Survival at 2 Years
The number of subjects surviving after 24 months on study. (NCT00467831)
Timeframe: 24 months
| Intervention | participants (Number) |
|---|
| Multi-Drug Regimen | 0 |
Hamilton Depression Rating Scale (HAM-D) at Baseline
"The Hamilton Rating Scale for Depression is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. Administered by a clinician, The questionnaire is designed for adults and is used to rate the severity of the patients depression by asking their mood, feelings of guilt, insomnia, agitation, weight change, suicidal ideation, and somatic symptoms. The scale also allows the clinician to assess the patient's level of retardation, and insight into their depression. Highest possible score is 52.~HAM-D Scoring 0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severed Depression~≥23 = Very Severe Depression~In this study, Baseline ratings were compared to those of week 6 to assess each participants change in depression throughout the study. A negative value indicates an increase in depression (i.e. the individual felt more depressed) and a positive value indicates a decrease in depression." (NCT00539188)
Timeframe: Baseline
| Intervention | units on a scale (Number) |
|---|
| N-Acetylcysteine | 25 |
| Placebo | 27 |
Self-Harm Inventory (SHI) Score at 6 Weeks
"The Self-Harm Inventory is assessed by asking an individual to answer (yes or no) if they have ever intentionally, or on purpose tried to harm themselves. The inventory contains 22 questions and a 23rd marked other that allows the individual to indicate a self-harm behavior not previously mentioned.~The scoring of this instrument is determined by counting the number of endorsed self-harm behaviors out of the possible twenty-three asked. The maximum score any individual may achieve for the SHI is a 23. Any individual scoring 5 or greater is classified as suffering from BPD.~In this study, scoring on the SHI was primarily used to assess improvement of self-harming symptoms and throughout the study by comparing participant ratings from baseline and week 6. Positive numbers indicate a decrease (i.e. participant indicated less self-harming behavior) and negative numbers indicate an increase in self-harming behaviors reported." (NCT00539188)
Timeframe: 6 weeks
| Intervention | units on a scale (Number) |
|---|
| N-Acetylcysteine | 5 |
| Placebo | 1 |
Self-Harm Inventory (SHI) Score at Baseline
"The Self-Harm Inventory is assessed by asking an individual to answer (yes or no) if they have ever intentionally, or on purpose tried to harm themselves. The inventory contains 22 questions and a 23rd marked other that allows the individual to indicate a self-harm behavior not previously mentioned.~The scoring of this instrument is determined by counting the number of endorsed self-harm behaviors out of the possible twenty-three asked. The maximum score any individual may achieve for the SHI is a 23. Any individual scoring 5 or greater is classified as suffering from BPD.~In this study, scoring on the SHI was primarily used to assess improvement of self-harming symptoms and throughout the study by comparing participant ratings from baseline and week 6. Positive numbers indicate a decrease (i.e. participant indicated less self-harming behavior) and negative numbers indicate an increase in self-harming behaviors reported." (NCT00539188)
Timeframe: Baseline
| Intervention | units on a scale (Number) |
|---|
| N-Acetylcysteine | 8 |
| Placebo | 4 |
Hamilton Depression Rating Scale (HAM-D) at 6 Weeks
"The Hamilton Rating Scale for Depression is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. Administered by a clinician, The questionnaire is designed for adults and is used to rate the severity of the patients depression by asking their mood, feelings of guilt, insomnia, agitation, weight change, suicidal ideation, and somatic symptoms. The scale also allows the clinician to assess the patient's level of retardation, and insight into their depression. Highest possible score is 52.~HAM-D Scoring 0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severed Depression~≥23 = Very Severe Depression~In this study, Baseline ratings were compared to those of week 6 to assess each participants change in depression throughout the study. A negative value indicates an increase in depression (i.e. the individual felt more depressed) and a positive value indicates a decrease in depression." (NCT00539188)
Timeframe: 6 weeks
| Intervention | units on a scale (Number) |
|---|
| N-Acetylcysteine | 28 |
| Placebo | 18 |
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)at 12 Weeks
"The Y-BOCS is a 10 item clinician-rated scale used to both determine the severity of OCD and to monitor symptom improvement throughout the course of the study. The Y-BOCS, specifically measures the severity of symptoms of obsessive-compulsive disorder without being biased towards the type of obsessions or compulsions present. The scale includes questions about the amount of time spent on, how much impairment or distress experienced from, and how much resistance and control over these obsessive thoughts and compulsions.~Each item is rated from 0 (no symptoms) to 4 (extreme symptoms) and yields a total possible score range from 0 to 40, with the following ranges indicating degree of severity:~0-7 = sub-clinical 8-15 = mild 16-23 = moderate 24-31 = severe 32-40 = extreme~In this study, baseline ratings are compared to those of week 12 to produce a percent of change with positive percentages indicating a decrease in symptom severity." (NCT00539513)
Timeframe: 12 Weeks
| Intervention | units on a scale (Mean) |
|---|
| N-Acetylcysteine | 30.6 |
| Placebo | 28.7 |
The Hamilton Depression Inventory (HAM-D)at 12 Weeks
"The Hamilton Rating Scale for Depression is a multiple item (traditionally 17) assessment used to provide an indication of depression and as a guide to evaluate recovery. The clinician-rated assessment is designed for adults and is used to rate the severity of patient depression by asking about mood, feelings of guilt, insomnia, agitation, weight change, suicidal ideation, and somatic symptoms. The scale also allows the clinician to assess the patient's level of retardation, and insight into their depression.~In this study, the HAM-D17 (17 items scored) was used to obtain depression severity ratings with a maximum possible score of 52. Baseline ratings are compared to those of week 12 to produce a percentage of change, where positive values indicate a decrease in depressive severity/symptoms. Maximum score is a 52.~Ranges~0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression~≥23 = Very Severe Depression" (NCT00539513)
Timeframe: 12 weeks
| Intervention | units on a scale (Mean) |
|---|
| N-Acetylcysteine | 12.1 |
| Placebo | 7.0 |
The Hamilton Depression Inventory (HAM-D)at Baseline
"The Hamilton Rating Scale for Depression is a multiple item (traditionally 17) assessment used to provide an indication of depression and as a guide to evaluate recovery. The clinician-rated assessment is designed for adults and is used to rate the severity of patient depression by asking about mood, feelings of guilt, insomnia, agitation, weight change, suicidal ideation, and somatic symptoms. The scale also allows the clinician to assess the patient's level of retardation, and insight into their depression.~In this study, the HAM-D17 (17 items scored) was used to obtain depression severity ratings with a maximum possible score of 52. Baseline ratings are compared to those of week 12 to produce a percentage of change, where positive values indicate a decrease in depressive severity/symptoms. Maximum score is a 52.~Ranges~0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression~≥23 = Very Severe Depression" (NCT00539513)
Timeframe: Baseline
| Intervention | units on a scale (Mean) |
|---|
| N-Acetylcysteine | 17.3 |
| Placebo | 8.7 |
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)at Baseline
"The Y-BOCS is a 10 item clinician-rated scale used to both determine the severity of OCD and to monitor symptom improvement throughout the course of the study. The Y-BOCS, specifically measures the severity of symptoms of obsessive-compulsive disorder without being biased towards the type of obsessions or compulsions present. The scale includes questions about the amount of time spent on, how much impairment or distress experienced from, and how much resistance and control over these obsessive thoughts and compulsions.~Each item is rated from 0 (no symptoms) to 4 (extreme symptoms) and yields a total possible score range from 0 to 40, with the following ranges indicating degree of severity:~0-7 = sub-clinical 8-15 = mild 16-23 = moderate 24-31 = severe 32-40 = extreme~In this study, baseline ratings are compared to those of week 12 to produce a percent of change with positive percentages indicating a decrease in symptom severity." (NCT00539513)
Timeframe: Baseline
| Intervention | units on a scale (Mean) |
|---|
| N-Acetylcysteine | 30.3 |
| Placebo | 28.6 |
Feasibility of Recruitment, Measured by Number of Participants Recruited and Retained During Study Period
Feasibility of recruiting and retaining participants during the study period. This is the primary outcome of interest for this proof-of-concept feasibility preliminary study. (NCT00542750)
Timeframe: one year
| Intervention | Participants (Number) |
|---|
| N-acetylcysteine | 24 |
Temporary Threshold Changes Measurement by Distortion Product Otoacoustic Emissions (DPOAE) (A Total of Four Hearing Assessments Were Completed for Each Formulation Period on the 1st Day Pre- and Post-shift, and the 14th Day Pre- and Post-shift)
Distortion product otoacoustic emissions (DPOAE) is an objective measure to assess the cochlear changes. DPOAE response threshold at high frequency (HF) was defined as the average of response levels (dB SPL) at 3k,4k,6kHz for each ear examined. A total of four hearing assessments by DPOAE were completed for each formulation period on the 1st day pre- and post-shift, and the 14th day pre- and post-shift. The amount of DPOAE temporary threshold change was calculated by subtracting the pre-shift DPOAE response threshold from the post-shift DPOAE response threshold at each frequency. (NCT00552786)
Timeframe: A total of four hearing assessments were completed for each formulation period on the 1st day pre- and post-shift, and the 14th day pre- and post-shift
| Intervention | decibels (dB SPL) (Mean) |
|---|
| N-acetylcysteine (NAC) | -0.85 |
| Placebo | -0.89 |
Temporary Threshold Shift Measurement by Pure Tone Audiometry (A Total of Four Hearing Assessments Were Completed for Each Formulation Period on the 1st Day Pre- and Post-shift, and the 14th Day Pre- and Post-shift)
The hearing threshold level (HL) at high frequency (HF) by pure-tone audiometry (PTA) was defined as the average of HLs at 3k,4k,6kHz for each ear examined. A total of four hearing assessments by PTA were completed for each formulation period on the 1st day pre- and post-shift, and the 14th day pre- and post-shift. The amount of temporary threshold change was calculated by subtracting the pre-shift hearing threshold from the post-shift hearing threshold at each frequency. (NCT00552786)
Timeframe: A total of four hearing assessments were completed for each formulation period on the 1st day pre- and post-shift, and the 14th day pre- and post-shift
| Intervention | decibels (Mean) |
|---|
| N-acetylcysteine (NAC) | 3.4 |
| Placebo | 2.7 |
The Obsessive Compulsive Drinking Scale
"Alcohol craving was secondary a priori outcome measure. Alcohol craving was measured at each weekly visit during the 8 weeks--from week 1 (before starting intervention) to week 9 (after completing intervention).~The Obsessive Compulsive Drinking Scale is a self-rated scale designed to assess alcohol craving. The score range of the Obsessive Compulsive Drinking Scale is between 0 and 56, with 56 assigned to the highest (worst) alcohol craving." (NCT00568087)
Timeframe: The Obsessive Compulsive Drinking Scale was measured at each weekly visit during the 8 weeks.
| Intervention | score on a scale (Mean) |
|---|
| Obsessive Compulsive Drinking Scale at week 1 | Obsessive Compulsive Drinking Scale at week 9 |
|---|
| N-acetylcysteine | 29.0 | 13.8 |
,| Placebo | 27.6 | 17.0 |
Liver Function Tests
Aspartate aminotransaminase (AST) plasma level (NCT00568087)
Timeframe: 8 weeks
| Intervention | U/L (Mean) |
|---|
| AST at week 0 | AST at week 9 |
|---|
| N-acetylcysteine | 40.89 | 26.13 |
,| Placebo | 35.85 | 31.53 |
Alcohol Consumption (Percentage of Heavy Drinking Days)
The percentage of heavy drinking days was primary a priori outcome measure. Heavy drinking was defined as ≥ 5 standard drinks per day for men and ≥ 4 standard drinks for women. One standard drink is any drink containing about 0.6 fluid ounces or 14 grams of pure alcohol. The percentage of heavy drinking days (HDD) was measured at each weekly visit during the 8 weeks--from week 1 (before starting intervention) to week 9 (after completing intervention). At each week, the percentage of HDD was calculated during the period (usually 7 days) since the last previous visit. (NCT00568087)
Timeframe: The percentage of heavy drinking days (HDD) was measured at each weekly visit during the 8 weeks.
| Intervention | percentage of heavy drinking days (Mean) |
|---|
| Percentage of heavy drinking days at week 1 | Percentage of heavy drinking days at week 9 |
|---|
| N-acetylcysteine | 70.2 | 20.2 |
,| Placebo | 58.4 | 14.7 |
The Penn Alcohol Craving Scale
"Alcohol craving was secondary a priori outcome measure. Alcohol craving was measured at each weekly visit during the 8 weeks--from week 1 (before starting intervention) to week 9 (after completing intervention).~The Penn Alcohol Craving Scale is a self-rated scale designed to assess alcohol craving. The score range of the Penn Alcohol Craving Scale is between 0 and 30, with 30 assigned to the highest (worst) alcohol craving." (NCT00568087)
Timeframe: The Penn Alcohol Craving Scale was measured at each weekly visit during the 8 weeks.
| Intervention | score on a scale (Mean) |
|---|
| Penn Alcohol Craving Scale at week 1 | Penn Alcohol Craving Scale at week 9 |
|---|
| N-acetylcysteine | 18.1 | 7.2 |
,| Placebo | 18.0 | 11.5 |
Compare the Effectiveness of Two Medications for Prevention of Contrast-induced Nephropathy
Compare oral N-Acetylcysteine and intravenous sodium bicarbonate for the prevention of contrast-induced nephropathy in high-risk patients undergoing cardiac catheterization. (NCT00579995)
Timeframe: 2 years
| Intervention | milligrams per deciliter (Mean) |
|---|
| 1, N-Acetylcysteine | NA |
| 2, Sodium Bicarbonate | NA |
Novel P300
"The Novel P300 measures were obtained from the Fz, Cz and Pz electrodes.~Target stimuli were 1000 Hz tones (500 ms) and novel stimuli (~250 ms) were unique environmental sounds (e.g., dog bark) used in prior studies of the novelty P300. Subjects were instructed to respond to the target sounds by pressing a button using their dominant hand index finger. The standard stimuli were 20, 30 or 40 Hz click trains (500 ms) in the first, second, and third runs, respectively. The auditory steady state EEG driving data obtained from these standard stimuli will be presented in a separate report. All stimuli were presented at 80 dB SPL." (NCT00611897)
Timeframe: daily
| Intervention | microvolts (Least Squares Mean) |
|---|
| Fz | Cz | Pz |
|---|
| NAC+Ketamine | 5.3 | 7.4 | 6.1 |
,| NAC+Saline | 7.6 | 11.5 | 10.8 |
,| Placebo+Ketamine | 5.2 | 7.0 | 5.7 |
,| Placebo+Saline | 5.6 | 10.5 | 10.7 |
Mismatch Negativity (MMN) Intensity
"Mismatch Negativity (MMN) Intensity difference waves at midline electrodes (Fz, Cz and Pz).~The frequent standard tones were of 75 ms duration with 5 ms rise and fall time, and were composed of 500, 1000, and 1500 Hz sinusoidal partials (harmonics) that resulted in a single high pitched beep sound.~All tones were presented at 76 dB sound pressure level (SPL) with the exception of intensity deviants. The three deviants were distinguishable from standard tones in either intensity, frequency, or duration.~Subjects performed a visual discrimination distractor task during the MMN runs and were instructed to ignore the tones.~The mismatch negativity (MMN) measure included 3 types of deviant tones (stimuli) that the subjects heard: 1. Frequency deviant, 2. Intensity deviant, 3. Duration deviant. The response to these 3 types of deviants were recorded in the EEG. Therefore each deviant was associated with different waves which we measured in amplitude (microvolts)" (NCT00611897)
Timeframe: daily
| Intervention | microvolts (Least Squares Mean) |
|---|
| Fz | Cz | Pz |
|---|
| NAC+Ketamine | -2.6 | -2.6 | -2.1 |
,| NAC+Saline | -3.4 | -3.4 | -2.4 |
,| Placebo+Ketamine | -2.7 | -2.5 | -2.0 |
,| Placebo+Saline | -3.5 | -3.2 | -2.1 |
Mismatch Negativity (MMN) Frequency
"Mismatch Negativity (MMN) Frequency difference waves at midline electrodes (Fx, Cz and Pz).~The frequent standard tones were of 75 ms duration with 5 ms rise and fall time, and were composed of 500, 1000, and 1500 Hz sinusoidal partials (harmonics) that resulted in a single high pitched beep sound.~All tones were presented at 76 dB sound pressure level (SPL) with the exception of intensity deviants. The three deviants were distinguishable from standard tones in either intensity, frequency, or duration.~Subjects performed a visual discrimination distractor task during the MMN runs and were instructed to ignore the tones.~The mismatch negativity (MMN) measure included 3 types of deviant tones (stimuli) that the subjects heard: 1. Frequency deviant, 2. Intensity deviant, 3. Duration deviant. The response to these 3 types of deviants were recorded in the EEG. Therefore each deviant was associated with different waves which we measured in amplitude (microvolts)" (NCT00611897)
Timeframe: daily
| Intervention | microvolts (Least Squares Mean) |
|---|
| Fz | Cz | Pz |
|---|
| NAC+Ketamine | -2.9 | -2.9 | -1.9 |
,| NAC+Saline | -3.1 | -3.1 | -1.8 |
,| Placebo+Ketamine | -2.7 | -2.7 | -1.7 |
,| Placebo+Saline | -3.3 | -3.3 | -2.3 |
Mismatch Negativity (MMN) Duration
"Mismatch Negativity (MMN) Duration difference waves at midline electrodes (Fz, Cz and Pz).~The frequent standard tones were of 75 ms duration with 5 ms rise and fall time, and were composed of 500, 1000, and 1500 Hz sinusoidal partials (harmonics) that resulted in a single high pitched beep sound.~All tones were presented at 76 dB sound pressure level (SPL) with the exception of intensity deviants. The three deviants were distinguishable from standard tones in either intensity, frequency, or duration.~Subjects performed a visual discrimination distractor task during the MMN runs and were instructed to ignore the tones.~The mismatch negativity (MMN) measure included 3 types of deviant tones (stimuli) that the subjects heard: 1. Frequency deviant, 2. Intensity deviant, 3. Duration deviant. The response to these 3 types of deviants were recorded in the EEG. Therefore each deviant was associated with different waves which we measured in amplitude (microvolts)" (NCT00611897)
Timeframe: daily
| Intervention | microvolts (Least Squares Mean) |
|---|
| Fz | Cz | Pz |
|---|
| NAC+Ketamine | -2.8 | -2.8 | -2.1 |
,| NAC+Saline | -3.2 | -3.3 | -2.4 |
,| Placebo+Ketamine | -3.1 | -3.1 | -2.3 |
,| Placebo+Saline | -3.2 | -3.1 | -2.4 |
Target P300
"The Target P300 measures were obtained from the Fz, Cz and Pz electrodes.~Target stimuli were 1000 Hz tones (500 ms) and novel stimuli (~250 ms) were unique environmental sounds (e.g., dog bark) used in prior studies of the novelty P300. Subjects were instructed to respond to the target sounds by pressing a button using their dominant hand index finger. The standard stimuli were 20, 30 or 40 Hz click trains (500 ms) in the first, second, and third runs, respectively. The auditory steady state EEG driving data obtained from these standard stimuli will be presented in a separate report. All stimuli were presented at 80 dB SPL." (NCT00611897)
Timeframe: daily
| Intervention | microvolts (Least Squares Mean) |
|---|
| Fz | Cz | Pz |
|---|
| NAC+Ketamine | 3.4 | 5.4 | 8.2 |
,| NAC+Saline | 5.2 | 9.9 | 12.6 |
,| Placebo+Ketamine | 3.2 | 5.5 | 8.1 |
,| Placebo+Saline | 2.5 | 7.7 | 11.8 |
The Clinical Global Rating Scale (CGRS) Improvement Subscale Score
Score range 1-7 (lower score mean more improvement compared to baseline) (NCT00627705)
Timeframe: 12 weeks
| Intervention | score (range 1-7) (Mean) |
|---|
| N-Acetyl Cysteine | 3.2 |
| Sugar Pill | 2.9 |
Social Responsiveness Scale (SRS)
SRS total score (range 0-195); higher scores mean more social impairment (NCT00627705)
Timeframe: 12 weeks
| Intervention | SRS total score (range 0-195) (Mean) |
|---|
| Baseline SRS Total Score | Week 12 SRS Total Score |
|---|
| N-Acetyl Cysteine | 111.9 | 93.8 |
,| Sugar Pill | 104.7 | 98.5 |
Total Number of Subjects With Reported Side Effects as Assessed by Dosage Record and Treatment Emergent Symptom Scale (DOTES)
The Dosage Record and Treatment Emergent Symptom Scale (DOTES) provides information on the presence, frequency, and severity of side effects reported during the course of the trial. (NCT00627705)
Timeframe: 4, 8, and 12 weeks
| Intervention | participants (Number) |
|---|
| Total Number of Subjects with GI adverse Events | Constipation | Nausea/Vomiting | Diarrhea | Increased Appetite | Decreased Appetite | Akathisia | Excitement/Agitation | Increased Motor Activity | Tremor | Syncope/Dizziness | Depressive Affect | Nasal Congestion | Increased Salivation | Sweating |
|---|
| N-Acetyl Cysteine | 11 | 3 | 6 | 3 | 2 | 2 | 1 | 2 | 2 | 0 | 0 | 1 | 4 | 0 | 0 |
,| Sugar Pill | 7 | 2 | 3 | 1 | 0 | 3 | 0 | 3 | 3 | 1 | 1 | 0 | 6 | 2 | 1 |
Irritability Subscale of the Aberrant Behavior Checklist (ABC)
Aberrant Behavior Checklist (ABC) Irritability Subscale Score (range 0-45); higher scores mean higher irritability (NCT00627705)
Timeframe: baseline and 12 weeks
| Intervention | Score (range 0-45) (Mean) |
|---|
| Baseline ABC-I Score | Week 12 ABC-I Score |
|---|
| N-Acetyl Cysteine | 16.9 | 7.2 |
,| Sugar Pill | 14.8 | 13.1 |
Change in Forced Vital Capacity
Change from Baseline in Forced Vital Capacity at 15, 30, 45, and 60 weeks (units in liters) (NCT00650091)
Timeframe: Baseline, 15, 30, 45, 60 week
| Intervention | liters (Mean) |
|---|
| 15 week | 30 week | 45 week | 60 week |
|---|
| N-Acetylcysteine | -0.07 | -0.07 | -0.15 | -0.16 |
,| Placebo | -0.04 | -0.08 | -0.15 | -0.15 |
Respiratory Infections
(NCT00650091)
Timeframe: Measured at Week 60
| Intervention | events (Number) |
|---|
| N-Acetylcysteine | 6 |
| Placebo | 6 |
Overall Change in Forced Vital Capacity
Change from Baseline in Forced Vital Capacity at 60 weeks (units in liters) (NCT00650091)
Timeframe: Measured as the estimated change from baseline to Week 60
| Intervention | liters (Mean) |
|---|
| N-Acetylcysteine | -0.18 |
| Placebo | -0.19 |
Number of Participants With Maintained Forced Vital Capacity Response
Maintained forced vital capacity response was a binary variable taking on a value of 1 for participants with higher FVC % predicted at week 60 compared to baseline. (NCT00650091)
Timeframe: Measured at Week 60
| Intervention | participants (Number) |
|---|
| N-Acetylcysteine | 29 |
| Placebo | 35 |
Disease Progression
"The time-to-death or a 10% decline in FVC will be defined as the time-to-disease progression.~The 10% decline in FVC from enrollment must be confirmed on 2 consecutive visits no less than 6 weeks apart. For subjects with 2 consecutive visits with a 10% decline in FVC, the time-to-disease progression will be defined as the time interval between enrollment and the initial visit with a 10% FVC decline." (NCT00650091)
Timeframe: Measured at Week 60
| Intervention | percentage of participants (Number) |
|---|
| N-Acetylcysteine | 27.1 |
| Placebo | 26.5 |
Acute Exacerbations
"The following 3 criteria will define acute exacerbations in subjects with acute worsening of their respiratory conditions:~1. Clinical (all of the following required): A) Unexplained worsening of dyspnea or cough within 30 days, triggering unscheduled medical care (e.g., emergency room, clinic, study visit, hospitalization). B) No clinical suspicion or overt evidence of cardiac event, pulmonary embolism, or deep venous thrombosis to explain acute worsening of dyspnea. C) No pneumothorax." (NCT00650091)
Timeframe: Measured at Week 60
| Intervention | events (Number) |
|---|
| N-Acetylcysteine | 3 |
| Placebo | 3 |
Post-operative Plasma IL-6
Plasma IL-6 was measured in duplicate using ELISA. (NCT00655928)
Timeframe: Post operative, 24 hours
| Intervention | pg/ml (Mean) |
|---|
| N-acetylcysteine | 126 |
| Placebo | 111 |
Number of Participants With Adverse Events Reported on the Dosage Record and Treatment Emergent Symptom Scale (DOTES)
Number of Participants with adverse events reported on the Dosage Record and Treatment Emergent Symptom Scale (DOTES) during the course of the study as measured at time points (4, 8, and 12 weeks). (NCT00676195)
Timeframe: 4, 8, and 12 weeks
| Intervention | number of participants (Number) |
|---|
| N-Acetyl Cysteine | 17 |
Prothrombin Time
prothrombin clotting time (NCT00724594)
Timeframe: after N-acetylcystiene or saline infusion
| Intervention | seconds (Mean) |
|---|
| NAC Infant | 19.5 |
| Control Infant | 19.0 |
| NAC Maternal | 14.2 |
| Control Maternal | 14.4 |
Placental Transfer Ratio
Ratio of NAC concentration in cord to maternal venous blood (NCT00724594)
Timeframe: At time of delivery
| Intervention | ratio (Mean) |
|---|
| NAC Maternal | 1.4 |
NAC Volume of Distribution
(NCT00724594)
Timeframe: prior to delivery in mothers, and in newborn after delivery during 2 days of NAC infusion
| Intervention | L/kg (Mean) |
|---|
| NAC Maternal | 0.41 |
| NAC Preterm Infants | 0.47 |
| NAC Term Infants | 0.38 |
NAC Total Body Clearance
(NCT00724594)
Timeframe: prior to delivery in mothers, and in newborn after delivery during 2 days of NAC infusion
| Intervention | mL/h/kg (Mean) |
|---|
| NAC Maternal | 255 |
| NAC Preterm Infants | 45.0 |
| NAC Term Infants | 53.7 |
NAC Terminal Elimination Half-life
(NCT00724594)
Timeframe: prior to delivery in mothers, and in newborn after delivery during 2 days of NAC infusion
| Intervention | hours (Mean) |
|---|
| NAC Maternal | 1.2 |
| NAC Preterm Infants | 7.5 |
| NAC Term Infants | 5.1 |
Maternal and Infant Mean Blood Pressure Change
(NCT00724594)
Timeframe: Maternal mean BP changes were pre/post dosing prior to delivery. Infant measurements were pre/post their first dosing
| Intervention | mmHg (Mean) |
|---|
| NAC Infants | -1.2 |
| Control Infants | 2.1 |
| NAC Maternal | 1 |
| Control Maternal | 2 |
Cytokine Level IL-1Ra in Plasma
anti-inflammatory cytokine Interleukin -1 Receptor alpha (IL-1Ra) (NCT00724594)
Timeframe: after N-acetylcysteine infusion
| Intervention | pg/ml (Median) |
|---|
| NAC Infants | 745 |
| Control Infants | 8.3 |
Cerebral Blood Flow
Resistive index in middle cerebral artery (MCA) (NCT00724594)
Timeframe: after NAC infusion
| Intervention | units on a scale (Mean) |
|---|
| NAC Term Infants | 0.93 |
| Control Term Infants | 0.89 |
| NAC Preterm Infants | 0.92 |
| Control Preterm Infants | 0.89 |
NAC Concentrations
(NCT00724594)
Timeframe: Peak: 30 minutes after NAC infusion. Cord: at delivery
| Intervention | micromol/L (Mean) |
|---|
| Peak NAC concentration in plasma | NAC cord concentration |
|---|
| NAC Maternal | 1222 | NA |
,| NAC Preterm Infants | 49.0 | 370.7 |
,| NAC Term Infants | 92.3 | 639.7 |
Magnetic Resonance Spectroscopy of Infants
ratio of myoInositol / NAA concentrations in basal ganglia (NCT00724594)
Timeframe: 36 - 40 weeks gestational age
| Intervention | ratio (Mean) |
|---|
| NAC Infants | 1.09 |
| Control Infants | 1.34 |
Number of Participants With Contrast-induced Nephropathy
Contrast-induced nephropathy was defined as an increase in serum creatinine level of greater than or equal to 0.5 mg/dL or an increase of 25% above baseline. The primary outcome was measured by the change in serum creatinine level from the pre-radiocontrast baseline to the serum creatinine level measured 48 to 72 hours after radiocontrast administration. (NCT00780962)
Timeframe: 48-72 hours
| Intervention | Participants (Count of Participants) |
|---|
| N-Acetycysteine Group | 14 |
| 0.9% Sodium-chloride Group | 12 |
FEF 25-75% (Percent of Predicted)
Difference in the forced expiratory flow rate in mid-exhalation as a percent of predicted to standard values measured from baseline to the end of study (24 weeks). (NCT00809094)
Timeframe: Baseline to 24 weeks
| Intervention | percent of predicted (Mean) |
|---|
| Study Drug | 1.33 |
| Placebo | -3.81 |
FEF 25-75% (L/Sec)
Difference in mid-expiratory flow rates between 25 to 75% of the vital capacity, in L/sec measured at the beginning of the study to the end of the study. (NCT00809094)
Timeframe: Baseline to end of study (24 weeks)
| Intervention | L/sec (Mean) |
|---|
| Study Drug | 0.08 |
| Placebo | -0.13 |
Change in the Logarithm of the Level of Human Neutrophil Elastase (HNE) Activity Measured in Sputum
(change in log10 HNE in the active treatment group) - (change in log10 HNE in the placebo group) (NCT00809094)
Timeframe: From enrollment to end of the 24-week trial
| Intervention | log10 mcg/mL (Log Mean) |
|---|
| Study Drug | 0.03 |
| Placebo | -0.17 |
Change in FEV1 (Percent of Predicted for Age)
Change in forced expiratory volume in 1 second as compared to normals for age (percent of predicted) (NCT00809094)
Timeframe: From enrollment to the end of the 24-week trial
| Intervention | percent of predicted vlaues (Number) |
|---|
| Study Drug | 1.055 |
| Placebo | -5.62 |
Change in ECHO Tricuspid Regurgitation (mm Hg) Over Time by Treatment Group
Change in measure of estimated right ventricular pressure over the 24-week study period (NCT00809094)
Timeframe: Baseline to 24 weeks
| Intervention | mm Hg (Mean) |
|---|
| Study Drug | 31.5 |
| Placebo | 31.75 |
Change in DLCO (ml/Min/mmHg) Over Time by Treatment Group
Change in the diffusing capacity of carbon monoxide across the lung measured from baseline to end of 24-week study. (NCT00809094)
Timeframe: Baseline to 24 weeks
| Intervention | ml/min/mm Hg (Mean) |
|---|
| Study Drug | -0.32 |
| Placebo | -1.39 |
FEV1 (L)
Forced expiratory volume in 1 second (Liters) (NCT00809094)
Timeframe: Baseline to end of study (24 weeks)
| Intervention | Liter (Number) |
|---|
| Study Drug | 2.5 |
| Placebo | -4.35 |
Fagerstrom Test for Nicotine Dependence Total Score
Week 12 corresponds to end of 6 sessions of N-acetylcysteine plus imaginal desensitization and motivational interviewing versus placebo plus imaginal desensitization and motivational interviewing. This scale has 6 questions. Questions 1 and 4 are on a scale from 0 to 3 (higher scores being more severe symptoms) and questions 2, 3, 5, and 6 are on a scale from 0 to 1 (1 being more severe symptoms). Scores on all questions are summed to compute total score, with higher total score meaning more severe nicotine dependence. Scores range from 0 to 10. (NCT00967005)
Timeframe: Week 12
| Intervention | units on a scale (Mean) |
|---|
| N Acetyl Cysteine | 5.3 |
| Sugar Pill | 5.0 |
Fagerstrom Test for Nicotine Dependence Total Score
Week 24 represents the 3-month follow-up period (ie, corresponds to being off N-acetylcysteine or placebo and done with imaginal desensitization and motivational interviewing for 12 weeks). This scale has 6 questions. Questions 1 and 4 are on a scale from 0 to 3 (higher scores being more severe symptoms) and questions 2, 3, 5, and 6 are on a scale from 0 to 1 (1 being more severe symptoms). Scores on all questions are summed to compute total score, with higher total score meaning more severe nicotine dependence. Scores range from 0 to 10. (NCT00967005)
Timeframe: Week 24
| Intervention | units on a scale (Mean) |
|---|
| N Acetyl Cysteine | 4.6 |
| Sugar Pill | 5.3 |
Fagerstrom Test for Nicotine Dependence Total Score
Week 6 corresponds to end of N-acetylcysteine plus Ask-Advise-Refer therapy versus placebo plus Ask-Advise-Refer therapy. This scale has 6 questions. Questions 1 and 4 are on a scale from 0 to 3 (higher scores being more severe symptoms) and questions 2, 3, 5, and 6 are on a scale from 0 to 1 (1 being more severe symptoms). Scores on all questions are summed to compute total score, with higher total score meaning more severe nicotine dependence. Scores range from 0 to 10. (NCT00967005)
Timeframe: Week 6
| Intervention | units on a scale (Mean) |
|---|
| N Acetyl Cysteine | 4.0 |
| Sugar Pill | 5.9 |
Hamilton Anxiety Rating Scale Total Score
Week 0 corresponds to baseline. This scale measures anxiety symptoms, tension, somatic symptoms, difficulty concentrating, and others. Total score is computed by summing the scores on the 14 items (each item is scored from 0 to 4). Minimum score= 0 and maximum score= 56, with higher scores signifying more severe anxiety symptoms. (NCT00967005)
Timeframe: Week 0
| Intervention | units on a scale (Mean) |
|---|
| N Acetyl Cysteine | 11.1 |
| Sugar Pill | 9.7 |
Hamilton Anxiety Rating Scale Total Score
Week 12 corresponds to end of 6 sessions of N-acetylcysteine plus imaginal desensitization and motivational interviewing versus placebo plus imaginal desensitization and motivational interviewing. This scale measures anxiety symptoms, tension, somatic symptoms, difficulty concentrating, and others. Total score is computed by summing the scores on the 14 items (each item is scored from 0 to 4). Minimum score= 0 and maximum score= 56, with higher scores signifying more severe anxiety symptoms. (NCT00967005)
Timeframe: Week 12
| Intervention | units on a scale (Mean) |
|---|
| N Acetyl Cysteine | 7.4 |
| Sugar Pill | 4.2 |
Hamilton Anxiety Rating Scale Total Score
Week 24 represents the 3-month follow-up period (ie, corresponds to being off N-acetylcysteine or placebo and done with imaginal desensitization and motivational interviewing for 12 weeks). This scale measures anxiety symptoms, tension, somatic symptoms, difficulty concentrating, and others. Total score is computed by summing the scores on the 14 items (each item is scored from 0 to 4). Minimum score= 0 and maximum score= 56, with higher scores signifying more severe anxiety symptoms. (NCT00967005)
Timeframe: Week 24
| Intervention | units on a scale (Mean) |
|---|
| N Acetyl Cysteine | 5.0 |
| Sugar Pill | 6.5 |
Hamilton Anxiety Rating Scale Total Score
Week 6 corresponds to end of N-acetylcysteine plus Ask-Advise-Refer therapy versus placebo plus Ask-Advise-Refer therapy. This scale measures anxiety symptoms, tension, somatic symptoms, difficulty concentrating, and others. Total score is computed by summing the scores on the 14 items (each item is scored from 0 to 4). Minimum score= 0 and maximum score= 56, with higher scores signifying more severe anxiety symptoms. (NCT00967005)
Timeframe: Week 6
| Intervention | units on a scale (Mean) |
|---|
| N Acetyl Cysteine | 7.5 |
| Sugar Pill | 6.2 |
Hamilton Depression Rating Scale Total Score
Week 12 corresponds to end of 6 sessions of N-acetylcysteine plus imaginal desensitization and motivational interviewing versus placebo plus imaginal desensitization and motivational interviewing. This scale assesses depressed mood, feelings of guilt, difficulty sleeping, somatic symptoms, and others. Total score is computed by summing the scores of the 17 items. Minimum score is 0 and maximum score is 52, with higher scores signifying more severe depressive symptoms. (NCT00967005)
Timeframe: Week 12
| Intervention | units on a scale (Mean) |
|---|
| N Acetyl Cysteine | 7.0 |
| Sugar Pill | 3.7 |
Hamilton Depression Rating Scale Total Score
Week 24 represents the 3-month follow-up period (ie, corresponds to being off N-acetylcysteine or placebo and done with imaginal desensitization and motivational interviewing for 12 weeks). This scale assesses depressed mood, feelings of guilt, difficulty sleeping, somatic symptoms, and others. Total score is computed by summing the scores of the 17 items. Minimum score is 0 and maximum score is 52, with higher scores signifying more severe depressive symptoms. (NCT00967005)
Timeframe: Week 24
| Intervention | units on a scale (Mean) |
|---|
| N Acetyl Cysteine | 2.8 |
| Sugar Pill | 3.5 |
Hamilton Depression Rating Scale Total Score
Week 6 corresponds to end of N-acetylcysteine plus Ask-Advise-Refer therapy versus placebo plus Ask-Advise-Refer therapy. This scale assesses depressed mood, feelings of guilt, difficulty sleeping, somatic symptoms, and others. Total score is computed by summing the scores of the 17 items. Minimum score is 0 and maximum score is 52, with higher scores signifying more severe depressive symptoms. (NCT00967005)
Timeframe: Week 6
| Intervention | units on a scale (Mean) |
|---|
| N Acetyl Cysteine | 7.5 |
| Sugar Pill | 5.5 |
Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Behavior Subscale
Week 0 corresponds to baseline. Questions 6 through 10 are summed to compute the thoughts/urges subscale. Minimum=0 and maximum=20, with higher scores signifying more severe gambling behaviors. (NCT00967005)
Timeframe: Week 0
| Intervention | units on a scale (Mean) |
|---|
| N Acetyl Cysteine | 11.7 |
| Sugar Pill | 11.4 |
Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Behavior Subscale
Week 12 corresponds to end of 6 sessions of N-acetylcysteine plus imaginal desensitization and motivational interviewing versus placebo plus imaginal desensitization and motivational interviewing. Questions 6 through 10 are summed to compute the thoughts/urges subscale. Minimum=0 and maximum=20, with higher scores signifying more severe gambling behaviors. (NCT00967005)
Timeframe: Week 12
| Intervention | units on a scale (Mean) |
|---|
| N Acetyl Cysteine | 2.0 |
| Sugar Pill | 2.8 |
Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Behavior Subscale
Week 24 represents the 3-month follow-up period (ie, corresponds to being off N-acetylcysteine or placebo and done with imaginal desensitization and motivational interviewing for 12 weeks). Questions 6 through 10 are summed to compute the thoughts/urges subscale. Minimum=0 and maximum=20, with higher scores signifying more severe gambling behaviors. (NCT00967005)
Timeframe: Week 24
| Intervention | units on a scale (Mean) |
|---|
| N Acetyl Cysteine | 0.2 |
| Sugar Pill | 2.8 |
Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Behavior Subscale
Week 6 corresponds to end of N-acetylcysteine plus Ask-Advise-Refer therapy versus placebo plus Ask-Advise-Refer therapy. . Questions 6 through 10 are summed to compute the thoughts/urges subscale. Minimum=0 and maximum=20, with higher scores signifying more severe gambling behaviors. (NCT00967005)
Timeframe: Week 6
| Intervention | units on a scale (Mean) |
|---|
| N Acetyl Cysteine | 8.5 |
| Sugar Pill | 8.3 |
Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Total Score
Week 0 corresponds to baseline. Minimum score=0 and maximum score=40, with higher score signifying more severe symptoms. Scale is 10 items scored from 0 to 4. Scores on each item are summed to compute total score. Thoughts/urges (questions 1 to 5) and behavior (questions 6 to 10) are added to get the total score. (NCT00967005)
Timeframe: Week 0
| Intervention | units on a scale (Mean) |
|---|
| N Acetyl Cysteine | 23.5 |
| Sugar Pill | 20.4 |
Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Total Score
Week 12 corresponds to end of 6 sessions of N-acetylcysteine plus imaginal desensitization and motivational interviewing versus placebo plus imaginal desensitization and motivational interviewing. Minimum score=0 and maximum score=40, with higher score signifying more severe symptoms. Scale is 10 items scored from 0 to 4. Scores on each item are summed to compute total score. Thoughts/urges (questions 1 to 5) and behavior (questions 6 to 10) are added to get the total score. (NCT00967005)
Timeframe: Week 12
| Intervention | units on a scale (Mean) |
|---|
| N Acetyl Cysteine | 7.5 |
| Sugar Pill | 5.5 |
Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Total Score
Week 24 represents the 3-month follow-up period (ie, corresponds to being off N-acetylcysteine or placebo and done with imaginal desensitization and motivational interviewing for 12 weeks). Minimum score=0 and maximum score=40, with higher score signifying more severe symptoms. Scale is 10 items scored from 0 to 4. Scores on each item are summed to compute total score. Thoughts/urges (questions 1 to 5) and behavior (questions 6 to 10) are added to get the total score. (NCT00967005)
Timeframe: Week 24
| Intervention | units on a scale (Mean) |
|---|
| N Acetyl Cysteine | 1.0 |
| Sugar Pill | 6.4 |
Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Total Score
Week 6 corresponds to end of N-acetylcysteine plus Ask-Advise-Refer therapy versus placebo plus Ask-Advise-Refer therapy. Minimum score=0 and maximum score=40, with higher score signifying more severe symptoms. Scale is 10 items scored from 0 to 4. Scores on each item are summed to compute total score. Thoughts/urges (questions 1 to 5) and behavior (questions 6 to 10) are added to get the total score. (NCT00967005)
Timeframe: Week 6
| Intervention | units on a scale (Mean) |
|---|
| N Acetyl Cysteine | 17.4 |
| Sugar Pill | 16.3 |
Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Urges/Thoughts Subscale
Week 12 corresponds to end of 6 sessions of N-acetylcysteine plus imaginal desensitization and motivational interviewing versus placebo plus imaginal desensitization and motivational interviewing. Questions 1 through 5 are summed to compute the thoughts/urges subscale. Minimum=0 and maximum=20, with higher scores signifying more severe thoughts/urges. (NCT00967005)
Timeframe: Week 12
| Intervention | units on a scale (Mean) |
|---|
| N Acetyl Cysteine | 5.5 |
| Sugar Pill | 2.7 |
Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Urges/Thoughts Subscale
Week 24 represents the 3-month follow-up period (ie, corresponds to being off N-acetylcysteine or placebo and done with imaginal desensitization and motivational interviewing for 12 weeks). Questions 1 through 5 are summed to compute the thoughts/urges subscale. Minimum=0 and maximum=20, with higher scores signifying more severe thoughts/urges. (NCT00967005)
Timeframe: Week 24
| Intervention | units on a scale (Mean) |
|---|
| N Acetyl Cysteine | 0.8 |
| Sugar Pill | 3.6 |
Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Urges/Thoughts Subscale
Week 6 corresponds to end of N-acetylcysteine plus Ask-Advise-Refer therapy versus placebo plus Ask-Advise-Refer therapy. Questions 1 through 5 are summed to compute the thoughts/urges subscale. Minimum=0 and maximum=20, with higher scores signifying more severe thoughts/urges. (NCT00967005)
Timeframe: Week 6
| Intervention | units on a scale (Mean) |
|---|
| N Acetyl Cysteine | 8.9 |
| Sugar Pill | 7.9 |
Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Urges/Thoughts Subscale
Week 0 corresponds to baseline. Questions 1 through 5 are summed to compute the thoughts/urges subscale. Minimum=0 and maximum=20, with higher scores signifying more severe thoughts/urges. (NCT00967005)
Timeframe: Week 0
| Intervention | units on a scale (Mean) |
|---|
| N Acetyl Cysteine | 11.8 |
| Sugar Pill | 9.0 |
Hamilton Depression Rating Scale Total Score
Week 0 corresponds to baseline. This scale assesses depressed mood, feelings of guilt, difficulty sleeping, somatic symptoms, and others. Total score is computed by summing the scores of the 17 items. Minimum score is 0 and maximum score is 52, with higher scores signifying more severe depressive symptoms. (NCT00967005)
Timeframe: Week 0
| Intervention | units on a scale (Mean) |
|---|
| N Acetyl Cysteine | 9.7 |
| Sugar Pill | 7.9 |
Fagerstrom Test for Nicotine Dependence Total Score
Week 0 corresponds to baseline. This scale has 6 questions. Questions 1 and 4 are on a scale from 0 to 3 (higher scores being more severe symptoms) and questions 2, 3, 5, and 6 are on a scale from 0 to 1 (1 being more severe symptoms). Scores on all questions are summed to compute total score, with higher total score meaning more severe nicotine dependence. Scores range from 0 to 10. (NCT00967005)
Timeframe: Week 0
| Intervention | units on a scale (Mean) |
|---|
| N Acetyl Cysteine | 6.5 |
| Sugar Pill | 6.7 |
Oxysterol Levels
(NCT00975689)
Timeframe: Six months
| Intervention | ng/mL (Mean) |
|---|
| NAC Phase | 28.09 |
| Placebo Phase | 27.64 |
Massachusetts General Hospital Hair Pulling Scale (MGH-HPS)
The Massachusetts General Hospital - Hairpulling Scale (MGH-HPS) is a 7-question scale that measures the severity of hair pulling. The scale ranges from 0-28. The higher the score, the more severe the hairpulling. (NCT00993265)
Timeframe: Week 12
| Intervention | units on a scale (Mean) |
|---|
| N-acetylcysteine (NAC) | 10.70 |
| Placebo | 13.53 |
Multidimensional Anxiety Scale for Children (MASC)
The Multidimensional Anxiety Scale for Children (MASC) assesses major dimensions of anxiety in children. The MASC contains 39 items rated on a scale of 0-3. Scores range from 0-117. The higher the score, the greater the anxiety. (NCT00993265)
Timeframe: Week 12
| Intervention | units on a scale (Mean) |
|---|
| N-acetylcysteine (NAC) | 48.4 |
| Placebo | 49.8 |
Children's Depression Inventory
The Massachusetts General Hospital - Hairpulling Scale (MGH-HPS) is a 7-question scale that measures the severity of hair pulling. The scale ranges from 0-28. The higher the score, the more severe the hairpulling. (NCT00993265)
Timeframe: Week 12
| Intervention | units on a scale (Mean) |
|---|
| N-acetylcysteine (NAC) | 10.9 |
| Placebo | 7.8 |
The Milwaukee Inventory for Styles of Trichotillomania-Child Version
"The Milwaukee Inventory for Styles of Trichotillomania (MIST) - Child Version assesses focused pulling, hair pulling that occurs intentionally to relieve tension or distress, and automatic pulling, hair pulling that occurs outside of the child's attention. This scale contains 25 questions, 21 questions in the focused pulling subscale and 4 questions in the automatic pulling subscale. The scores range from 0-36 on the automatic pulling subscale and 0-189 on the focused pulling subscale. Higher scores on the subscales indicate more of the hair pulling is of that style." (NCT00993265)
Timeframe: Week 12
| Intervention | units on a scale (Mean) |
|---|
| "Week 12 MIST-C Automatic Subscale" | "Week 12 MIST-C Focused Subscale" |
|---|
| N-acetylcysteine (NAC) | 13.24 | 90.8 |
,| Placebo | 13.16 | 79.6 |
Trichotillomania Scale for Children - Parent Version
The Trichotillomania Scale for Children (TSC) - Parent Version assesses hair pulling severity, distress, and impairment in children. The scale is split into two sections (severity and distress/impairment), with 12 questions (5 severity and 7 distress/impairment). The severity score is summed from questions 1-5 and divided by 5. The distress/impairment score is summed from questions 6-12 and divided by 7. The total score is calculated by summing the severity score and the distress/impairment score. Scores range from 0-4. Higher total scores indicate greater severity/distress/impairment. (NCT00993265)
Timeframe: Week 12
| Intervention | units on a scale (Mean) |
|---|
| N-acetylcysteine (NAC) | 1.83 |
| Placebo | 1.88 |
Trichotillomania Scale for Children - Child Version
The Trichotillomania Scale for Children (TSC) - Child Version assesses hair pulling severity, distress, and impairment in children. The scale is split into two sections (severity and distress/impairment), with 12 questions (5 severity and 7 distress/impairment). The severity score is summed from questions 1-5 and divided by 5. The distress/impairment score is summed from questions 6-12 and divided by 7. The total score is calculated by summing the severity score and the distress/impairment score. Scores range from 0-4. Higher total scores indicate greater severity/distress/impairment. (NCT00993265)
Timeframe: Week 12
| Intervention | units on a scale (Mean) |
|---|
| N-acetylcysteine (NAC) | 2.00 |
| Placebo | 2.08 |
National Institute of Mental Health -Trichotillomania Severity Scale (NIMH-TSS)
The National Institute of Mental Health - Trichotillomania Severity Scale (NIMH-TSS) assesses severity of hair pulling. The NIMH-TSS is a 6 item assessment, with total scores ranging from 0-20. Higher scores indicate greater severity/impairment. (NCT00993265)
Timeframe: Week 12
| Intervention | units on a scale (Mean) |
|---|
| N-acetylcysteine (NAC) | 9.56 |
| Placebo | 10.89 |
Percentage of Negative Urine Cannabinoid Tests During Treatment
[Total number of negative urine tests per Group divided by the total number of urine tests per Group]*100 (NCT01005810)
Timeframe: weekly during treatment, for 8 weeks
| Intervention | percentage of negative urine tests (Number) |
|---|
| N-Acetylcysteine | 40.9 |
| Placebo | 27.2 |
Yale Brown Obsessive Compulsive Scale (YBOCS) Modified for PSP (NE-YBOCS)
"The entire study for an individual subject will last 12 weeks. Every 3 weeks the subject will take the YBOCS for the duration of the 12 weeks. At each of these visits the outcome will be assessed.~The minimum score is 0 and the maximum score is 40, with a higher score being more severe skin picking. There are two sub-scales: one for urges (ranges from 0 to 20) and one for behaviors (ranges from 0 to 20). The total of the scores of each of the sub-scales is the total YBOCS score. That is what will be reported." (NCT01063348)
Timeframe: Once every three weeks during the 12 week study for each subject
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Week 3 | Week 6 | Week 9 | Week 12 |
|---|
| N-Acetyl Cysteine | 18.8 | 16.1 | 13.9 | 12.4 | 11.5 |
,| Placebo | 17.6 | 17.3 | 16.3 | 15.0 | 14.1 |
Skin Picking Self Assessment Scale (SP-SAS)
"The entire study for an individual subject will last 12 weeks. Every 3 weeks the subject will take the YBOCS for the duration of the 12 weeks. At each of these visits the outcome will be assessed.~The minimum score is 0 and the maximum score is 48 with higher scores meaning more severe skin picking. The total of all of the questions equals the total reported SP-SAS score." (NCT01063348)
Timeframe: Once every three weeks for the duration of the 12 week study for each subject
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Week 3 | Week 6 | Week 9 | Week 12 |
|---|
| N-Acetyl Cysteine | 28.6 | 24.8 | 21.9 | 21.5 | 19.4 |
,| Placebo | 28.6 | 25.5 | 25.0 | 24.2 | 24.5 |
To Evaluate the Incidence of Treatment Emergent Adverse Events
(NCT01118663)
Timeframe: 21-42 hours
| Intervention | Number of Events (Number) |
|---|
| Acetadote Without EDTA | 13 |
| Acetadote | 14 |
To Evaluate the Incidence of Anaphylactoid Reaction.
Data analysis was conducted on the subjects enrolled in the study prior to study termination. Because the study was terminated prematurely due to lack of enrollment, there was an insufficient sample size to conduct an efficacy analysis. (NCT01118663)
Timeframe: 1 hour
| Intervention | participants (Number) |
|---|
| Acetadote Without EDTA | 0 |
| Acetadote | 1 |
OCD Severity at 12 Weeks
Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) (0-7:Subclinical, 8-15: Mild, 16-23: Moderate, 24-31: Severe, 32-40: Extreme) (NCT01172275)
Timeframe: 12 weeks
| Intervention | points on a scale (Mean) |
|---|
| N-Acetylcysteine | 21.4 |
| Placebo | 21.3 |
Overall Improvement at 12 Weeks
"Clinician Global Improvement Scale (CGI) 0=Not assessed 4=Moderately ill~Normal, not at all ill 5=Markedly ill~Borderline mentally ill 6=Severly ill~Mildly ill 7=Very much worse" (NCT01172275)
Timeframe: 12 weeks
| Intervention | score on a scale (Mean) |
|---|
| N-Acetylcysteine | 3.2 |
| Placebo | 3.5 |
Overall Improvement
Clinical Global Impression - Improvement Scale (CGI-I). The CGI is a 7-point scare that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. 1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 = Minimally worse; 6 = Much worse; 7 = Very much worse. (NCT01172288)
Timeframe: 12 weeks
| Intervention | units on a scale (Mean) |
|---|
| N-Acetylcysteine | 3.3 |
| Placebo | 3.4 |
Number of Participants With Adverse Effects
Number of participants with adverse events according to the Pediatric Adverse Events Rating Scale (NCT01172288)
Timeframe: 12 weeks
| Intervention | participants (Number) |
|---|
| Irritability | Sadness or depressed mood | Fatigue | Insomnia | Decreased appetite | Chest pain | Syncope | Stomach ache | Nausea | Vomiting | Headache |
|---|
| N-Acetylcysteine | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
,| Placebo | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 2 | 3 | 0 | 1 |
Improvement of Premonitory Urges
"Premonitory Urge for Tics Scale (PUTS). Items are rated on a scale of 1-4 from least to most. A total score is calculated by summing the scores of all items. Nine is the minimum possible score. A score of 12.5-24.5 indicates medium intensity of premonitory urges for tics. A score of 25-30.5 indicates high intensity which may be associated with marked impairment. Scores 31 and above indicate extremely high intensity with probable severe impairment. A score of 36 is the maximum score possible." (NCT01172288)
Timeframe: 12 weeks
| Intervention | units on a scale (Mean) |
|---|
| N-Acetylcysteine | 24.7 |
| Placebo | 24.1 |
Improvement in Tic Severity
"Yale Global Tic Severity Scale is a standard psychiatric measure that rates tics from 0 (no tics) to 100 (most severe tics).~It separately rates motor tics and vocal tics in 5 subscales (number, frequency, intensity, complexity and interference) where the maximum severity score for motor tics is 25 and for vocal tics is 25. Giving us the Total Tic Severity Score maximum of 50.~The additional Impairment Scale rates the degree of disability caused by the tics ranging from 0 (none) to 50 (severe). When these two scores are added we get the Yale Global Tic Severity Scale Score." (NCT01172288)
Timeframe: 12 weeks
| Intervention | units on a scale (Mean) |
|---|
| N-Acetylcysteine | 24.3 |
| Placebo | 21.3 |
Improvement in OCD Severity
Childrens' Yale-Brown Obsessive-Compulsive Scale (CY-BOCS). 10-item scale. Each item is rated from 0-4. A sum total is calculated by adding items 1-10. 0-7: Subclinical. 8-15: Mild. 16-23: Moderate. 24-31: Severe. 32-40: Extreme. (NCT01172288)
Timeframe: 12 weeks
| Intervention | units on a scale (Mean) |
|---|
| N-Acetylcysteine | 4.4 |
| Placebo | 11.5 |
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
The Quality of Life Enjoyment and Satisfaction Questionnaire is designed to assess a quality of life. The scale has a total score range of 16-80. Higher values represent a better outcome (i.e., better quality of life). (NCT01214083)
Timeframe: week 1 and week 13
| Intervention | units on a scale (Mean) |
|---|
| Q-LES-Q at week 1 | Q-LES-Q at week 13 |
|---|
| High-dose Naltrexone (150 mg) Alone | 53.8 | 59.6 |
,| Low-dose Naltrexone (50 mg) Alone | 55.1 | 63.9 |
,| N-acetylcysteine + High-dose Naltrexone (150 mg) | 53.2 | 61.6 |
Percentage of Heavy Drinking Days
"Percentage of heavy drinking days was measured by the Time Line Follow Back (TLFB) Method. ('Heavy drinking' was defined as 5 or more standard drinks per day for men and 4 or more standard drinks for women.) The percentage has a total range of 0%-100%. Higher percentages represent a worse outcome (i.e., more heavy drinking)." (NCT01214083)
Timeframe: week 1 and week 13
| Intervention | percentage of heavy drinking days (Mean) |
|---|
| Percentage of heavy drinking days at week 1 | Percentage of heavy drinking days at week 13 |
|---|
| High-dose Naltrexone (150 mg) Alone | 50.6 | 3.4 |
,| Low-dose Naltrexone (50 mg) Alone | 44.0 | 3.3 |
,| N-acetylcysteine + High-dose Naltrexone (150 mg) | 45.0 | 5.2 |
Percentage of Drinking Days
"Percentage of drinking days was measured by the Time Line Follow Back (TLFB) Method. The percentage has a total range of 0%-100%. Higher percentages represent a worse outcome (i.e., more drinking days)." (NCT01214083)
Timeframe: week 1 and week 13
| Intervention | percentage of drinking days (Mean) |
|---|
| percentage of drinking days at week 1 | percentage of drinking days at week 13 |
|---|
| High-dose Naltrexone (150 mg) Alone | 63.8 | 24.5 |
,| Low-dose Naltrexone (50 mg) Alone | 55.3 | 18.2 |
,| N-acetylcysteine + High-dose Naltrexone (150 mg) | 64.6 | 21.1 |
Liver Function Tests (AST)
(NCT01214083)
Timeframe: week 0 and week 13
| Intervention | units/liter (Mean) |
|---|
| Liver function tests (AST) at week 0 | Liver function tests (AST) at week 13 |
|---|
| High-dose Naltrexone (150 mg) Alone | 29.0 | 32.1 |
,| Low-dose Naltrexone (50 mg) Alone | 30.0 | 22.2 |
,| N-acetylcysteine + High-dose Naltrexone (150 mg) | 34.7 | 27.3 |
Penn Alcohol Craving Scale (PACS)
The Penn Alcohol Craving Scale is designed to assess alcohol craving severity. The scale has a total score range of 0-30. Higher values represent a worse outcome (i.e., higher craving). (NCT01214083)
Timeframe: week 1 and week 13
| Intervention | units on a scale (Mean) |
|---|
| Penn Alcohol Craving Scale at week 1 | Penn Alcohol Craving Scale at week 13 |
|---|
| High-dose Naltrexone (150 mg) Alone | 18.4 | 8.3 |
,| Low-dose Naltrexone (50 mg) Alone | 16.1 | 6.3 |
,| N-acetylcysteine + High-dose Naltrexone (150 mg) | 18.0 | 7.2 |
Clinical Global Impression (CGI)
The Clinical Global Impression is designed to assess overall severity of illness. The scale has a total score range of 1-7. Higher values represent a worse outcome (i.e., severe illness). (NCT01214083)
Timeframe: week 1 and week 13
| Intervention | units on a scale (Mean) |
|---|
| Clinical Global Impression at week 1 | Clinical Global Impression at week 13 |
|---|
| High-dose Naltrexone (150 mg) Alone | 3.7 | 1.7 |
,| Low-dose Naltrexone (50 mg) Alone | 3.6 | 1.4 |
,| N-acetylcysteine + High-dose Naltrexone (150 mg) | 3.7 | 1.5 |
Drinks Per Drinking Days
(NCT01214083)
Timeframe: week 1 and week 13
| Intervention | drinks/drinking day (Mean) |
|---|
| drinks per drinking days at week 1 | drinks per drinking days at week 13 |
|---|
| High-dose Naltrexone (150 mg) Alone | 5.9 | 1.2 |
,| Low-dose Naltrexone (50 mg) Alone | 7.3 | 1.0 |
,| N-acetylcysteine + High-dose Naltrexone (150 mg) | 7.3 | 1.1 |
Obsessive Compulsive Drinking Scale (OCDS)
The Obsessive Compulsive Drinking Scale is designed to assess obsessive and compulsive aspects of alcoholism. The scale has a total score range of 0-56. Higher values represent a worse outcome (i.e., more alcohol problems). (NCT01214083)
Timeframe: week 1 and week 13
| Intervention | units on a scale (Mean) |
|---|
| Obsessive Compulsive Drinking Scale at week 1 | Obsessive Compulsive Drinking Scale at week 13 |
|---|
| High-dose Naltrexone (150 mg) Alone | 29.0 | 14.0 |
,| Low-dose Naltrexone (50 mg) Alone | 24.5 | 9.0 |
,| N-acetylcysteine + High-dose Naltrexone (150 mg) | 28.2 | 9.1 |
Liver Function Tests (ALT)
(NCT01214083)
Timeframe: week 0 and week 13
| Intervention | units/liter (Mean) |
|---|
| Liver Function Tests (ALT) at week 0 | Liver Function Tests (ALT) at week 13 |
|---|
| High-dose Naltrexone (150 mg) Alone | 36.5 | 40.1 |
,| Low-dose Naltrexone (50 mg) Alone | 34.7 | 31.3 |
,| N-acetylcysteine + High-dose Naltrexone (150 mg) | 49.4 | 27.6 |
BACS Composite RAW Score
"The Brief Assessment of Cognition in Schizophrenia (BACS) is an instrument that assesses the aspects of cognition found to be most impaired and most strongly correlated with outcome in patients with schizophrenia.~The BACS composite raw score the total of the raw scores for the 6 subtests of the BACS (Verbal memory, token motor, digit sequencing, verbal fluency, symbol coding and executive functioning). The range, so we could be from 0-435. A high score total score is more favorable and indicates a higher level of cognition.~The BACS requires less than 35 min to complete in patients with schizophrenia, yields a high completion rate in these patients, and has high reliability. The BACS was found to be as sensitive to cognitive impairment in patients with schizophrenia as a standard battery of tests that required over 2 h to administer. It is the raw sum of the test items and higher scores are favorable." (NCT01232790)
Timeframe: Baseline
| Intervention | units on a scale (Mean) |
|---|
| Intervention | 229.04 |
| Placebo | 227.83 |
Letter/Number Sequencing Task Tests for Attention, Concentration & Mental Control (LNS) RAW SCORE.
Letter Number Sequencing (LNS) is a brief, standardized executive function task used to assess verbal working memory performance. The test involves a 24-item Experimental Condition, in which participants are read a series of letters and numbers and asked to recite both back in ascending order, with the numbers first and then the letters. Participants receive one point for each correct answer for a range of 0-24. Higher scores are better. (NCT01232790)
Timeframe: Follow Up 2nd Leg of Crossover (5 Days)
| Intervention | units on a scale (Mean) |
|---|
| Group A: NAC 1st Trial, Placebo 2nd Trial | 14.27 |
| Group B: Placebo 1st Trial, NAC 2nd Trial | 14.44 |
Letter/Number Sequencing Task Tests for Attention, Concentration & Mental Control (LNS) RAW SCORE.
Letter Number Sequencing (LNS) is a brief, standardized executive function task used to assess verbal working memory performance. The test involves a 24-item Experimental Condition, in which participants are read a series of letters and numbers and asked to recite both back in ascending order, with the numbers first and then the letters. Participants receive one point for each correct answer for a range of 0-24. Higher scores are better. (NCT01232790)
Timeframe: Follow Up 1st Leg of Crossover (5 Days)
| Intervention | units on a scale (Mean) |
|---|
| Group A: NAC 1st Trial, Placebo 2nd Trial | 12.75 |
| Group B: Placebo 1st Trial, NAC 2nd Trial | 13.36 |
Letter/Number Sequencing Task Tests for Attention, Concentration & Mental Control (LNS) RAW SCORE.
Letter Number Sequencing (LNS) is a brief, standardized executive function task used to assess verbal working memory performance. The test involves a 24-item Experimental Condition, in which participants are read a series of letters and numbers and asked to recite both back in ascending order, with the numbers first and then the letters. Participants receive one point for each correct answer for a range of 0-24. Higher scores are better. (NCT01232790)
Timeframe: Follow Up (5 days)
| Intervention | units on a scale (Mean) |
|---|
| Intervention | 13.48 |
| Placebo | 13.81 |
Letter/Number Sequencing Task Tests for Attention, Concentration & Mental Control (LNS) RAW SCORE.
Letter Number Sequencing (LNS) is a brief, standardized executive function task used to assess verbal working memory performance. The test involves a 24-item Experimental Condition, in which participants are read a series of letters and numbers and asked to recite both back in ascending order, with the numbers first and then the letters. Participants receive one point for each correct answer for a range of 0-24. Higher scores are better. (NCT01232790)
Timeframe: Change from Baseline at Follow Up (5 days)
| Intervention | units on a scale (Mean) |
|---|
| Intervention | 0.14 |
| Placebo | -0.45 |
Letter/Number Sequencing Task Tests for Attention, Concentration & Mental Control (LNS) RAW SCORE.
Letter Number Sequencing (LNS) is a brief, standardized executive function task used to assess verbal working memory performance. The test involves a 24-item Experimental Condition, in which participants are read a series of letters and numbers and asked to recite both back in ascending order, with the numbers first and then the letters. Participants receive one point for each correct answer for a range of 0-24. Higher scores are better. (NCT01232790)
Timeframe: Baseline
| Intervention | units on a scale (Mean) |
|---|
| Intervention | 13.43 |
| Placebo | 13.22 |
BACS Composite RAW Score
"The Brief Assessment of Cognition in Schizophrenia (BACS) is an instrument that assesses the aspects of cognition found to be most impaired and most strongly correlated with outcome in patients with schizophrenia.~The BACS composite raw score the total of the raw scores for the 6 subtests of the BACS (Verbal memory, token motor, digit sequencing, verbal fluency, symbol coding and executive functioning). The range, so we could be from 0-435. A high score total score is more favorable and indicates a higher level of cognition.~The BACS requires less than 35 min to complete in patients with schizophrenia, yields a high completion rate in these patients, and has high reliability. The BACS was found to be as sensitive to cognitive impairment in patients with schizophrenia as a standard battery of tests that required over 2 h to administer. It is the raw sum of the test items and higher scores are favorable." (NCT01232790)
Timeframe: Change from Baseline at Follow Up (5 days)
| Intervention | units on a scale (Mean) |
|---|
| Intervention | -7.00 |
| Placebo | -5.59 |
BACS Composite RAW Score
"The Brief Assessment of Cognition in Schizophrenia (BACS) is an instrument that assesses the aspects of cognition found to be most impaired and most strongly correlated with outcome in patients with schizophrenia.~The BACS composite raw score the total of the raw scores for the 6 subtests of the BACS (Verbal memory, token motor, digit sequencing, verbal fluency, symbol coding and executive functioning). The range, so we could be from 0-435. A high score total score is more favorable and indicates a higher level of cognition.~The BACS requires less than 35 min to complete in patients with schizophrenia, yields a high completion rate in these patients, and has high reliability. The BACS was found to be as sensitive to cognitive impairment in patients with schizophrenia as a standard battery of tests that required over 2 h to administer. It is the raw sum of the test items and higher scores are favorable." (NCT01232790)
Timeframe: Follow Up (5 days)
| Intervention | units on a scale (Mean) |
|---|
| Intervention | 234.90 |
| Placebo | 237.77 |
BACS Composite RAW Score
"The Brief Assessment of Cognition in Schizophrenia (BACS) is an instrument that assesses the aspects of cognition found to be most impaired and most strongly correlated with outcome in patients with schizophrenia.~The BACS composite raw score the total of the raw scores for the 6 subtests of the BACS (Verbal memory, token motor, digit sequencing, verbal fluency, symbol coding and executive functioning). The range, so we could be from 0-435. A high score total score is more favorable and indicates a higher level of cognition.~The BACS requires less than 35 min to complete in patients with schizophrenia, yields a high completion rate in these patients, and has high reliability. The BACS was found to be as sensitive to cognitive impairment in patients with schizophrenia as a standard battery of tests that required over 2 h to administer. It is the raw sum of the test items and higher scores are favorable." (NCT01232790)
Timeframe: Follow Up 2nd Leg of Crossover (5 Days)
| Intervention | units on a scale (Mean) |
|---|
| Group A: NAC 1st Trial, Placebo 2nd Trial | 238.55 |
| Group B: Placebo 1st Trial, NAC 2nd Trial | 239.33 |
Brief Psychiatric Rating Scale (BPRS)Total Score
"Brief Psychiatric Rating Scale (BPRS) utilized before and after treatment. BPRS total score is a total of the 18 item scores with a range of 18-126. It is used to measure schizophrenia symptoms and to assess change in them over time. There are 18 symptom sub scores. Each symptom is rated 1-7 (not present to extremely severe) and then all items are summed for the total score. Higher scores indicate more severe symptoms.~The BPRS is the gold-standard overall measure of schizophrenia symptoms which will be utilized to demonstrate that the intervention does not cause worsening of the illness symptoms apart from the usual fluctuations of the natural course." (NCT01232790)
Timeframe: Change from PreScreening at End of Trial
| Intervention | units on a scale (Mean) |
|---|
| Group A: NAC 1st Trial, Placebo 2nd Trial | 1.70 |
| Group B: Placebo 1st Trial, NAC 2nd Trial | 0.89 |
Brief Psychiatric Rating Scale (BPRS)Total Score
"Brief Psychiatric Rating Scale (BPRS) utilized before and after treatment. BPRS total score is a total of the 18 item scores with a range of 18-126. It is used to measure schizophrenia symptoms and to assess change in them over time. There are 18 symptom sub scores. Each symptom is rated 1-7 (not present to extremely severe) and then all items are summed for the total score. Higher scores indicate more severe symptoms.~The BPRS is the gold-standard overall measure of schizophrenia symptoms which will be utilized to demonstrate that the intervention does not cause worsening of the illness symptoms apart from the usual fluctuations of the natural course." (NCT01232790)
Timeframe: End of Trial
| Intervention | units on a scale (Mean) |
|---|
| Group A: NAC 1st Trial, Placebo 2nd Trial | 32.80 |
| Group B: Placebo 1st Trial, NAC 2nd Trial | 27.78 |
Brief Psychiatric Rating Scale (BPRS)Total Score
"Brief Psychiatric Rating Scale (BPRS) utilized before and after treatment. BPRS total score is a total of the 18 item scores with a range of 18-126. It is used to measure schizophrenia symptoms and to assess change in them over time. There are 18 symptom sub scores. Each symptom is rated 1-7 (not present to extremely severe) and then all items are summed for the total score. Higher scores indicate more severe symptoms.~The BPRS is the gold-standard overall measure of schizophrenia symptoms which will be utilized to demonstrate that the intervention does not cause worsening of the illness symptoms apart from the usual fluctuations of the natural course." (NCT01232790)
Timeframe: Pre Screening
| Intervention | units on a scale (Mean) |
|---|
| Group A: NAC 1st Trial, Placebo 2nd Trial | 30.92 |
| Group B: Placebo 1st Trial, NAC 2nd Trial | 28.41 |
Brief Visuospatial Memory Test (BVMT) RAW SCORE.
Brief Visuospatial Memory Test (BVMT) is a measure of visuospatial memory. This task includes three trials of six geometric figures printed in a 2 x 3 array on separate pages. The respondent views the stimulus page for 10 seconds and is asked to draw as many of the figures as possible in their correct location on a page in the response booklet. A Delayed Recall Trial is administered after a 25-minute delay. Scoring is based on accuracy of the figure as well as its location on the page. A range of 0-12 per trial is possible(0-36 total). Higher scores are better. (NCT01232790)
Timeframe: Follow Up 1st Leg of Crossover (5 Days)
| Intervention | units on a scale (Mean) |
|---|
| Group A: NAC 1st Trial, Placebo 2nd Trial | 16.55 |
| Group B: Placebo 1st Trial, NAC 2nd Trial | 18.25 |
Letter/Number Sequencing Task Tests for Attention, Concentration & Mental Control (LNS) RAW SCORE.
Letter Number Sequencing (LNS) is a brief, standardized executive function task used to assess verbal working memory performance. The test involves a 24-item Experimental Condition, in which participants are read a series of letters and numbers and asked to recite both back in ascending order, with the numbers first and then the letters. Participants receive one point for each correct answer for a range of 0-24. Higher scores are better. (NCT01232790)
Timeframe: Baseline 2nd Leg of Crossover
| Intervention | units on a scale (Mean) |
|---|
| Group A: NAC 1st Trial, Placebo 2nd Trial | 13.42 |
| Group B: Placebo 1st Trial, NAC 2nd Trial | 13.55 |
Letter/Number Sequencing Task Tests for Attention, Concentration & Mental Control (LNS) RAW SCORE.
Letter Number Sequencing (LNS) is a brief, standardized executive function task used to assess verbal working memory performance. The test involves a 24-item Experimental Condition, in which participants are read a series of letters and numbers and asked to recite both back in ascending order, with the numbers first and then the letters. Participants receive one point for each correct answer for a range of 0-24. Higher scores are better. (NCT01232790)
Timeframe: Baseline 1st Leg of Crossover
| Intervention | units on a scale (Mean) |
|---|
| Group A: NAC 1st Trial, Placebo 2nd Trial | 13.33 |
| Group B: Placebo 1st Trial, NAC 2nd Trial | 13.00 |
Brief Visuospatial Memory Test (BVMT) RAW SCORE.
Brief Visuospatial Memory Test (BVMT) is a measure of visuospatial memory. This task includes three trials of six geometric figures printed in a 2 x 3 array on separate pages. The respondent views the stimulus page for 10 seconds and is asked to draw as many of the figures as possible in their correct location on a page in the response booklet. A Delayed Recall Trial is administered after a 25-minute delay. Scoring is based on accuracy of the figure as well as its location on the page. A range of 0-12 per trial is possible(0-36 total). Higher scores are better. (NCT01232790)
Timeframe: Follow Up 2nd Leg of Crossover (5 Days)
| Intervention | units on a scale (Mean) |
|---|
| Group A: NAC 1st Trial, Placebo 2nd Trial | 18.82 |
| Group B: Placebo 1st Trial, NAC 2nd Trial | 17.44 |
BACS Composite RAW Score
"The Brief Assessment of Cognition in Schizophrenia (BACS) is an instrument that assesses the aspects of cognition found to be most impaired and most strongly correlated with outcome in patients with schizophrenia.~The BACS composite raw score the total of the raw scores for the 6 subtests of the BACS (Verbal memory, token motor, digit sequencing, verbal fluency, symbol coding and executive functioning). The range, so we could be from 0-435. A high score total score is more favorable and indicates a higher level of cognition.~The BACS requires less than 35 min to complete in patients with schizophrenia, yields a high completion rate in these patients, and has high reliability. The BACS was found to be as sensitive to cognitive impairment in patients with schizophrenia as a standard battery of tests that required over 2 h to administer. It is the raw sum of the test items and higher scores are favorable." (NCT01232790)
Timeframe: Follow Up 1st Leg of Crossover (5 Days)
| Intervention | units on a scale (Mean) |
|---|
| Group A: NAC 1st Trial, Placebo 2nd Trial | 231.58 |
| Group B: Placebo 1st Trial, NAC 2nd Trial | 237.00 |
Brief Visuospatial Memory Test (BVMT) RAW SCORE.
Brief Visuospatial Memory Test (BVMT) is a measure of visuospatial memory. This task includes three trials of six geometric figures printed in a 2 x 3 array on separate pages. The respondent views the stimulus page for 10 seconds and is asked to draw as many of the figures as possible in their correct location on a page in the response booklet. A Delayed Recall Trial is administered after a 25-minute delay. Scoring is based on accuracy of the figure as well as its location on the page. A range of 0-12 per trial is possible(0-36 total). Higher scores are better. (NCT01232790)
Timeframe: Follow Up (5 days)
| Intervention | units on a scale (Mean) |
|---|
| Intervention | 17.90 |
| Placebo | 17.68 |
Brief Visuospatial Memory Test (BVMT) RAW SCORE.
Brief Visuospatial Memory Test (BVMT) is a measure of visuospatial memory. This task includes three trials of six geometric figures printed in a 2 x 3 array on separate pages. The respondent views the stimulus page for 10 seconds and is asked to draw as many of the figures as possible in their correct location on a page in the response booklet. A Delayed Recall Trial is administered after a 25-minute delay. Scoring is based on accuracy of the figure as well as its location on the page. A range of 0-12 per trial is possible(0-36 total). Higher scores are better. (NCT01232790)
Timeframe: Change from Baseline at Follow Up (Baseline - Follow Up)
| Intervention | units on a scale (Mean) |
|---|
| Intervention | 2.57 |
| Placebo | 2.77 |
Brief Visuospatial Memory Test (BVMT) RAW SCORE.
Brief Visuospatial Memory Test (BVMT) is a measure of visuospatial memory. This task includes three trials of six geometric figures printed in a 2 x 3 array on separate pages. The respondent views the stimulus page for 10 seconds and is asked to draw as many of the figures as possible in their correct location on a page in the response booklet. A Delayed Recall Trial is administered after a 25-minute delay. Scoring is based on accuracy of the figure as well as its location on the page. A range of 0-12 per trial is possible(0-36 total). Higher scores are better. (NCT01232790)
Timeframe: Baseline
| Intervention | units on a scale (Mean) |
|---|
| Intervention | 20.35 |
| Placebo | 20.65 |
Brief Visuospatial Memory Test (BVMT) RAW SCORE.
Brief Visuospatial Memory Test (BVMT) is a measure of visuospatial memory. This task includes three trials of six geometric figures printed in a 2 x 3 array on separate pages. The respondent views the stimulus page for 10 seconds and is asked to draw as many of the figures as possible in their correct location on a page in the response booklet. A Delayed Recall Trial is administered after a 25-minute delay. Scoring is based on accuracy of the figure as well as its location on the page. A range of 0-12 per trial is possible(0-36 total). Higher scores are better. (NCT01232790)
Timeframe: Baseline 2nd Leg of Crossover
| Intervention | units on a scale (Mean) |
|---|
| Group A: NAC 1st Trial, Placebo 2nd Trial | 21.50 |
| Group B: Placebo 1st Trial, NAC 2nd Trial | 20.00 |
Brief Visuospatial Memory Test (BVMT) RAW SCORE.
Brief Visuospatial Memory Test (BVMT) is a measure of visuospatial memory. This task includes three trials of six geometric figures printed in a 2 x 3 array on separate pages. The respondent views the stimulus page for 10 seconds and is asked to draw as many of the figures as possible in their correct location on a page in the response booklet. A Delayed Recall Trial is administered after a 25-minute delay. Scoring is based on accuracy of the figure as well as its location on the page. A range of 0-12 per trial is possible(0-36 total). Higher scores are better. (NCT01232790)
Timeframe: Baseline 1st Leg of Crossover
| Intervention | units on a scale (Mean) |
|---|
| Group A: NAC 1st Trial, Placebo 2nd Trial | 20.67 |
| Group B: Placebo 1st Trial, NAC 2nd Trial | 19.73 |
BACS Composite RAW Score
"The Brief Assessment of Cognition in Schizophrenia (BACS) is an instrument that assesses the aspects of cognition found to be most impaired and most strongly correlated with outcome in patients with schizophrenia.~The BACS composite raw score the total of the raw scores for the 6 subtests of the BACS (Verbal memory, token motor, digit sequencing, verbal fluency, symbol coding and executive functioning). The range, so we could be from 0-435. A high score total score is more favorable and indicates a higher level of cognition.~The BACS requires less than 35 min to complete in patients with schizophrenia, yields a high completion rate in these patients, and has high reliability. The BACS was found to be as sensitive to cognitive impairment in patients with schizophrenia as a standard battery of tests that required over 2 h to administer. It is the raw sum of the test items and higher scores are favorable." (NCT01232790)
Timeframe: Baseline 1st Leg of Crossover
| Intervention | units on a scale (Mean) |
|---|
| Group A: NAC 1st Trial, Placebo 2nd Trial | 222.75 |
| Group B: Placebo 1st Trial, NAC 2nd Trial | 226.45 |
BACS Composite RAW Score
"The Brief Assessment of Cognition in Schizophrenia (BACS) is an instrument that assesses the aspects of cognition found to be most impaired and most strongly correlated with outcome in patients with schizophrenia.~The BACS composite raw score the total of the raw scores for the 6 subtests of the BACS (Verbal memory, token motor, digit sequencing, verbal fluency, symbol coding and executive functioning). The range, so we could be from 0-435. A high score total score is more favorable and indicates a higher level of cognition.~The BACS requires less than 35 min to complete in patients with schizophrenia, yields a high completion rate in these patients, and has high reliability. The BACS was found to be as sensitive to cognitive impairment in patients with schizophrenia as a standard battery of tests that required over 2 h to administer. It is the raw sum of the test items and higher scores are favorable." (NCT01232790)
Timeframe: Baseline 2nd Leg of Crossover
| Intervention | units on a scale (Mean) |
|---|
| Group A: NAC 1st Trial, Placebo 2nd Trial | 229.08 |
| Group B: Placebo 1st Trial, NAC 2nd Trial | 235.91 |
Intracellular Glutathione Level
Mean intracellular glutathione level every 2 hour (NCT01251315)
Timeframe: 6 hours
| Intervention | µmol/L (Mean) |
|---|
| Baseline | 2 hour | 4 hour | 6 hour |
|---|
| N Acetyl Cysteine-A | 118.5 | 121.8 | 149.8 | 103.5 |
,| N Acetyl Cysteine-B | 147.8 | 149.5 | 133.5 | 125.0 |
,| Placebo-A | 221.5 | 242.3 | 178.0 | 236.5 |
,| Placebo-B | 358.0 | 347.8 | 383.8 | 355.0 |
,| Proimmune 200-A | 508.5 | 342.8 | 440.8 | 317.8 |
,| Proimmune 200-B | 132.8 | 311.8 | 279.8 | 274.0 |
Augmentation Index
"Augmentation index (%) is defined as the percentage of the central pulse pressure which is attributed to the reflected pulse wave and, therefore, reflects the degree to which central arterial pressure is augmented by wave reflection if appropriate augmentation index has been shown to be a predictor of adverse cardiovascular events in a high risk patient populations,higher augmentation index is associated with target organ damage. Absolute change of augmentation index from baseline to 6 hours will be estimated for the analysis." (NCT01251315)
Timeframe: Baseline and 6 hours
| Intervention | percentage of the central pulse pressure (Mean) |
|---|
| Baseline | 6 hour |
|---|
| N Acetyl Cysteine-A | 19.8 | 11.3 |
,| N Acetyl Cysteine-B | 20.3 | 17.5 |
,| Placebo-A | 20 | 11.3 |
,| Placebo-B | 27 | 24.8 |
,| Proimmune 200-A | 28.5 | 19 |
,| Proimmune 200-B | 26.5 | 19.3 |
Change From Baseline in Hemoglobin-A1c
Hemoglobin A1C was assessed at the end of the run in period and after 3 months of administration of study interventions. Here is delta HgA1C is reported between the two periods (NCT01265563)
Timeframe: Baseline and 3 months
| Intervention | percentage (Mean) |
|---|
| NAC Placebo + Silibin Placebo | 0.35 |
| NAC Active + Silibin Placebo | -0.18 |
| NAC Placebo + Silibin Active | 0.72 |
| NAC Active + Silibin Active | 0.4 |
| NAC Active + High-dose Silibin Active | 0.2 |
Change From Baseline in Urinary Albumin Excretion
Urine albumin to creatinine ratio was assessed at the end of run in period and after 3 months administration of study intervention. (NCT01265563)
Timeframe: Baseline and 3 months
| Intervention | mg/g (Mean) |
|---|
| NAC Placebo + Silibin Placebo | 50.5 |
| NAC Active + Silibin Placebo | -28.13 |
| NAC Placebo + Silibin Active | -4.5 |
| NAC Active + Silibin Active | 96.6 |
| NAC Active + High-dose Silibin Active | 353.71 |
Number of Participants Who Experienced Adverse Events
"The number of patients experiencing one or more of the following adverse events:~Acute renal failure Anaphylaxis Acute respiratory distress syndrome Intracranial infection/abscess Arrhythmia, atrial Arrhythmia, ventricular Bradycardia Cardiac arrest Catheter positive culture Cerebrospinal fluid leak Decubitis Deep vein thrombosis Diabetes Insipidus Emesis Extraaxial hematoma Gastrointestinal bleed Gastritis Hematuria Hemorrhage, other Hemoperitonium Hemothorax Hepatitis Hydrocephalus Hypotension Hypoxemia Infection, other Intraparenchymal hemorrhage Intraventricular hemorrhage Meningitis/ventriculitis Multiorgan dysfunction syndrome Myocardial ischemia Pancreatitis Pericarditis Peritonitis Pneumothorax Pulmonary edema Pulmonary embolism Respiratory arrest Seizures Sepsis Syndrome of inappropriate antidiuretic hormone Transtentorial herniation Withdrawal of Life Support Other SAE causing re-hospitalization Other SAE" (NCT01322009)
Timeframe: 14 days after drug administration
| Intervention | participants (Number) |
|---|
| Drug | 0 |
| Placebo | 2 |
Antioxidant Reserve
Antioxidant reserves in CSF and serum will be calculated in both treatment arms and compared. (NCT01322009)
Timeframe: Within 5 days of injury
| Intervention | reactive oxygen species scavenged (Mean) |
|---|
| Drug | 751 |
| Placebo | 735 |
Symptoms of a Psychotic Disorder
Determine if 12 months of NAC add-on treatment is superior to placebo for symptom management of a psychotic disorder as assessed by the Positive and Negative Syndrome Scale (PANSS). The PANSS is a semi-structured interview, containing 30 items that assess positive, negative, and general psychopathology symptoms. Positive symptoms=7 items, negative symptoms=7 items, and general psych.=16 items. Scores for each item range from 1-absent to 7-extreme. To calculate total score, all items on the scale are summed to yield a score from 30-210,a lower score reflecting fewer symptoms. To calculate factor scores various items from positive, negative, and general psych. are summed together to yield Cognitive/Disorganized, Negative, and Positive factor scores. Cog/Disorg factor scores sum 7 items, ranging from 7-49. Neg factor scores sum 7 items, ranging from 7-49. Pos factor scores sum 8 items, ranging from 8-56. For all factor scores a lower score reflects less symptom severity. (NCT01339858)
Timeframe: 12 months
| Intervention | scores on a scale (Least Squares Mean) |
|---|
| PANSS Total Score at 52 Weeks | PANSS Cognitive/Disorganized Factor at 52 Weeks | PANSS Negative Symptom Factor at 52 Weeks | PANSS Positive Symptom Factor at 52 Weeks |
|---|
| N-Acetyl Cysteine | 46.79 | 11.09 | 10.35 | 14.77 |
,| Sugar Pill | 56.44 | 13.68 | 13.22 | 16.38 |
Mismatch Negativity Voltage Differences
Determine if 12 months of NAC add-on treatment is superior to placebo for attention measures as measured by the voltage of the Mismatch Negativity (MMN) of the event-related potential. The voltage of the peak MMN response was measured at the Fz electrode site. (NCT01339858)
Timeframe: 12 months
| Intervention | microvolts (Least Squares Mean) |
|---|
| N-Acetyl Cysteine | -2.51 |
| Sugar Pill | -3.44 |
Working Memory
determine if 12 months of NAC add-on treatment is superior to placebo as determined by brain activity during n-back working memory task during fMRI. (NCT01339858)
Timeframe: Baseline and 12 months
| Intervention | Bold signal change (Mean) |
|---|
| Baseline pre exposure to NAC | 6 months exposure to NAC | 12 months exposure to NAC |
|---|
| N-Acetyl Cysteine | 0.299 | 0.351 | 0.315 |
,| Sugar Pill | 0.356 | 0.398 | 0.406 |
Number of Participants With Glutamine/Glutamate Level Changes
Identify number of participants with 12 months of NAC treatment who had glutamine/glutamate level changes as measured by cortical magnetic resonance spectroscopy measures. (NCT01339858)
Timeframe: 12 months
| Intervention | Participants (Count of Participants) |
|---|
| NAC Treated Early Psychosis Patients | 18 |
| Placebo Group | 0 |
Attention Measures
determine if 12 months of NAC add-on treatment is superior to placebo for attention measures (e.g., mismatch negativity, P300) as measured by electrophysiology methods. Electrophysiology measures will be recorded from a 64 channel, silver/silver-chloride scalp electrode montage. (NCT01339858)
Timeframe: 12 months
| Intervention | Hz (Least Squares Mean) |
|---|
| EEG Alpha power | EEG Delta power | EEG Gamma power | EEG Theta power | Auditory Steady State Response 40 Hz |
|---|
| N-Acetyl Cysteine | 3.81 | 2.96 | 0.37 | 1.33 | 0.05 |
,| Sugar Pill | 4.18 | 3.46 | 0.47 | 1.33 | 0.06 |
Cognitive Functioning
determine if 12 months of NAC add-on treatment is superior to placebo for cognitive functioning as measured by the Brief Assessment of Cognition in Schizophrenia (BACS). The BACS is a battery specifically designed to measure treatment-related changes in cognition by utilizing 6 tasks, and has alternate forms, thus minimizing practice effects. Each task generates a raw score (with a higher score indicating better performance): verbal memory 0-75; digit sequencing 0-28; token motor task 0-100; semantic&letter fluency 0-148; symbol coding 0-110; and tower of London 0-22. The raw scores are used to generate a composite score that is calculated by summing t-scores derived by comparisons with a normative sample of 404 healthy controls. The six brief assessments' t-scores, are summed, and averaged to provide a composite t-score. The composite score min and max are between -43 and 100. A higher score indicating better cognitive performance. (NCT01339858)
Timeframe: Baseline and 12 months
| Intervention | scores on a scale (Least Squares Mean) |
|---|
| BACS Composite Score Baseline | BACS Composite Score at 52 Weeks |
|---|
| N-Acetyl Cysteine | 26.91 | 30.03 |
,| Sugar Pill | 27.70 | 29.37 |
Cortical Thickness
We anticipate that 12 months treatment with NAC as an add-on treatment will show significantly less cortical erosion as measured by cortical thickness than treatment with placebo (NCT01339858)
Timeframe: 12 months
| Intervention | mm (Least Squares Mean) |
|---|
| Left Total Cortical Thickness at 52 Weeks | Right Total Cortical Thickness at 52 weeks | Left Caudal Middle Frontal Thickness at 52 Weeks | Right Caudal Middle Frontal Thickness at 52 Weeks | Left Middle Temporal Thickness at 52 Weeks | Right Middle Temporal Thickness at 52 Weeks | Left Superior Parietal Thickness at 52 Weeks | Right Superior Parietal Thickness at 52 Weeks |
|---|
| N-Acetyl Cysteine | 2.53 | 2.51 | 2.59 | 2.49 | 2.84 | 2.91 | 2.16 | 2.17 |
,| Sugar Pill | 2.54 | 2.52 | 2.57 | 2.49 | 2.87 | 2.95 | 2.21 | 2.18 |
Symptoms of a Psychotic Disorder
determine if 12 months of NAC add-on treatment is superior to placebo for symptom management of a psychotic disorder as assessed by the Clinical Global Impressions Severity Scale (CGI-S). The CGI-S is used for repeated evaluations of global psychopathology and is a 7 point Likert scale rating severity on a scale of 1 (normal, not ill) to 7 (very severely ill). (NCT01339858)
Timeframe: 12 months
| Intervention | scores on a scale (Least Squares Mean) |
|---|
| N-Acetyl Cysteine | 2.78 |
| Sugar Pill | 3.00 |
Cortical Volume
We anticipate that 12 months treatment with NAC as an add-on treatment will show a difference in cortical volume than treatment with placebo (NCT01339858)
Timeframe: 12 months
| Intervention | mm^3 (Least Squares Mean) |
|---|
| Total Cortical Gray Matter Volume at 52 Weeks | Total Cortical White Matter Volume at 52 Weeks |
|---|
| N-Acetyl Cysteine | 233.0 | 423.8 |
,| Sugar Pill | 235.8 | 418.5 |
Functional Status
determine if 12 months of NAC add-on treatment is superior to placebo for functional measures as measured by the Personal and Social Performance Scale (PSP). The PSP scale is a 100-point, single item, clinician rated scale to assess 4 domains of functioning, including personal and social relationships, socially useful activities, self care and disturbing and aggressive behaviors. A score from 0-100 is generated, with a higher score representing better performance. (NCT01339858)
Timeframe: Baseline and 12 months
| Intervention | scores on a scale (Least Squares Mean) |
|---|
| PSP Adjusted Score at Baseline | PSP Adjusted Score at 52 Weeks |
|---|
| N-Acetyl Cysteine | 62.51 | 64.51 |
,| Sugar Pill | 64.46 | 65.44 |
Social and Occupational Functioning Assessment Scale (SOFAS)
"Measure of social and occupational functioning using the Social and Occupational Functioning Assessment Scale Measure Description: Rating of Overall Social and Occupational Functioning on a scale of 1 (worst) to 100 (best) in groups of 10:~100-91: Superior functioning 90-81: Good functioning 80-71: Slight impairment 70-61: Some difficulty 60-51: Moderate difficulty 50-41: Serious impairment 40-31: Major impairment 30-21: Inability to function in almost all areas 20-11: Unable to function independently 10-1: Unable to function without harming self or others" (NCT01354132)
Timeframe: at 6 months
| Intervention | units on a scale (Mean) |
|---|
| N-acetyl-cysteine | 54.6 |
| Placebo | 54.8 |
Myo-Inositol Brain Level for the NAC Group
Myo-Inositol is measured in the medial prefrontal cortex using Magnetic Resonance Spectroscopy (H-MRS)MRS and is a chemical that works to protect the brain from high levels of excitatory chemicals such as glutamate. (NCT01354132)
Timeframe: at 6 months
| Intervention | mM (Mean) |
|---|
| N-acetyl-cysteine | 6.27 |
Change in Cognition and Working Memory (MATRICS) Attention and Vigilance
The MATRICS is neurocognitive battery designed to assess cognition. Sustained attention and Vigilance is a composite score based on the Continuous Performance Test -Identical Pairs. The score is a standardized T-Score which indicates the number of standard deviations above or below the mean, a T-Score of 50, in 10 point increments. A T-Score of 60 indicates 1 standard deviation above the mean and a T-Score of 40 indicates 1 standard deviation below the mean. A score below 50 indicated cognitive processing below that of an age and gender matched healthy control population. A score above 50 indicates cognitive processing above that of an age and gender matched healthy control population. (NCT01354132)
Timeframe: at 6 months
| Intervention | T- Scores (Mean) |
|---|
| N-acetyl-cysteine | 40.92 |
| Placebo | 30.40 |
GPxbc Glutathione Peroxidase Activity in Blood Cells
GPxBC is a measurement of glutathiione peroxidase enzymatic activity in glutathione synthesis and the redox system in blood cells. Measured as umol/min/gHb from blood cells. (NCT01354132)
Timeframe: at 6 months
| Intervention | umol/min/gHb (Mean) |
|---|
| N-acetyl-cysteine | 21.24 |
| Placebo | 21.01 |
Glutathione Brain Level for Placebo Group
measured by H-MRS in the medial prefrontal cortex Brain markers, glutathione was measured using Magnetic Resonance Spectroscopy (H-MRS) in the medial prefrontal cortex. Glutathione is a tripeptide comprised of three amino acids (cysteine, glutamic acid, and glycine) and acts as an antioxidant, a free radical scavanger and a detoxifying agent. Glutathione is an important co-factor for the enzyme glutathione peroxidase used in the uptake of amino acids. (NCT01354132)
Timeframe: at 6 months
| Intervention | mM (Mean) |
|---|
| Placebo Group | 1.05 |
Glutathione Brain Level for NAC Group
measured by H-MRS in the medial prefrontal cortex Brain markers, glutathione was measured using Magnetic Resonance Spectroscopy (H-MRS) in the medial prefrontal cortex. Glutathione is a tripeptide comprised of three amino acids (cysteine, glutamic acid, and glycine) and acts as an antioxidant, a free radical scavanger and a detoxifying agent. Glutathione is an important co-factor for the enzyme glutathione peroxidase used in the uptake of amino acids. (NCT01354132)
Timeframe: at 6 months
| Intervention | mM (Mean) |
|---|
| N-acetyl-cysteine | 1.04 |
Glutamine Brain Level for Placebo Group
Glutamine is measured in the medial prefrontal cortex using Magnetic Resonance Spectroscopy (H-MRS) and is a chemical that works to protect the brain from high levels of excitatory chemicals such as glutamate. (NCT01354132)
Timeframe: at 6 months
| Intervention | mM (Mean) |
|---|
| Placebo Group | 2.90 |
Glutamine Brain Level for NAC Group
Glutamine is measured in the medial prefrontal cortex using Magnetic Resonance Spectroscopy (H-MRS) and is a chemical that works to protect the brain from high levels of excitatory chemicals such as glutamate. (NCT01354132)
Timeframe: at 6 months
| Intervention | mM (Mean) |
|---|
| N-acetyl-cysteine | 3.16 |
Glutamate Brain Level for NAC Group
Brain marker, glutamate, was measured using Magnetic Resonance Spectroscopy (H-MRS) in the medial prefrontal cortex. Glutamate is an excitatory neurotransmitter in the brain. (NCT01354132)
Timeframe: at 6 months
| Intervention | mM (Mean) |
|---|
| N-acetyl-cysteine | 10.25 |
Change in Cognition and Working Memory (MATRICS) Reasoning and Problem Solving
The MATRICS is neurocognitive battery designed to assess cognition. Problem Solving is a composite score based on the NAB Mazes. The score is a standardized T-Score which indicates the number of standard deviations above or below the mean, a T-Score of 50, in 10 point increments. A T-Score of 60 indicates 1 standard deviation above the mean and a T-Score of 40 indicates 1 standard deviation below the mean. A score below 50 indicated cognitive processing below that of an age and gender matched healthy control population. A score above 50 indicates cognitive processing above that of an age and gender matched healthy control population. (NCT01354132)
Timeframe: at 6 months
| Intervention | T- Scores (Mean) |
|---|
| N-acetyl-cysteine | 51.13 |
| Placebo | 44.38 |
Change in Cognition and Working Memory (MATRICS) Speed of Processing
The MATRICS is neurocognitive battery designed to assess cognition. Processing speed is a composite score including the following tests: Trail Making Test, BACS: Symbol Coding, Category Fluency: Animal Naming. The score is a standardized T-Score which indicates the number of standard deviations above or below the mean, a T-Score of 50, in 10 point increments. A T-Score of 60 indicates 1 standard deviation above the mean and a T-Score of 40 indicates 1 standard deviation below the mean. A score below 50 indicated cognitive processing below that of an age and gender matched healthy control population. A score above 50 indicates cognitive processing above that of an age and gender matched healthy control population. (NCT01354132)
Timeframe: at 6 months
| Intervention | T- Scores (Mean) |
|---|
| N-acetyl-cysteine | 41.47 |
| Placebo | 35.85 |
Change in Cognition and Working Memory (MATRICS) Verbal Learning
The MATRICS is neurocognitive battery designed to assess cognition. Verbal Learning is a composite score based on the Hopkins Verbal Learning Test-Revised: Immediate Recall. The score is a standardized T-Score which indicates the number of standard deviations above or below the mean, a T-Score of 50, in 10 point increments. A T-Score of 60 indicates 1 standard deviation above the mean and a T-Score of 40 indicates 1 standard deviation below the mean. A score below 50 indicated cognitive processing below that of an age and gender matched healthy control population. A score above 50 indicates cognitive processing above that of an age and gender matched healthy control population. (NCT01354132)
Timeframe: at 6 months
| Intervention | T- Scores (Mean) |
|---|
| N-acetyl-cysteine | 42.18 |
| Placebo | 44.62 |
Change in Cognition and Working Memory (MATRICS) Visual Learning
The MATRICS is neurocognitive battery designed to assess cognition. Visual Learning is a composite score based on the Brief Visuospatial Memory test - Revised: Immediate Recall. The score is a standardized T-Score which indicates the number of standard deviations above or below the mean, a T-Score of 50, in 10 point increments. A T-Score of 60 indicates 1 standard deviation above the mean and a T-Score of 40 indicates 1 standard deviation below the mean. A score below 50 indicated cognitive processing below that of an age and gender matched healthy control population. A score above 50 indicates cognitive processing above that of an age and gender matched healthy control population. (NCT01354132)
Timeframe: at 6 months
| Intervention | T- Scores (Mean) |
|---|
| N-acetyl-cysteine | 46.00 |
| Placebo | 47.75 |
Change in Cognition and Working Memory (MATRICS) Working Memory
The MATRICS is neurocognitive battery designed to assess cognition. Working Memory score is a composite score based on the following sub-test WMS-III Spatial Span and Letter-Number Span. The score is a standardized T-Score which indicates the number of standard deviations above or below the mean, a T-Score of 50, in 10 point increments. A T-Score of 60 indicates 1 standard deviation above the mean and a T-Score of 40 indicates 1 standard deviation below the mean. A score below 50 indicated cognitive processing below that of an age and gender matched healthy control population. A score above 50 indicates cognitive processing above that of an age and gender matched healthy control population. (NCT01354132)
Timeframe: at 6 months
| Intervention | T- Scores (Mean) |
|---|
| N-acetyl-cysteine | 47.47 |
| Placebo | 38.08 |
Change in Negative Symptoms of Schizophrenia as Measured on the PANSS
"Positive and Negative Symptom Scale was used to assess psychopathology. The sum of items N1 - N7 including N1) blunted affect, N2) emotional withdrawal, N3) poor rapport, N4) passive apathetic social withdrawal, N5) difficulty in abstract thinking, N6) lack of spontaneity and flow of conversation, and N7) sterotyped thinking were used to analyze negative symptoms of schizophrenia and were assessed for the previous week:~RATING SCALE~1: Absent 2: Minimal 3: Mild 4: Moderate 5: Moderate Severe 6: Severe 7: Extreme The higher the score the worse the symptoms. The lowest possible score is 7 and the highest possible score is 49 ." (NCT01354132)
Timeframe: at 6 months
| Intervention | units on a scale (Mean) |
|---|
| N-acetyl-cysteine | 16.9 |
| Placebo | 17.2 |
Change in Positive Symptoms (PANSS)
"Positive and Negative Symptom Scale was used to assess psychopathology. The Positive symptom subscale of schizophrenia includes the sum of items P1 -P7 including P1) Delusions, P2) conceptual Disorganization, P3) Hallunicatory Behavior, P4) Excitement, P5) Grandiosity, P6) Suspiciousness and Persecution, and P7) Hostility and were assessed for the previous week:~RATING SCALE~1: Absent 2: Minimal 3: Mild 4: Moderate 5: Moderate Severe 6: Severe 7: Extreme The higher the score the worse the symptoms. The lowest possible score is 7 and the highest possible score is 49 ." (NCT01354132)
Timeframe: at 6 months
| Intervention | units on a scale (Mean) |
|---|
| N-acetyl-cysteine | 13.7 |
| Placebo | 12.5 |
Change in Blood Level of Glutathione
Glutathione is a tripeptide comprised of three amino acids (cysteine, glutamic acid, and glycine) and acts as an antioxidant, a free radical scavanger and a detoxifying agent. Glutathione is an important co-factor for the enzyme glutathione peroxidase used in the uptake of amino acids. The level of glutathione is measured in blood cells. (NCT01354132)
Timeframe: at 6 months
| Intervention | mM (Mean) |
|---|
| N-acetyl-cysteine | 0.92 |
| Placebo | 0.82 |
Global Assessment of Functioning (GAF)
"Measure Description: Clinical Measure of Global level of Symptoms (Sx) and Functioning from 1 (Worst) to 100 (Best) in groups of 10:~100 - 91: Superior functioning 90 - 81: Absent or minimal Sx 80 - 71: If symptoms are present and expected 70 - 61:Some mild Sx 60 - 51: Moderate Sx 50 - 41: Serious Sx 40 - 31: Some impairment in reality testing or communication 30 - 21: Behavior is considerably influenced by delusions or hallucinations 20 - 11: Some danger of hurting self or others 10 - 1: Persistent danger of severely hurting self or others" (NCT01354132)
Timeframe: at 6 months
| Intervention | units on a scale (Mean) |
|---|
| N-acetyl-cysteine | 52.2 |
| Placebo | 53.8 |
Glutamate Brain Level for Placebo Group
Glutamine is measured in the medial prefrontal cortex using Magnetic Resonance Spectroscopy (H-MRS) and is a chemical that works to protect the brain from high levels of excitatory chemicals such as glutamate. (NCT01354132)
Timeframe: at 6 months
| Intervention | mM (Mean) |
|---|
| Placebo Group | 10.65 |
Blood Plasma Level of Cysteine
Cysteine is an amino acid, a building block for proteins and is used throughout the body and was measured in blood plasma. (NCT01354132)
Timeframe: at 6 months
| Intervention | uM (Mean) |
|---|
| N-acetyl-cysteine | 229.6 |
| Placebo | 246.5 |
Myo-Inositol Brain Level for Placebo Group
Myo-Inositol is measured in the medial prefrontal cortex using Magnetic Resonance Spectroscopy (H-MRS)MRS and is a chemical that works to protect the brain from high levels of excitatory chemicals such as glutamate. (NCT01354132)
Timeframe: at 6 months
| Intervention | mM (Mean) |
|---|
| Placebo Group | 6.26 |
Perceptual Fatigue of Whole Body as Measured by Visual Analog Scale After Handgrip Fatigue Test After Study Intervention
"The Visual Analog Scale for Fatigue is an 11cm long line. The subject is asked to mark their level of fatigue (0cm being no fatigue and 11cm being extreme fatigue). This test was performed before and after the handgrip fatigue test, where the non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes.~Handgrip testing was performed at baseline (before any intervention) and post dose three of the intervention, average of 17 hours post dose one intervention." (NCT01384591)
Timeframe: Post dose three of the intervention, average of 17 hours post dose one intervention - Directly after handgrip fatigue test
| Intervention | units on a scale (Mean) |
|---|
| Placebo Losartan and Placebo N-acetylcysteine | 1.25 |
| N-acetylcysteine and Placebo Losartan | 5.3 |
| Losartan and Placebo N-acetylcysteine | 0.95 |
Perceptual Fatigue of Non-dominant Arm as Measured by Visual Analog Scale Before Handgrip Fatigue Test at Baseline.
"The Visual Analog Scale for Fatigue is an 11cm long line. The subject is asked to mark their level of fatigue (0cm being no fatigue and 11cm being extreme fatigue). This test was performed before and after the handgrip fatigue test, where the non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes.~Handgrip testing was performed at baseline (before any intervention) and post dose three of the intervention, average of 17 hours post dose one intervention." (NCT01384591)
Timeframe: baseline - before handgrip fatigue test
| Intervention | units on a scale (Mean) |
|---|
| Placebo Losartan and Placebo N-acetylcysteine | 0.3 |
| N-acetylcysteine and Placebo Losartan | 3.3 |
| Losartan and Placebo N-acetylcysteine | 0.2 |
Perceptual Fatigue of Non-dominant Arm as Measured by Visual Analog Scale Before Handgrip Fatigue Test After Study Intervention
"The Visual Analog Scale for Fatigue is an 11cm long line. The subject is asked to mark their level of fatigue (0cm being no fatigue and 11cm being extreme fatigue). This test was performed before and after the handgrip fatigue test, where the non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes.~Handgrip testing was performed at baseline (before any intervention) and post dose three of the intervention, average of 17 hours post dose one intervention." (NCT01384591)
Timeframe: Post dose three of the intervention, average of 17 hours post dose one intervention - Before handgrip fatigue test
| Intervention | units on a scale (Mean) |
|---|
| Placebo Losartan and Placebo N-acetylcysteine | 1.45 |
| N-acetylcysteine and Placebo Losartan | 1 |
| Losartan and Placebo N-acetylcysteine | 0.65 |
Perceptual Fatigue of Non-dominant Arm as Measured by Visual Analog Scale After Handgrip Fatigue Test at Baseline.
"The Visual Analog Scale for Fatigue is an 11cm long line. The subject is asked to mark their level of fatigue (0cm being no fatigue and 11cm being extreme fatigue). This test was performed before and after the handgrip fatigue test, where the non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes.~Handgrip testing was performed at baseline (before any intervention) and post dose three of the intervention, average of 17 hours post dose one intervention." (NCT01384591)
Timeframe: baseline - directly after handgrip fatigue test
| Intervention | units on a scale (Mean) |
|---|
| Placebo Losartan and Placebo N-acetylcysteine | 2.7 |
| N-acetylcysteine and Placebo Losartan | 7.5 |
| Losartan and Placebo N-acetylcysteine | 0.6 |
Leg Blood Flow as Measured by Doppler Ultrasound
Femoral Doppler Blood Flow was evaluated via Doppler ultrasound. For the two-dimensional (2-D) and Doppler ultrasound measurements, an ultrasound system (HDI-5000; Philips Medical Systems, Bothell, WA) with a linear array transducer (L7-4) was used with a transmit frequency of 12MHz. 2-D imaging of the common femoral artery will be performed in the long axis. Images will be triggered to the R wave of the cardiac cycle, and the femoral artery diameter will be measured using online video calipers. A pulsed-wave Doppler sample blood volume will be placed at the same location in the center of the artery, and the mean blood velocity will be measured using online angle correction and analysis software. Femoral artery mean blood flow will be calculated from 2-D and Doppler ultrasound data using the equation: Q = vπ ∙ (d/2)2, where Q is femoral blood flow, v is mean femoral artery blood flow velocity, and d is femoral artery diameter. (NCT01384591)
Timeframe: Post dose three of the intervention and a meal, average of 17 hours post dose one of the intervention
| Intervention | ml/minute (Mean) |
|---|
| Placebo Losartan and Placebo N-acetylcysteine | 158.71 |
| N-acetylcysteine and Placebo Losartan | 109.94 |
| Losartan and Placebo N-acetylcysteine | 153.38 |
Leg Blood Flow as Measured by Doppler Ultrasound
Femoral Doppler Blood Flow was evaluated via Doppler ultrasound. For the two-dimensional (2-D) and Doppler ultrasound measurements, an ultrasound system (HDI-5000; Philips Medical Systems, Bothell, WA) with a linear array transducer (L7-4) was used with a transmit frequency of 12MHz. 2-D imaging of the common femoral artery will be performed in the long axis. Images will be triggered to the R wave of the cardiac cycle, and the femoral artery diameter will be measured using online video calipers. A pulsed-wave Doppler sample blood volume will be placed at the same location in the center of the artery, and the mean blood velocity will be measured using online angle correction and analysis software. Femoral artery mean blood flow will be calculated from 2-D and Doppler ultrasound data using the equation: Q = vπ ∙ (d/2)2, where Q is femoral blood flow, v is mean femoral artery blood flow velocity, and d is femoral artery diameter. (NCT01384591)
Timeframe: Baseline
| Intervention | ml/minute (Mean) |
|---|
| Placebo Losartan and Placebo N-acetylcysteine | 174.99 |
| N-acetylcysteine and Placebo Losartan | 102.08 |
| Losartan and Placebo N-acetylcysteine | 428.45 |
Leg Blood Flow as Measured by Doppler Ultrasound
Femoral Doppler Blood Flow was evaluated via Doppler ultrasound. For the two-dimensional (2-D) and Doppler ultrasound measurements, an ultrasound system (HDI-5000; Philips Medical Systems, Bothell, WA) with a linear array transducer (L7-4) was used with a transmit frequency of 12MHz. 2-D imaging of the common femoral artery will be performed in the long axis. Images will be triggered to the R wave of the cardiac cycle, and the femoral artery diameter will be measured using online video calipers. A pulsed-wave Doppler sample blood volume will be placed at the same location in the center of the artery, and the mean blood velocity will be measured using online angle correction and analysis software. Femoral artery mean blood flow will be calculated from 2-D and Doppler ultrasound data using the equation: Q = vπ ∙ (d/2)2, where Q is femoral blood flow, v is mean femoral artery blood flow velocity, and d is femoral artery diameter. (NCT01384591)
Timeframe: 2 hours post dose two of the intervention, average of 14 hours post dose one of the intervention
| Intervention | ml/minute (Mean) |
|---|
| Placebo Losartan and Placebo N-acetylcysteine | 214.56 |
| N-acetylcysteine and Placebo Losartan | 70.37 |
| Losartan and Placebo N-acetylcysteine | 114.34 |
Leg Blood Flow as Measured by Doppler Ultrasound
Femoral Doppler Blood Flow was evaluated via Doppler ultrasound. For the two-dimensional (2-D) and Doppler ultrasound measurements, an ultrasound system (HDI-5000; Philips Medical Systems, Bothell, WA) with a linear array transducer (L7-4) was used with a transmit frequency of 12MHz. 2-D imaging of the common femoral artery will be performed in the long axis. Images will be triggered to the R wave of the cardiac cycle, and the femoral artery diameter will be measured using online video calipers. A pulsed-wave Doppler sample blood volume will be placed at the same location in the center of the artery, and the mean blood velocity will be measured using online angle correction and analysis software. Femoral artery mean blood flow will be calculated from 2-D and Doppler ultrasound data using the equation: Q = vπ ∙ (d/2)2, where Q is femoral blood flow, v is mean femoral artery blood flow velocity, and d is femoral artery diameter. (NCT01384591)
Timeframe: 2 hours post dose three of the intervention and a meal, average of 19 hours post dose one of the intervention
| Intervention | ml/minute (Mean) |
|---|
| Placebo Losartan and Placebo N-acetylcysteine | 70.60 |
| N-acetylcysteine and Placebo Losartan | 128.78 |
| Losartan and Placebo N-acetylcysteine | 57.79 |
Leg Blood Flow as Measured by Doppler Ultrasound
Femoral Doppler Blood Flow was evaluated via Doppler ultrasound. For the two-dimensional (2-D) and Doppler ultrasound measurements, an ultrasound system (HDI-5000; Philips Medical Systems, Bothell, WA) with a linear array transducer (L7-4) was used with a transmit frequency of 12MHz. 2-D imaging of the common femoral artery will be performed in the long axis. Images will be triggered to the R wave of the cardiac cycle, and the femoral artery diameter will be measured using online video calipers. A pulsed-wave Doppler sample blood volume will be placed at the same location in the center of the artery, and the mean blood velocity will be measured using online angle correction and analysis software. Femoral artery mean blood flow will be calculated from 2-D and Doppler ultrasound data using the equation: Q = vπ ∙ (d/2)2, where Q is femoral blood flow, v is mean femoral artery blood flow velocity, and d is femoral artery diameter. (NCT01384591)
Timeframe: 12 hours post dose one of the intervention
| Intervention | ml/minute (Mean) |
|---|
| Placebo Losartan and Placebo N-acetylcysteine | 181.88 |
| N-acetylcysteine and Placebo Losartan | 69.83 |
| Losartan and Placebo N-acetylcysteine | 91.68 |
Leg Blood Flow as Measured by Doppler Ultrasound
Femoral Doppler Blood Flow was evaluated via Doppler ultrasound. For the two-dimensional (2-D) and Doppler ultrasound measurements, an ultrasound system (HDI-5000; Philips Medical Systems, Bothell, WA) with a linear array transducer (L7-4) was used with a transmit frequency of 12MHz. 2-D imaging of the common femoral artery will be performed in the long axis. Images will be triggered to the R wave of the cardiac cycle, and the femoral artery diameter will be measured using online video calipers. A pulsed-wave Doppler sample blood volume will be placed at the same location in the center of the artery, and the mean blood velocity will be measured using online angle correction and analysis software. Femoral artery mean blood flow will be calculated from 2-D and Doppler ultrasound data using the equation: Q = vπ ∙ (d/2)2, where Q is femoral blood flow, v is mean femoral artery blood flow velocity, and d is femoral artery diameter. (NCT01384591)
Timeframe: 1 hour post dose two of the intervention, average of 13 hours post dose 1 of the intervention
| Intervention | ml/minute (Mean) |
|---|
| Placebo Losartan and Placebo N-acetylcysteine | 105.80 |
| N-acetylcysteine and Placebo Losartan | 90.06 |
| Losartan and Placebo N-acetylcysteine | 95.60 |
Leg Blood Flow as Measured by Doppler Ultrasound
Femoral Doppler Blood Flow was evaluated via Doppler ultrasound. For the two-dimensional (2-D) and Doppler ultrasound measurements, an ultrasound system (HDI-5000; Philips Medical Systems, Bothell, WA) with a linear array transducer (L7-4) was used with a transmit frequency of 12MHz. 2-D imaging of the common femoral artery will be performed in the long axis. Images will be triggered to the R wave of the cardiac cycle, and the femoral artery diameter will be measured using online video calipers. A pulsed-wave Doppler sample blood volume will be placed at the same location in the center of the artery, and the mean blood velocity will be measured using online angle correction and analysis software. Femoral artery mean blood flow will be calculated from 2-D and Doppler ultrasound data using the equation: Q = vπ ∙ (d/2)2, where Q is femoral blood flow, v is mean femoral artery blood flow velocity, and d is femoral artery diameter. (NCT01384591)
Timeframe: 1 hour post dose three of the intervention and a meal, average of 18 hours post dose one of the intervention
| Intervention | ml/minute (Mean) |
|---|
| Placebo Losartan and Placebo N-acetylcysteine | 84.41 |
| N-acetylcysteine and Placebo Losartan | 104.40 |
| Losartan and Placebo N-acetylcysteine | 152.10 |
Handgrip Strength of Non-dominant Hand as Measured by Handgrip Dynamometry at 50% Perceived Effort at Baseline
Handgrip Strength of non-dominant hand is measured by handgrip dynamometry at 50% perceived effort with subjects performing one set of three contractions. (NCT01384591)
Timeframe: baseline
| Intervention | kilograms (Mean) |
|---|
| Placebo Losartan and Placebo N-acetylcysteine | 24.2 |
| N-acetylcysteine and Placebo Losartan | 19.3 |
| Losartan and Placebo N-acetylcysteine | 17.0 |
Handgrip Strength of Non-dominant Hand as Measured by Handgrip Dynamometry at 50% Perceived Effort After All Doses of Study Intervention
Handgrip Strength of non-dominant hand is measured by handgrip dynamometry at 50% perceived effort with subjects performing one set of three contractions. (NCT01384591)
Timeframe: Post dose three of the intervention, average of 17 hours post dose one intervention
| Intervention | kilograms (Mean) |
|---|
| Placebo Losartan and Placebo N-acetylcysteine | 17.8 |
| N-acetylcysteine and Placebo Losartan | 14.8 |
| Losartan and Placebo N-acetylcysteine | 13.7 |
Handgrip Strength of Non-dominant Hand as Measured by Handgrip Dynamometry at 100% Perceived Effort After All Doses of Study Intervention
Handgrip Strength of non-dominant hand is measured by handgrip dynamometry at 100% perceived effort with subjects performing one set of three contractions. (NCT01384591)
Timeframe: Post dose three of the intervention, average of 17 hours post dose one intervention
| Intervention | kilograms (Mean) |
|---|
| Placebo Losartan and Placebo N-acetylcysteine | 42.3 |
| N-acetylcysteine and Placebo Losartan | 28.6 |
| Losartan and Placebo N-acetylcysteine | 30.2 |
Handgrip Strength of Non-dominant Hand as Measured by Handgrip Dynamometry at 100% Effort at Baseline
Handgrip Strength of non-dominant hand is measured by handgrip dynamometry at 100% effort with subjects performing one set of three contractions. (NCT01384591)
Timeframe: baseline
| Intervention | kilograms (Mean) |
|---|
| Placebo Losartan and Placebo N-acetylcysteine | 47.1 |
| N-acetylcysteine and Placebo Losartan | 31.1 |
| Losartan and Placebo N-acetylcysteine | 26.5 |
Handgrip Strength of Dominant Hand as Measured by Handgrip Dynamometry at 50% Perceived Effort at Baseline
Handgrip Strength of dominant hand is measured by handgrip dynamometry at 50% perceived effort with subjects performing one set of three contractions. (NCT01384591)
Timeframe: baseline
| Intervention | kilograms (Mean) |
|---|
| Placebo Losartan and Placebo N-acetylcysteine | 21.5 |
| N-acetylcysteine and Placebo Losartan | 23.2 |
| Losartan and Placebo N-acetylcysteine | 20.5 |
Handgrip Strength of Dominant Hand as Measured by Handgrip Dynamometry at 50% Perceived Effort After All Doses of Study Intervention
Handgrip Strength of dominant hand is measured by handgrip dynamometry at 50% perceived effort with subjects performing one set of three contractions. (NCT01384591)
Timeframe: Post dose three of the intervention, average of 17 hours post dose one intervention
| Intervention | kilograms (Mean) |
|---|
| Placebo Losartan and Placebo N-acetylcysteine | 21.2 |
| N-acetylcysteine and Placebo Losartan | 15.8 |
| Losartan and Placebo N-acetylcysteine | 16.2 |
Handgrip Strength of Dominant Hand as Measured by Handgrip Dynamometry at 100% Perceived Effort After All Doses of Study Intervention
Handgrip Strength of dominant hand is measured by handgrip dynamometry at 100% perceived effort with subjects performing one set of three contractions. (NCT01384591)
Timeframe: Post dose three of the intervention, average of 17 hours post dose one intervention
| Intervention | kilograms (Mean) |
|---|
| Placebo Losartan and Placebo N-acetylcysteine | 44.1 |
| N-acetylcysteine and Placebo Losartan | 31.3 |
| Losartan and Placebo N-acetylcysteine | 24.2 |
Handgrip Strength of Dominant Hand as Measured by Handgrip Dynamometry at 100% Effort at Baseline
Handgrip Strength of dominant hand is measured by handgrip dynamometry at 100% effort with subjects performing one set of three contractions. (NCT01384591)
Timeframe: baseline
| Intervention | kilograms (Mean) |
|---|
| Placebo Losartan and Placebo N-acetylcysteine | 45.2 |
| N-acetylcysteine and Placebo Losartan | 33.2 |
| Losartan and Placebo N-acetylcysteine | 28.8 |
Handgrip Fatigue of Non-dominant Hand as Measured by Handgrip Dynamometry at Baseline
Handgrip fatigue of non-dominant hand as measured by handgrip dynamometry fatigue test. The non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes. Data is reported as % of Maximal Voluntary Contraction (MVC) after fatigue test. (NCT01384591)
Timeframe: baseline
| Intervention | % of Maximal Voluntary Contraction (Mean) |
|---|
| Placebo Losartan and Placebo N-acetylcysteine | 64.55 |
| N-acetylcysteine and Placebo Losartan | 83.62 |
| Losartan and Placebo N-acetylcysteine | 90.29 |
Handgrip Fatigue of Non-dominant Hand as Measured by Handgrip Dynamometry After All Doses of Study Intervention
Handgrip fatigue of non-dominant hand as measured by handgrip dynamometry fatigue test. The non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes. Data reported as % of Maximal Voluntary Contraction (MVC) after fatigue test. (NCT01384591)
Timeframe: Post dose three of the intervention, average of 17 hours post dose one intervention
| Intervention | % of Maximal Voluntary Contraction (Mean) |
|---|
| Placebo Losartan and Placebo N-acetylcysteine | 88.61 |
| N-acetylcysteine and Placebo Losartan | 93.25 |
| Losartan and Placebo N-acetylcysteine | 95.60 |
Handgrip Fatigue of Dominant Hand as Measured by Handgrip Dynamometry at Baseline
Handgrip fatigue of dominant hand as measured by handgrip dynamometry fatigue test. The non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes. Data is reported as % of Maximal Voluntary Contraction after fatigue test. (NCT01384591)
Timeframe: baseline
| Intervention | % of Maximal Voluntary Contraction (Mean) |
|---|
| Placebo Losartan and Placebo N-acetylcysteine | 129.6 |
| N-acetylcysteine and Placebo Losartan | 94.2 |
| Losartan and Placebo N-acetylcysteine | 103.4 |
Handgrip Fatigue of Dominant Hand as Measured by Handgrip Dynamometry After All Doses of Study Intervention
Handgrip fatigue of dominant hand as measured by handgrip dynamometry fatigue test. The non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes. Data reported as % of Maximal Voluntary Contraction (MVC) after fatigue test. (NCT01384591)
Timeframe: Post dose three of the intervention, average of 17 hours post dose one intervention
| Intervention | % of Maximal Voluntary Contraction (Mean) |
|---|
| Placebo Losartan and Placebo N-acetylcysteine | 101.0 |
| N-acetylcysteine and Placebo Losartan | 95.97 |
| Losartan and Placebo N-acetylcysteine | 111 |
Global Fatigue Score as Measured by Brief Fatigue Inventory at Baseline
"The Brief Fatigue Inventory is a 9 item questionnaire that assesses perceptual fatigue as well as fatigue interferences (e.g. interference with enjoyment of life), with 0 being no fatigue and 10 being as bad as you can imagine. The Global Fatigue score is calculated by averaging the answers of all the questions. Score ranges (0 to 10) with higher score indicating a worse outcome." (NCT01384591)
Timeframe: Baseline
| Intervention | units on a scale (Mean) |
|---|
| Placebo Losartan and Placebo N-acetylcysteine | 0.55 |
| N-acetylcysteine and Placebo Losartan | 0.38 |
| Losartan and Placebo N-acetylcysteine | 1.11 |
Global Fatigue Score as Measured by Brief Fatigue Inventory After Study Invention
"The Brief Fatigue Inventory is a 9 item questionnaire that assesses perceptual fatigue as well as fatigue interferences (e.g. interference with enjoyment of life), with 0 being no fatigue and 10 being as bad as you can imagine. The Global Fatigue score is calculated by averaging the answers of all the questions. Score range 0 to 10, with a higher score indicating a worse outcome." (NCT01384591)
Timeframe: Post dose three of the intervention, average of 17 hours post dose one intervention
| Intervention | units on a scale (Mean) |
|---|
| Placebo Losartan and Placebo N-acetylcysteine | 0.5 |
| N-acetylcysteine and Placebo Losartan | 0.22 |
| Losartan and Placebo N-acetylcysteine | 1.19 |
Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Total Score at Baseline
"Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue.~There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score.~The range of the total score is -24 to 96, with the higher the number meaning more fatigue." (NCT01384591)
Timeframe: Baseline
| Intervention | units on a scale (Mean) |
|---|
| Placebo Losartan and Placebo N-acetylcysteine | -16.5 |
| N-acetylcysteine and Placebo Losartan | -12.5 |
| Losartan and Placebo N-acetylcysteine | -1.5 |
Perceptual Fatigue of Non-dominant Arm as Measured by Visual Analog Scale After Handgrip Fatigue Test After Study Intervention
"The Visual Analog Scale for Fatigue is an 11cm long line. The subject is asked to mark their level of fatigue (0cm being no fatigue and 11cm being extreme fatigue). This test was performed before and after the handgrip fatigue test, where the non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes.~Handgrip testing was performed at baseline (before any intervention) and post dose three of the intervention, average of 17 hours post dose one intervention." (NCT01384591)
Timeframe: Post dose three of the intervention, average of 17 hours post dose one intervention - Directly after handgrip fatigue test
| Intervention | units on a scale (Mean) |
|---|
| Placebo Losartan and Placebo N-acetylcysteine | 3.4 |
| N-acetylcysteine and Placebo Losartan | 11 |
| Losartan and Placebo N-acetylcysteine | 0.75 |
Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Total Score After All Doses of Study Intervention
"Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue.~There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score.~The range of the total score is -24 to 96, with the higher the number meaning more fatigue." (NCT01384591)
Timeframe: Post dose three of the intervention, average of 17 hours post dose one intervention
| Intervention | units on a scale (Mean) |
|---|
| Placebo Losartan and Placebo N-acetylcysteine | -20 |
| N-acetylcysteine and Placebo Losartan | -12 |
| Losartan and Placebo N-acetylcysteine | 13.5 |
Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Vigor Fatigue at Baseline
"Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue.~There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score.~The range of the vigor scale is 0 to 24, with the higher number meaning more vigor.~The range of the total score is -24 to 96, with the higher the number meaning more fatigue." (NCT01384591)
Timeframe: Baseline
| Intervention | units on a scale (Mean) |
|---|
| Placebo Losartan and Placebo N-acetylcysteine | 18 |
| N-acetylcysteine and Placebo Losartan | 15 |
| Losartan and Placebo N-acetylcysteine | 16.5 |
Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Vigor Fatigue After All Doses of Study Intervention
"Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue.~There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score.~The range of the vigor scale is 0 to 24, with the higher number meaning more vigor.~The range of the total score is -24 to 96, with the higher the number meaning more fatigue." (NCT01384591)
Timeframe: Post dose three of the intervention, average of 17 hours post dose one intervention
| Intervention | units on a scale (Mean) |
|---|
| Placebo Losartan and Placebo N-acetylcysteine | 20.5 |
| N-acetylcysteine and Placebo Losartan | 15.5 |
| Losartan and Placebo N-acetylcysteine | 14 |
Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Physical Fatigue at Baseline
"Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue.~There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score.~The range of the physical fatigue scale is 24 to 0, with the higher number meaning more fatigue.~The range of the total score is -24 to 96, with the higher the number meaning more fatigue." (NCT01384591)
Timeframe: Baseline
| Intervention | units on a scale (Mean) |
|---|
| Placebo Losartan and Placebo N-acetylcysteine | 0.5 |
| N-acetylcysteine and Placebo Losartan | 0.5 |
| Losartan and Placebo N-acetylcysteine | 3 |
Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Physical Fatigue After All Doses of Study Intervention
"Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue.~There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score.~The range of the physical fatigue scale is 24 to 0, with the higher number meaning more fatigue.~The range of the total score is -24 to 96, with the higher the number meaning more fatigue." (NCT01384591)
Timeframe: Post dose three of the intervention, average of 17 hours post dose one intervention
| Intervention | units on a scale (Mean) |
|---|
| Placebo Losartan and Placebo N-acetylcysteine | 0 |
| N-acetylcysteine and Placebo Losartan | 0.5 |
| Losartan and Placebo N-acetylcysteine | 7 |
Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Mental Fatigue at Baseline
"Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue.~There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score.~The range of the mental fatigue scale is 24 to 0, with the higher number meaning more fatigue.~The range of the total score is -24 to 96, with the higher the number meaning more fatigue." (NCT01384591)
Timeframe: Baseline
| Intervention | units on a scale (Mean) |
|---|
| Placebo Losartan and Placebo N-acetylcysteine | 0.5 |
| N-acetylcysteine and Placebo Losartan | 0.5 |
| Losartan and Placebo N-acetylcysteine | 4.5 |
Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Mental Fatigue After All Doses of Study Intervention
"Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue.~There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score.~The range of the mental fatigue scale is 24 to 0, with the higher number meaning more fatigue~The range of the total score is -24 to 96, with the higher the number meaning more fatigue." (NCT01384591)
Timeframe: Post dose three of the intervention, average of 17 hours post dose one intervention
| Intervention | units on a scale (Mean) |
|---|
| Placebo Losartan and Placebo N-acetylcysteine | 0 |
| N-acetylcysteine and Placebo Losartan | 1 |
| Losartan and Placebo N-acetylcysteine | 6.5 |
Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale General Fatigue at Baseline
"Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue.~There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score.~The range of the general fatigue scale is 24 to 0, with the higher number meaning more fatigue.~The range of the total score is -24 to 96, with the higher the number meaning more fatigue." (NCT01384591)
Timeframe: Baseline
| Intervention | units on a scale (Mean) |
|---|
| Placebo Losartan and Placebo N-acetylcysteine | 0 |
| N-acetylcysteine and Placebo Losartan | 1.5 |
| Losartan and Placebo N-acetylcysteine | 3.5 |
Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale General Fatigue After All Doses of Study Intervention
"Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue.~There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score.~The range of the general fatigue scale is 24 to 0, with the higher number meaning more fatigue.~The range of the total score is -24 to 96, with the higher the number meaning more fatigue." (NCT01384591)
Timeframe: Post dose three of the intervention, average of 17 hours post dose one intervention
| Intervention | units on a scale (Mean) |
|---|
| Placebo Losartan and Placebo N-acetylcysteine | 0 |
| N-acetylcysteine and Placebo Losartan | 2 |
| Losartan and Placebo N-acetylcysteine | 6.5 |
Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Emotional Fatigue at Baseline
"Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue.~There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score.~The range of the emotional fatigue scale is 24 to 0, with the higher number meaning more fatigue.~The range of the total score is -24 to 96, with the higher the number meaning more fatigue." (NCT01384591)
Timeframe: Baseline
| Intervention | units on a scale (Mean) |
|---|
| Placebo Losartan and Placebo N-acetylcysteine | 0.5 |
| N-acetylcysteine and Placebo Losartan | 0 |
| Losartan and Placebo N-acetylcysteine | 4 |
Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Emotional Fatigue After All Doses of Study Intervention
"Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue.~There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score.~The range of the emotional fatigue scale is 24 to 0, with the higher number meaning more fatigue.~The range of the total score is -24 to 96, with the higher the number meaning more fatigue." (NCT01384591)
Timeframe: Post dose three of the intervention, average of 17 hours post dose one intervention
| Intervention | units on a scale (Mean) |
|---|
| Placebo Losartan and Placebo N-acetylcysteine | 0.5 |
| N-acetylcysteine and Placebo Losartan | 0 |
| Losartan and Placebo N-acetylcysteine | 7.5 |
Perceptual Fatigue of Whole Body as Measured by Visual Analog Scale Before Handgrip Fatigue Test at Baseline.
"The Visual Analog Scale for Fatigue is an 11cm long line. The subject is asked to mark their level of fatigue (0cm being no fatigue and 11cm being extreme fatigue). This test was performed before and after the handgrip fatigue test, where the non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes.~Handgrip testing was performed at baseline (before any intervention) and post dose three of the intervention, average of 17 hours post dose one intervention." (NCT01384591)
Timeframe: baseline - before handgrip fatigue test
| Intervention | units on a scale (Mean) |
|---|
| Placebo Losartan and Placebo N-acetylcysteine | 0.4 |
| N-acetylcysteine and Placebo Losartan | 1.15 |
| Losartan and Placebo N-acetylcysteine | 0.55 |
Perceptual Fatigue of Whole Body as Measured by Visual Analog Scale Before Handgrip Fatigue Test After Study Intervention
"The Visual Analog Scale for Fatigue is an 11cm long line. The subject is asked to mark their level of fatigue (0cm being no fatigue and 11cm being extreme fatigue). This test was performed before and after the handgrip fatigue test, where the non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes.~Handgrip testing was performed at baseline (before any intervention) and post dose three of the intervention, average of 17 hours post dose one intervention." (NCT01384591)
Timeframe: Post dose three of the intervention, average of 17 hours post dose one intervention - Before handgrip fatigue test
| Intervention | units on a scale (Mean) |
|---|
| Placebo Losartan and Placebo N-acetylcysteine | 0.7 |
| N-acetylcysteine and Placebo Losartan | 4.1 |
| Losartan and Placebo N-acetylcysteine | 0.55 |
Perceptual Fatigue of Whole Body as Measured by Visual Analog Scale After Handgrip Fatigue Test at Baseline.
"The Visual Analog Scale for Fatigue is an 11cm long line. The subject is asked to mark their level of fatigue (0cm being no fatigue and 11cm being extreme fatigue). This test was performed before and after the handgrip fatigue test, where the non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes.~Handgrip testing was performed at baseline (before any intervention) and post dose three of the intervention, average of 17 hours post dose one intervention." (NCT01384591)
Timeframe: baseline - directly after handgrip fatigue test
| Intervention | units on a scale (Mean) |
|---|
| Placebo Losartan and Placebo N-acetylcysteine | 1.05 |
| N-acetylcysteine and Placebo Losartan | 5 |
| Losartan and Placebo N-acetylcysteine | 0.6 |
Urine F2alpha Isoprostanes
Fasting urine F2alpha isoprostane/Cr ratio. Urine isoprostanes were measured by ELISA (Oxford Biomedical Research). (NCT01386645)
Timeframe: 4 weeks
| Intervention | ng/mg (Median) |
|---|
| Low GI Diet | 2.51 |
| High GI Diet Placebo | 3.35 |
| High GI Diet NAC | 3.43 |
Glycemic Variability
Glycemic variability as measured by the standard deviation (SD) of the glucose levels from the iPro continuous glucose monitoring system (CGMS) (NCT01386645)
Timeframe: 4 weeks
| Intervention | mg/dl (Mean) |
|---|
| Low GI Diet | 14.20 |
| High GI Diet Placebo | 19.67 |
| High GI Diet NAC | 17.69 |
Disposition Index
The disposition index generated from an intravenous glucose tolerance test (insulin sensitivity x the acute insulin response to intravenous glucose) is a measure of beta-cell function. (NCT01386645)
Timeframe: 4 weeks
| Intervention | unitless (Median) |
|---|
| Low GI Diet | 708 |
| High GI Diet Placebo | 793 |
| High GI Diet NAC | 791 |
Area Under the Curve for Glucose (AUCg)
Change in AUCg from 0-120 minutes during the oral glucose tolerance test at 4 weeks compared to baseline (NCT01394510)
Timeframe: 4 weeks
| Intervention | mg/dl x 120 minutes (Mean) |
|---|
| N-acetylcysteine Dose Study | -1011 |
Fasting Urine F2 Alpha Isoprostane Levels
Change in fasting urine isoprostane levels at 4 weeks vs baseline as a marker of oxidative stress (NCT01394510)
Timeframe: 4 weeks
| Intervention | ng/ml (Mean) |
|---|
| N-acetylcysteine Dose Study | -0.089 |
Oral Disposition Index
The change in the oral disposition index defined was the change in the early insulin response divided by the change in glucose from 0-30 minutes during the oral glucose tolerance test divided by fasting insulin. (NCT01394510)
Timeframe: 4 weeks
| Intervention | mg/dl (Mean) |
|---|
| N-acetylcysteine Dose Study | -0.08 |
Pulmonary Function Tests
Not recorded. Study terminated due to departure of PI. (NCT01424033)
Timeframe: Every 3 months
| Intervention | () |
|---|
| N-Acetylcysteine | 0 |
Brain GSH
change in brain GSH levels from baseline to post-NAC administration (90 - 110 minutes) in all subjects (NCT01427517)
Timeframe: Baseline and up to 110 minutes post-NAC administration
| Intervention | percent increase from baseline (Mean) |
|---|
| NAC in PD | 55 |
| NAC in GD | 41 |
| NAC in Controls | 34 |
Number of Participants With Serious, Adverse, Patient-Centered Events, Including Death, Need for Acute Dialysis, or Persistent Decline in Kidney Function, Comparing Oral N-Acetylcysteine With Oral Placebo.
Death will be based on medical record and/or vital status registry documentation Need for acute dialysis will be defined as the initiation of any modality of renal replacement (intermittent hemodialysis, peritoneal dialysis, continuous renal replacement therapy, or sustained low-efficiency dialysis) Persistent decline in kidney function will be defined as an increase in serum creatinine of at least 50% from the baseline value collected pre-angiography to the measurement taken 90 days following the angiography. (NCT01467466)
Timeframe: Within 90 days following angiography
| Intervention | Participants (Count of Participants) |
|---|
| N-Acetylcysteine (NAC) | 115 |
| Placebo | 112 |
Number of Participants With Serious, Adverse, Patient-Centered Events, Including Death, Need for Acute Dialysis, or Persistent Decline in Kidney Function, Comparing Intravenous Sodium Bicarbonate With Intravenous Sodium Chloride.
Death will be based on medical record and/or vital status registry documentation Need for acute dialysis will be defined as the initiation of any modality of renal replacement (intermittent hemodialysis, peritoneal dialysis, continuous renal replacement therapy, or sustained low-efficiency dialysis) Persistent decline in kidney function will be defined as an increase in serum creatinine of at least 50% from the baseline value collected pre-angiography to the measurement taken 90 days following the angiography. (NCT01467466)
Timeframe: Within 90 days following angiography
| Intervention | Participants (Count of Participants) |
|---|
| Sodium Bicarbonate | 111 |
| Saline | 116 |
Beck Anxiety Inventory
"The Beck Anxiety Inventory (BAI) is a clinician-administered and validated instrument to discriminate anxiety from depression. The standardized BAI cutoffs are:~0-9: minimal anxiety; 10-16: mild anxiety; 17-29: moderate anxiety; 30-63: severe anxiety." (NCT01470027)
Timeframe: at baseline and 4 weeks after intervention start
| Intervention | units on a scale (Mean) |
|---|
| Baseline | 4 weeks after intervention start |
|---|
| N-acetylcysteine 1800mg - Healthy Volunteer | 3.778 | 2.429 |
,| N-acetylcysteine 1800mg - Parkinson's Patient | 7.000 | 3.000 |
,| N-acetylcysteine 3600mg -Healthy Volunteer | 3.750 | 5.714 |
,| N-acetylcysteine 3600mg -Parkinson's Patient | 9.000 | 8.286 |
,| Placebo -Healthy Volunteer | 2.625 | 4.333 |
,| Placebo -Parkinson's Patient | 6.333 | 5.714 |
9-Hole Peg Board Test (9-HPT)
The 9-HPT is a standardized, quantitative timed test of upper extremity motor function. Individuals are asked to place and remove nine pegs, one at a time, from nine holes in a board as quickly as possible. The task is performed twice with the dominant and twice with the non-dominant hand, and the average time to complete the task once is calculated for each hand. The 9-HPT has a high inter- and intra-rater reliability, is validated and is sensitive to detect minor impairments of hand function. (NCT01470027)
Timeframe: at baseline and 4 weeks after intervention start
| Intervention | s (in seconds) (Mean) |
|---|
| Baseline | 4 weeks after intervention start |
|---|
| N-acetylcysteine 1800mg - Healthy Volunteer | 25.088 | 24.940 |
,| N-acetylcysteine 1800mg - Parkinson's Patient | 37.026 | 32.756 |
,| N-acetylcysteine 3600mg -Healthy Volunteer | 24.593 | 22.511 |
,| N-acetylcysteine 3600mg -Parkinson's Patient | 27.795 | 25.980 |
,| Placebo -Healthy Volunteer | 25.834 | 24.704 |
,| Placebo -Parkinson's Patient | 28.694 | 28.084 |
10-Meter Walk Test
"The 10-meter walk test is a standardized, quantitative timed test of lower body motor function. The maximal gait speed is measured during a 10-meter walk. The task will be performed three times and the average time to complete the task once will be recorded. The 10-meter walk test is a reliable and sensitive measure of gait function in elderly individuals and PD patients.~Cut-off values:~< 0.4 m/s more likely to be household ambulators; 0.4 - 0.8 m/s limited community ambulators; > 0.8 m/s community ambulators." (NCT01470027)
Timeframe: at baseline and 4 weeks after intervention start
| Intervention | m/s (meters per second) (Mean) |
|---|
| Baseline | 4 weeks after intervention start |
|---|
| N-acetylcysteine 1800mg - Healthy Volunteer | 7.253 | 7.279 |
,| N-acetylcysteine 1800mg - Parkinson's Patient | 7.816 | 10.513 |
,| N-acetylcysteine 3600mg -Healthy Volunteer | 10.403 | 9.740 |
,| N-acetylcysteine 3600mg -Parkinson's Patient | 7.289 | 7.434 |
,| Placebo -Healthy Volunteer | 7.141 | 6.893 |
,| Placebo -Parkinson's Patient | 6.896 | 6.296 |
Parkinson's Disease Quality of Life Questionnaire (PDQLQ)
"The Parkinson's Disease Quality of Life Questionnaire is a self completion PRO designed to address aspects of functioning and well-being for those affected by Parkinson's disease.~The Parkinson's Disease Quality of Life Questionnaire is coded on a scale of 0 to 185, with 185 indicating perfect health and 0 indicating very poor health." (NCT01470027)
Timeframe: at baseline and 4 weeks after intervention start
| Intervention | units on a scale (Mean) |
|---|
| Baseline | 4 weeks after intervention start |
|---|
| N-acetylcysteine 1800mg - Healthy Volunteer | 175.667 | 177.833 |
,| N-acetylcysteine 1800mg - Parkinson's Patient | 134.333 | 127.100 |
,| N-acetylcysteine 3600mg -Healthy Volunteer | 171.625 | 165.142 |
,| N-acetylcysteine 3600mg -Parkinson's Patient | 142.285 | 135.571 |
,| Placebo -Healthy Volunteer | 175.250 | 181.750 |
,| Placebo -Parkinson's Patient | 159.833 | 159.429 |
Unified Parkinson's Disease Rating Scale (UPDRS) Parts I-V (Total Score Reported)
"The UPDRS is considered the gold standard for determining disease severity and progression in patients with Parkinson's disease. It consists of the following five elements:~Evaluation of mentation, behavior and mood.~Self evaluation of the activities of daily living (ADLs) including speech, swallowing, handwriting, dressing, hygiene, falling, salivating, etc.~Motor evaluation by a clinician.~Hoehn and Yahr scale (Hoehn 1967) for the description of the overall disease severity in PD with 8 stages.~Schwab and England activities of daily living scale (Schwab and England 1969) for the estimation of the general abilities in PD patients. The Schwab and England ADL scale is graduated in 10% steps with 100% indicating complete independence and 0% indicating an individual in whom the vegetative functions are completely impaired.~A total of 199 points are possible for UPDRS, with 199 representing the worst disability and 0 no disability." (NCT01470027)
Timeframe: at baseline and 4 weeks after intervention start
| Intervention | units on a scale (Mean) |
|---|
| Baseline | 4 weeks after intervention start |
|---|
| N-acetylcysteine 1800mg - Healthy Volunteer | 1.000 | 0.600 |
,| N-acetylcysteine 1800mg - Parkinson's Patient | 35.286 | 23.857 |
,| N-acetylcysteine 3600mg -Healthy Volunteer | 4.500 | 3.000 |
,| N-acetylcysteine 3600mg -Parkinson's Patient | 31.500 | 24.249 |
,| Placebo -Healthy Volunteer | 3.143 | 1.857 |
,| Placebo -Parkinson's Patient | 16.714 | 13.857 |
Mini Mental State Examination (MMSE)
The MMSE is a brief questionnaire-based test that is used to screen for cognitive impairment. Domains tested are orientation to time and place, registration, attention and calculation, recall, language, repetition and complex commands. Scores lower than 25/30 points indicate mild (21-24 points), moderate (10-20 points) or severe (<10 points) cognitive impairment, but scores may need to be corrected for educational attainment, age and interfering impairments such as motor deficits that affect drawing skills. (NCT01470027)
Timeframe: at baseline and 4 weeks after intervention start
| Intervention | units on a scale (Mean) |
|---|
| Baseline | 4 weeks after intervention start |
|---|
| N-acetylcysteine 1800mg - Healthy Volunteer | 29.778 | 29.857 |
,| N-acetylcysteine 1800mg - Parkinson's Patient | 29.571 | 29.667 |
,| N-acetylcysteine 3600mg -Healthy Volunteer | 29.625 | 30.000 |
,| N-acetylcysteine 3600mg -Parkinson's Patient | 29.857 | 29.714 |
,| Placebo -Healthy Volunteer | 30.000 | 29.750 |
,| Placebo -Parkinson's Patient | 29.571 | 30.000 |
Hamilton Depression Rating Scale (HAM-D)
"The Hamilton Depression Rating Scale (HAM-D) is a 21-item instrument designed to measure the severity of illness in adults already diagnosed as having depression. The Hamilton Depression Rating Scale (HAM-D) has proven useful for many years as a way of determining a patient's level of depression before, during, and after treatment. It is clinician-administered and requires 15 to 20 minutes complete the interview and score the results. Although the HAM-D form lists 21 items, the scoring is based on the first 17. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2.~The minimum score is 0 and maximum score is 50. The scale has been widely used in clinical practice and become a standard in pharmaceutical trials.~HAM-D Scoring Instructions are following:~0-7 = Normal; 8-13 = Mild Depression; 14-18 = Moderate Depression; 19-22 = Severe Depression;~≥ 23 = Very Severe Depression." (NCT01470027)
Timeframe: at baseline and 4 weeks after intervention start
| Intervention | units on a scale (Mean) |
|---|
| Baseline | 4 weeks after intervention start |
|---|
| N-acetylcysteine 1800mg - Healthy Volunteer | 2.222 | 1.286 |
,| N-acetylcysteine 1800mg - Parkinson's Patient | 3.714 | 4.167 |
,| N-acetylcysteine 3600mg -Healthy Volunteer | 1.875 | 0.714 |
,| N-acetylcysteine 3600mg -Parkinson's Patient | 3.571 | 3.857 |
,| Placebo -Healthy Volunteer | 1.889 | 1.222 |
,| Placebo -Parkinson's Patient | 1.857 | 1.714 |
Change of Cerebral Glutathione Levels as Measured by Proton Magnetic Resonance Spectroscopy
"In vivo brain GSH measured with 1H MRS in the unmedicated patients with idiopathic PD and in sex- and age-matched healthy controls prior to and following 4 weeks supplementation with either placebo, 1800mg/day or 3600 mg/day of NAC. Striatal and occipital cortex glutathione levels as measured in vivo by 1H MRS at baseline and following 4 weeks of treatment with placebo, 1800mg NAC/day and 3600mg NAC/day.~The area under the GSH spectral peak was obtained by frequency-domain fitting of the GSH resonance in the edited spectrum to a pseudo-Voigt lineshape function using a robust and highly optimized public-domain Levenberg-Marquardt nonlinear least-squares minimization routine. The resulting peak areas were then expressed as ratios relative to the synchronously acquired and similarly fitted unsuppressed voxel water signal." (NCT01470027)
Timeframe: at baseline and 4 weeks after intervention start
| Intervention | Ratio (Mean) |
|---|
| Baseline ( In Striatum) | 4 weeks after intervention start ( In Striatum) | Baseline ( In Occipital) | 4 weeks after intervention start ( In Occipital) |
|---|
| N-acetylcysteine 1800mg - Healthy Volunteer | 4.282 | 4.843 | 2.190 | 2.161 |
,| N-acetylcysteine 1800mg - Parkinson's Patient | 3.422 | 3.404 | 1.743 | 1.962 |
,| N-acetylcysteine 3600mg -Healthy Volunteer | 4.415 | 3.900 | 2.007 | 1.990 |
,| N-acetylcysteine 3600mg -Parkinson's Patient | 3.334 | 3.473 | 1.938 | 2.108 |
,| Placebo -Healthy Volunteer | 3.901 | 3.831 | 2.001 | 2.298 |
,| Placebo -Parkinson's Patient | 3.745 | 4.105 | 1.799 | 2.118 |
Serum T3 Levels at 48 Hours
(NCT01501110)
Timeframe: 48 hours
| Intervention | ng/dL (Mean) |
|---|
| N-acetylcysteine | 93.5 |
| no Intervention | 96.5 |
Retention as Assessed by Number of Participants Who Completed the Study
(NCT01537926)
Timeframe: from baseline to 12 months
| Intervention | Participants (Count of Participants) |
|---|
| N-acetylcysteine (NAC) | 24 |
| Placebo | 11 |
Interventricular Septal Thickness (IVST) as Assessed by Echocardiography
(NCT01537926)
Timeframe: 12 months
| Intervention | millimeters (mm) (Mean) |
|---|
| N-acetylcysteine (NAC) | 17.92 |
| Placebo | 17.82 |
Interventricular Septal Thickness (IVST) as Assessed by Echocardiography
(NCT01537926)
Timeframe: baseline
| Intervention | millimeters (mm) (Mean) |
|---|
| N-acetylcysteine (NAC) | 18.88 |
| Placebo | 18.00 |
Left Ventricular End-systolic Diameter (LVESD) as Assessed by Echocardiography
(NCT01537926)
Timeframe: 12 months
| Intervention | millimeters (mm) (Mean) |
|---|
| N-acetylcysteine (NAC) | 21.88 |
| Placebo | 21.55 |
Left Ventricular End-systolic Diameter (LVESD) as Assessed by Echocardiography
(NCT01537926)
Timeframe: baseline
| Intervention | millimeters (mm) (Mean) |
|---|
| N-acetylcysteine (NAC) | 22.13 |
| Placebo | 22.64 |
Left Ventricular Mass (LVM) as Assessed by Echocardiography
Left Ventricular Mass (LVM) is the weight of the left heart and is estimated from the echocardiographic measurements that include left ventricular wall thickness and the chamber diameter. The weight is calculated in grams and then normalized to body surface area (m^2), with LVM reported as g/m^2. (NCT01537926)
Timeframe: 12 months
| Intervention | g/m^2 (Mean) |
|---|
| N-acetylcysteine (NAC) | 281.98 |
| Placebo | 290.44 |
Left Ventricular Mass (LVM) as Assessed by Echocardiography
Left Ventricular Mass (LVM) is the weight of the left heart and is estimated from the echocardiographic measurements that include left ventricular wall thickness and the chamber diameter. The weight is calculated in grams and then normalized to body surface area (m^2), with LVM reported as g/m^2. (NCT01537926)
Timeframe: baseline
| Intervention | g/m^2 (Mean) |
|---|
| N-acetylcysteine (NAC) | 269.65 |
| Placebo | 292.80 |
Number of Participants With Side Effects Attributable to the Intervention
(NCT01537926)
Timeframe: from baseline to 12 months
| Intervention | Participants (Count of Participants) |
|---|
| N-acetylcysteine (NAC) | 0 |
| Placebo | 0 |
Recruitment as Assessed by Number of Participants Who Enrolled to the Study
(NCT01537926)
Timeframe: at the time of enrollment
| Intervention | Participants (Count of Participants) |
|---|
| N-acetylcysteine (NAC) | 29 |
| Placebo | 13 |
Compliance as Assessed by Percentage of Pills Taken by Participant
Participants returned all pill bottles to the study team, and the number of pills not taken by the participant (that is, the number of pills remaining in the bottles) were counted. Compliance is reported as percentage of pills taken by the participant. (NCT01537926)
Timeframe: from baseline to 12 months
| Intervention | percentage of pills taken (Mean) |
|---|
| All Participants | 92 |
Bronchoalveolar Lavage (BAL) Cell Glutathione (GSH) Levels
We measured changes at baseline and at 8 weeks in BAL whole cell total GSH levels and cellular 8-OHdG before and after treatment with NAC/placebo. (NCT01587001)
Timeframe: 8 weeks of anti-oxidant therapy
| Intervention | nmol/mg protein (Mean) |
|---|
| Baseline visit | 8 week visit |
|---|
| Matching Placebo | 9.39 | 4.28 |
,| Oral N-acetyl-cysteine | 5.93 | 9.42 |
Bronchoalveolar Lavage (BAL) and Peripheral Blood Mononuclear Cells (PBMC) TNF-α Levels
Baseline peripheral blood mononuclear cells and bronchoalveolar lavage (BAL) lymphocyte percentages and lipopolysaccharide (LPS) stimulated tumor necrosis factor-α levels (pg/ml) (NCT01587001)
Timeframe: 8 weeks of anti-oxidant therapy
| Intervention | pg/ml (Mean) |
|---|
| Mean baseline BAL cell TNF-a | Mean follow-up BAL cell TNF-a | Mean baseline PBMC cell TNF-a | Mean follow-up PBMC cell TNF-a |
|---|
| Matching Placebo | 39938 | 25671 | 637 | 969 |
,| Oral N-acetyl-cysteine | 40767 | 45176 | 2775 | 3387 |
Transcriptional Markers of UV-induced Oxidative Stress in Nevi
Biomarkers susceptible to UV-induced damage protected by NAC (N-acetylcysteine) in irradiated and unirradiated nevi (NCT01612221)
Timeframe: 3.5 years
| Intervention | markers of UV-induced oxidative stress (Mean) |
|---|
| GCLM Biomarker | SLC1A4 Biomarker | SLC7A11 Biomarker |
|---|
| Patients Receiving N-acetylcysteine | 8.99 | 9.29 | 8.73 |
,| Placebo Group | 9.14 | 9.40 | 9.03 |
UV-induced Oxidative Stress in Irradiated and Unirradiated Nevi
Differences in the median percent nevus with 8-OG expression in UV-irradiated nevi compares with unirradiated nevi. (NCT01612221)
Timeframe: 3.5 years
| Intervention | percentage of 8-OG expression in nevi (Mean) |
|---|
| UV Irradiated | Unirradiated |
|---|
| Patients Receiving N-acetylcysteine | 94.6 | 33.6 |
,| Placebo Group | 96.2 | 33.1 |
The Odds of Negative Urine Cannabinoid Tests During Treatment.
The primary outcome is the abstinence rate over the 12 weeks of treatment. Abstinence is based on a weekly urine drug screen confirmed by central laboratory testing and defined as a negative cannabinoid result. (NCT01675661)
Timeframe: study weeks 2-13
| Intervention | cannabis negative urine tests (Number) |
|---|
| Study Week 2 | Study Week 3 | Study Week 4 | Study Week 5 | Study Week 6 | Study Week 7 | Study Week 8 | Study Week 9 | Study Week 10 | Study Week 11 | Study Week 12 | Study Week 13 | Overall |
|---|
| NAC Plus CM | 25 | 30 | 33 | 32 | 32 | 36 | 40 | 39 | 39 | 38 | 34 | 33 | 410 |
,| Placebo Plus CM | 21 | 22 | 36 | 33 | 30 | 37 | 37 | 36 | 37 | 36 | 40 | 36 | 401 |
Changes in the Saint George's Respiratory Questionnaire
The St. George's Respiratory Questionnaire (SGRQ) is scored on a scale of 1 to 100 with 100 representing the worst respiratory health status. The instrument is self-administered at baseline and again after 8-weeks of treatment. (NCT01739790)
Timeframe: Baseline to 8 weeks
| Intervention | units on a scale (Mean) |
|---|
| Change in SGRQ Symptoms | Change in SGRQ Activity | Change in SGRQ Impact | Change in SGRQ Total |
|---|
| N-Acetylcysteine | -3.5 | -4.0 | -4.5 | -3.9 |
,| Placebo | -9.8 | -3.7 | -7.5 | -7.1 |
Number of Patients Demonstrating a > 50% Decrease in Depression Scores on the Montgomery-Åsberg Depression Rating Scale (MADRS)
The MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. A higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The questionnaire includes questions on the following symptoms: 1. Apparent sadness; 2. Reported sadness; 3. Inner tension; 4. Reduced sleep; 5. Reduced appetite; 6. Concentration difficulties; 7. Lassitude; 8. Inability to feel; 9. Pessimistic thoughts; and 10. Suicidal thoughts. (NCT01797575)
Timeframe: Received drug for 8 weeks during week 0 to week 8 of the study
| Intervention | Participants (Count of Participants) |
|---|
| Aspirin and NAC | 3 |
| Aspirin | 2 |
| N-Acetyl Cysteine (NAC) | 5 |
| Placebo | 6 |
Number of Patients Demonstrating a > 30% Decrease in Depression Scores on the Montgomery-Åsberg Depression Rating Scale (MADRS)
The MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. A higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The questionnaire includes questions on the following symptoms: 1. Apparent sadness; 2. Reported sadness; 3. Inner tension; 4. Reduced sleep; 5. Reduced appetite; 6. Concentration difficulties; 7. Lassitude; 8. Inability to feel; 9. Pessimistic thoughts; and 10. Suicidal thoughts. This 30% MADRS reduction was analyzed in addition to initial outcome measures of 50% MADRS reduction due to the smaller than expected study sample size. (NCT01797575)
Timeframe: Received drug for 8 weeks during week 9 to week 16 of the study
| Intervention | Participants (Count of Participants) |
|---|
| Aspirin and NAC | 4 |
| Aspirin | 3 |
| N-Acetyl Cysteine (NAC) | 3 |
| Placebo | 4 |
Number of Patients Demonstrating a > 30% Decrease in Depression Scores on the Montgomery-Åsberg Depression Rating Scale (MADRS)
The MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. A higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The questionnaire includes questions on the following symptoms: 1. Apparent sadness; 2. Reported sadness; 3. Inner tension; 4. Reduced sleep; 5. Reduced appetite; 6. Concentration difficulties; 7. Lassitude; 8. Inability to feel; 9. Pessimistic thoughts; and 10. Suicidal thoughts. This 30% MADRS reduction was analyzed in addition to initial outcome measures of 50% MADRS reduction due to the smaller than expected study sample size. (NCT01797575)
Timeframe: Received drug for 8 weeks during week 0 to week 8 of the study
| Intervention | Participants (Count of Participants) |
|---|
| Aspirin and NAC | 3 |
| Aspirin | 2 |
| N-Acetyl Cysteine (NAC) | 6 |
| Placebo | 7 |
Inflammation as Indicated by Interleukin 6 (IL-6) Levels
Interleukin 6 (IL-6) is an interleukin that acts as a pro-inflammatory cytokine and an anti-inflammatory myokine. IL-6 is measured in picograms (pg) per milliliter (mL). Elevated interleukin-6 indicates potential immune system dysregulation and increased inflammation. (NCT01797575)
Timeframe: baseline, week 8, week 16
| Intervention | picograms per milliliter (Mean) |
|---|
| IL-6 at Baseline | IL-6 at Week 8 | IL-6 at Week 16 |
|---|
| Aspirin | 1.27 | .78 | .90 |
,| Aspirin and NAC | .85 | 1.76 | 1.72 |
,| N-acetyl-cysteine | 3.22 | 3.53 | 2.6 |
,| Sugar Pill | 2.3 | 1.87 | 1.71 |
Inflammation as Indicated by C-reactive Protein (CRP) Levels
C-reactive protein (CRP) levels are blood test markers of inflammation. Higher CRP corresponds with higher levels of inflammation. CRP is measured in milligrams per liter. (NCT01797575)
Timeframe: baseline, week 8, week 16
| Intervention | milligrams per liter (Mean) |
|---|
| CRP at Baseline | CRP at Week 8 | CRP at Week 16 |
|---|
| Aspirin | 6.85 | 6.82 | 10.76 |
,| Aspirin and NAC | 5.1 | 17.02 | 9.39 |
,| N-acetyl-cysteine | 17.65 | 41.09 | 17.69 |
,| Sugar Pill | 17.30 | 7.4 | 13.10 |
Number of Patients Demonstrating a > 50% Decrease in Depression Scores on the Montgomery-Åsberg Depression Rating Scale (MADRS)
The MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. A higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The questionnaire includes questions on the following symptoms: 1. Apparent sadness; 2. Reported sadness; 3. Inner tension; 4. Reduced sleep; 5. Reduced appetite; 6. Concentration difficulties; 7. Lassitude; 8. Inability to feel; 9. Pessimistic thoughts; and 10. Suicidal thoughts. (NCT01797575)
Timeframe: Received drug for 8 weeks during week 9 to week 16 of the study
| Intervention | Participants (Count of Participants) |
|---|
| Aspirin and NAC | 3 |
| Aspirin | 1 |
| N-Acetyl Cysteine (NAC) | 3 |
| Placebo | 4 |
Stress
Stress will be measured by the Perceived Stress Scale ((PSS), a 10-item instrument for measuring the perception of stress, with total scores ranging from 0-40. Higher scores = higher perceived stress (NCT01840345)
Timeframe: Baseline, 4 weeks
| Intervention | units on a scale (Mean) |
|---|
| Baseline | 4 weeks |
|---|
| N-acetyl-L-cysteine | 21.5 | 16.6 |
Pain
"Pain intensity will be measured by using the 100-point Visual Analogue Scale, a 100-mm horizontal line with anchors of no pain at all (at 0) and worst pain imaginable (at 100mm) on which patients' pain intensities are measured." (NCT01840345)
Timeframe: Baseline, 4 weeks
| Intervention | mm on 100 mm scale (Mean) |
|---|
| Baseline | 4 weeks |
|---|
| N-acetyl-L-cysteine | 6.38 | 5.95 |
Opioid Use
The amount of opioid medication used was recorded. Then, it was converted to morphine equivalents (https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/Downloads/Opioid-Morphine-EQ-Conversion-Factors-March-2015.pdf). Opioid use was measured over a 2-week baseline period. Then, the average opioid medication use/week was calculated. This was compared to the average opioid medication use/week after 4 weeks of NAC. (NCT01840345)
Timeframe: Baseline, 4 weeks
| Intervention | morphine equivalent dose (Mean) |
|---|
| Baseline | 4 weeks |
|---|
| N-acetyl-L-cysteine | 101.24 | 104.56 |
Mood
Mood will be assessed by using the Patient Health Questionnaire (PHQ-9), a validated 9-question assessment of depression with total scores ranging from 0-27. Higher score = worse depression. (NCT01840345)
Timeframe: Baseline, 4 weeks
| Intervention | units on a scale (Mean) |
|---|
| Baseline | 4 weeks |
|---|
| N-acetyl-L-cysteine | 10.4 | 9.7 |
Change in Circulating F2-isoprostane Levels
Oxidative stress measure (NCT01962961)
Timeframe: Baseline and 8 weeks
| Intervention | pg/mL (Mean) |
|---|
| PharmaNAC 1800 mg | -12.78 |
| PharmaNAC 3600 mg | -4.84 |
| Placebo | 11.76 |
Change in Circulating Malondialdehyde Levels
Measure of oxidative stress (NCT01962961)
Timeframe: Baseline and 8 weeks
| Intervention | micromolar (Mean) |
|---|
| PharmaNAC 1800 mg | 0.17 |
| PharmaNAC 3600 mg | -0.12 |
| Placebo | -0.00 |
Measurement of Nail Length
Length of nails, measured by caliper (NCT01993849)
Timeframe: End of 8-week treatment
| Intervention | millimeters (Mean) |
|---|
| N-Acetylcysteine | 10.12 |
| Placebo | 10.73 |
Number of Participants Enrolled Within One Year
Ability to enroll the goal sample within one year; we are interested in the feasibility of sufficient enrollment and data collection within a given period of time. (NCT01993849)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|
| N-Acetylcysteine (NAC) | 12 |
| Placebo | 11 |
Change in Percentage of Predicted Forced Expiratory Volume in One Second (FEV1%) From Baselines
The change was calculated from two time points as the value at the later time point minus the value at the earlier time point. (NCT02088216)
Timeframe: 12 months
| Intervention | percentage of predicted FEV1 (Mean) |
|---|
| N-acetylcysteine Group | 1.16 |
| Control Group | 0.13 |
Change of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) Scores From Baselines
"Chronic Obstructive Pulmonary Disease Assessment Test (CAT) scores: the minimum value is 0 and the maximum value is 40.~0-10 points: slight impact; 11-20 points: medium impact; 21-30 points: serious impact; 31-40 points: very serious impact.~The change was calculated from two time points as the value at the later time point minus the value at the earlier time point." (NCT02088216)
Timeframe: 12 months
| Intervention | score on a scale (Mean) |
|---|
| N-acetylcysteine Group | -3.79 |
| Control Group | -1.44 |
Change of Volume of Sputum From Baseline Parameters After the 12-month Follow-up.
The change was calculated from two time points as the value at the later time point minus the value at the earlier time point. (NCT02088216)
Timeframe: 12 months
| Intervention | mL (Mean) |
|---|
| N-acetylcysteine Group | -6.46 |
| Control Group | -18.28 |
Time to Recurrent Exacerbations
(NCT02088216)
Timeframe: 12 months
| Intervention | days (Mean) |
|---|
| N-acetylcysteine Group | 313.70 |
| Control Group | 266.88 |
Time to the First Exacerbation
(NCT02088216)
Timeframe: 12 months
| Intervention | days (Median) |
|---|
| N-acetylcysteine Group | 140 |
| Control Group | 115 |
Adverse Events (AEs) (Elevation of Liver Enzymes)
(NCT02088216)
Timeframe: 12 months
| Intervention | Participants (Count of Participants) |
|---|
| N-acetylcysteine Group | 3 |
| Control Group | 0 |
Nature of Sputum (Number of Patients With Yellow Purulent)
(NCT02088216)
Timeframe: 12 months
| Intervention | Participants (Count of Participants) |
|---|
| N-acetylcysteine Group | 12 |
| Control Group | 31 |
Change of Forced Vital Capacity (FVC) From Baselines
The change was calculated from two time points as the value at the later time point minus the value at the earlier time point. (NCT02088216)
Timeframe: 12 months
| Intervention | L (Mean) |
|---|
| N-acetylcysteine Group | 0.01 |
| Control Group | 0.03 |
Change of Forced Expiratory Volume in One Second (FEV1) (L) From Baselines
The change was calculated from two time points as the value at the later time point minus the value at the earlier time point. (NCT02088216)
Timeframe: 12 months
| Intervention | L (Mean) |
|---|
| N-acetylcysteine Group | -0.10 |
| Control Group | 0.03 |
Change of Number of Patients With a Positive Sputum Culture for Pseudomonas Aeruginosa
The values in the table were calculated as the value at baseline minus the value at 12 months. (NCT02088216)
Timeframe: 12 months
| Intervention | Participants (Count of Participants) |
|---|
| N-acetylcysteine Group | 8 |
| Control Group | 5 |
EORTC Quality of Life Questionnaire (QLQ) H&N Sticky Saliva AUC
Average Area Under the Curve per assessment (aAUCpa) of QLQ H&N35 subscales including pain, swallowing, teeth, opening mouth, dry mouth, sticky saliva, senses problems, coughing, speech problems, felt ill, trouble with social contact, trouble with social eating, less sexuality, pain killers, nutritional supplements, feeding tube, weight loss, & weight gain. The QLQ H&N35 scoring algorithm was used for sticky saliva (question 42) on 0-100 scales with higher scores representing worse symptoms. The aAUCpa for each subscale is calculated as the average of each AUC between each sequential assessment from treatment-initiation to the end of radiotherapy. For example; for each patient & subscale, the subscale values at treatment-initiation & assessment-1 are used to calculate an Area Under the Curve (AUC) for that assessment time-period. Then these AUCs for all available assessment time-periods up to the end of their radiotherapy are averaged to yield the aAUCpa per patient per subscale. (NCT02123511)
Timeframe: Up to 90 days after completion of radiation therapy
| Intervention | score on a scale (Mean) |
|---|
| Arm A (Placebo) | 46.3 |
| Arm B (Rincinol) | 37.9 |
GRIX Xerostomia Nighttime AUC
GRIX Xerostomia Nighttime AUC. The GRIX questionnaire is a 14-item questionnaire with four subscales on 0-100 scales with higher scores representing worse symptoms. The aAUCpa for each subscale is calculated as the average of each AUC between each sequential assessment from treatment-initiation to the end of radiotherapy. For example; for each patient and each subscale, the subscale values at treatment-initiation and assessment-1 are used to calculate an Area Under the Curve (AUC) for that assessment time-period. Then these AUCs for all available assessment time-periods up to the end of their radiotherapy are averaged to yield the aAUCpa per patient per subscale. AUC will be calculated for each patient from baseline to two weeks following radiotherapy. The AUC values will be compared between the two arms using t-test (equal variance). (NCT02123511)
Timeframe: Up to 90 days after completion of radiation therapy
| Intervention | score on a scale (Mean) |
|---|
| Arm A (Placebo) | 39.8 |
| Arm B (Rincinol) | 31.3 |
EORTC Quality of Life Questionnaire (QLQ) H&N Pain AUC
Average Area Under the Curve per assessment (aAUCpa) of QLQ H&N35 subscales including pain, swallowing, teeth, opening mouth, dry mouth, sticky saliva, senses problems, coughing, speech problems, felt ill, trouble with social contact, trouble with social eating, less sexuality, pain killers, nutritional supplements, feeding tube, weight loss, and weight gain. The QLQ H&N35 scoring algorithm was used for pain (questions 31-34) on 0-100 scales with higher scores representing worse symptoms. The aAUCpa for each subscale is calculated as the average of each AUC between each sequential assessment from treatment-initiation to the end of radiotherapy. For example; for each patient and subscale, the subscale values at treatment-initiation and assessment-1 are used to calculate an Area Under the Curve (AUC) for that assessment time-period. Then these AUCs for all available assessment time-periods up to the end of their radiotherapy are averaged to yield the aAUCpa per patient per subscale. (NCT02123511)
Timeframe: Up to 90 days after completion of radiation therapy
| Intervention | score on a scale (Mean) |
|---|
| Arm A (Placebo) | 32.4 |
| Arm B (Rincinol) | 32.0 |
EORTC Quality of Life Questionnaire (QLQ) Swallowing
Average Area Under the Curve per assessment (aAUCpa) of QLQ H&N35 subscales including pain, swallowing, teeth, opening mouth, dry mouth, sticky saliva, senses problems, coughing, speech problems, felt ill, trouble with social contact, trouble with social eating, less sexuality, pain killers, nutritional supplements, feeding tube, weight loss, & weight gain. The QLQ H&N35 scoring algorithm was used for swallowing (questions 35-38) on 0-100 scales with higher scores representing worse symptoms. The aAUCpa for each subscale is calculated as the average of each AUC between each sequential assessment from treatment-initiation to the end of radiotherapy. For example; for each patient & subscale, the subscale values at treatment-initiation & assessment-1 are used to calculate an Area Under the Curve (AUC) for that assessment time-period. Then these AUCs for all available assessment time-periods up to the end of their radiotherapy are averaged to yield the aAUCpa per patient per subscale. (NCT02123511)
Timeframe: Up to 90 days after completion of radiation therapy
| Intervention | score on a scale (Mean) |
|---|
| Arm A (Placebo) | 34.7 |
| Arm B (Rincinol) | 22.3 |
Groningen Radiotherapy-Induced Xerostomia (GRIX) Sticky Saliva Nighttime Area Under the Curve (AUC).
Groningen Radiotherapy-Induced Xerostomia (GRIX) sticky saliva Nighttime Area under the curve (AUC).The GRIX questionnaire is a 14-item questionnaire with four subscales on 0-100 scales with higher scores representing worse symptoms. The aAUCpa for each subscale is calculated as the average of each AUC between each sequential assessment from treatment-initiation to the end of radiotherapy. For example; for each patient and each subscale, the subscale values at treatment-initiation and assessment-1 are used to calculate an Area Under the Curve (AUC) for that assessment time-period. Then these AUCs for all available assessment time-periods up to the end of their radiotherapy are averaged to yield the aAUCpa per patient per subscale. AUC will be calculated for each patient from baseline to two weeks following radiotherapy. The AUC values will be compared between the two arms using t-test (equal variance). (NCT02123511)
Timeframe: Up to 90 days after completion of radiation therapy
| Intervention | score on a scale (Mean) |
|---|
| Arm A (Placebo) | 34.5 |
| Arm B (Rincinol) | 29.1 |
GRIX Xerostiomia Total Score AUC
GRIX Xerostiomia Total Score AUC. The GRIX questionnaire is a 14-item questionnaire with four subscales on 0-100 scales with higher scores representing worse symptoms. The aAUCpa for each subscale is calculated as the average of each AUC between each sequential assessment from treatment-initiation to the end of radiotherapy. For example; for each patient and each subscale, the subscale values at treatment-initiation and assessment-1 are used to calculate an Area Under the Curve (AUC) for that assessment time-period. Then these AUCs for all available assessment time-periods up to the end of their radiotherapy are averaged to yield the aAUCpa per patient per subscale. AUC will be calculated for each patient from baseline to two weeks following radiotherapy. The AUC values will be compared between the two arms using t-test (equal variance). (NCT02123511)
Timeframe: Up to 90 days after completion of radiation therapy
| Intervention | score on a scale (Mean) |
|---|
| Arm A (Placebo) | 43.8 |
| Arm B (Rincinol) | 28.5 |
GRIX Xerostomia Daytime AUC
GRIX Xerostomia Daytime AUC. The GRIX questionnaire is a 14-item questionnaire with four subscales on 0-100 scales with higher scores representing worse symptoms. The aAUCpa for each subscale is calculated as the average of each AUC between each sequential assessment from treatment-initiation to the end of radiotherapy. For example; for each patient and each subscale, the subscale values at treatment-initiation and assessment-1 are used to calculate an Area Under the Curve (AUC) for that assessment time-period. Then these AUCs for all available assessment time-periods up to the end of their radiotherapy are averaged to yield the aAUCpa per patient per subscale. AUC will be calculated for each patient from baseline to two weeks following radiotherapy. The AUC values will be compared between the two arms using t-test (equal variance). (NCT02123511)
Timeframe: Up to 90 days after completion of radiation therapy
| Intervention | score on a scale (Mean) |
|---|
| Arm A (Placebo) | 44.1 |
| Arm B (Rincinol) | 27.3 |
Groningen Radiotherapy-Induced Xerostomia (GRIX) Sticky Saliva Daytime Area Under the Curve (AUC)
Groningen Radiotherapy-Induced Xerostomia (GRIX) sticky saliva Daytime Area under the curve (AUC).The GRIX questionnaire is a 14-item questionnaire with four subscales on 0-100 scales with higher scores representing worse symptoms. The aAUCpa for each subscale is calculated as the average of each AUC between each sequential assessment from treatment-initiation to the end of radiotherapy. For example; for each patient and each subscale, the subscale values at treatment-initiation and assessment-1 are used to calculate an Area Under the Curve (AUC) for that assessment time-period. Then these AUCs for all available assessment time-periods up to the end of their radiotherapy are averaged to yield the aAUCpa per patient per subscale. AUC will be calculated for each patient from baseline to two weeks following radiotherapy. The AUC values will be compared between the two arms using t-test (equal variance). (NCT02123511)
Timeframe: Up to 90 days after completion of radiation therapy
| Intervention | score on a scale (Mean) |
|---|
| Arm A (Placebo) | 45.2 |
| Arm B (Rincinol) | 26.1 |
Groningen Radiotherapy-Induced Xerostomia (GRIX) Sticky Saliva Total Score Area Under the Curve (AUC)
Groningen Radiotherapy-Induced Xerostomia (GRIX) sticky saliva total score Area under the curve (AUC).The GRIX questionnaire is a 14-item questionnaire with four subscales on 0-100 scales with higher scores representing worse symptoms. The aAUCpa for each subscale is calculated as the average of each AUC between each sequential assessment from treatment-initiation to the end of radiotherapy. For example; for each patient and each subscale, the subscale values at treatment-initiation and assessment-1 are used to calculate an Area Under the Curve (AUC) for that assessment time-period. Then these AUCs for all available assessment time-periods up to the end of their radiotherapy are averaged to yield the aAUCpa per patient per subscale. AUC will be calculated for each patient from baseline to two weeks following radiotherapy. The AUC values will be compared between the two arms using t-test (equal variance). (NCT02123511)
Timeframe: Up to 2 weeks following radiotherapy
| Intervention | score on a scale (Mean) |
|---|
| Arm A (Placebo) | 40.9 |
| Arm B (Rincinol) | 27.2 |
Adverse Event, as Measured by the Number of Patients With a Maximum Grade of Any Adverse Event
The maximum grade for each type of toxicity will be recorded for each patient. The overall adverse event rates (percentages) for adverse events are reported below. (NCT02123511)
Timeframe: Up to 90 days after completion of radiation therapy
| Intervention | Participants (Count of Participants) |
|---|
| Missing | Grade 0 | Grade 1 | Grade 2 | Grade 3 |
|---|
| Arm A (Placebo) | 0 | 2 | 3 | 4 | 8 |
,| Arm B (Rincinol) | 1 | 0 | 5 | 6 | 3 |
Peak Diastolic Blood Pressure
Diastolic blood pressure was measured with an automated monitor. Higher values represent greater diastolic pressure. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions. (NCT02141620)
Timeframe: This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.
| Intervention | mm Hg (Mean) |
|---|
| Placebo Cocaine | 30 mg Cocaine | 60 mg Cocaine |
|---|
| n-Acetylcysteine | 74.9 | 82.3 | 79.9 |
,| Placebo | 75.9 | 81.1 | 82.4 |
Peak Heart Rate
Heart rate was measured with an automated monitor. Higher values represent greater heart rate. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions. (NCT02141620)
Timeframe: This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.
| Intervention | beats per minute (Mean) |
|---|
| Placebo Cocaine | 30 mg Cocaine | 60 mg Cocaine |
|---|
| n-Acetylcysteine | 73.6 | 74.9 | 85.4 |
,| Placebo | 72.4 | 82.2 | 84.3 |
Peak Score on Sedative Subscale of the Adjective Rating Scale
"Subjects completed 16 items that loaded into the Sedative Subscale of the Adjective Rating Scale. The items were rated 0-4 on a Likert-type scale and the sum for the 16 sedative items was summed to yield the Sedative Subscale score. The maximum score for this scale was 64, the minimum was 0. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions." (NCT02141620)
Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.
| Intervention | units on a scale (Mean) |
|---|
| Placebo Cocaine | 30 mg Cocaine | 60 mg Cocaine |
|---|
| n-Acetylcysteine | 3.9 | 2.4 | 2.6 |
,| Placebo | 3.8 | 2.5 | 2.6 |
Peak Score on Stimulant Subscale of the Adjective Rating Scale
"Subjects completed 16 items that loaded into the Stimulant Subscale of the Adjective Rating Scale. The items were rated 0-4 on a Likert-type scale and the sum for the 16 sedative items was summed to yield the Stimulant Subscale score. The maximum score for this scale was 64, the minimum was 0. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions." (NCT02141620)
Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.
| Intervention | units on a scale (Mean) |
|---|
| Placebo Cocaine | 30 mg Cocaine | 60 mg Cocaine |
|---|
| n-Acetylcysteine | 5.7 | 9.1 | 11.6 |
,| Placebo | 6.1 | 9.8 | 12.2 |
Peak Systolic Blood Pressure
Systolic blood pressure was measured with an automated monitor. Higher values represent greater systolic pressure. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions. (NCT02141620)
Timeframe: This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.
| Intervention | mm Hg (Mean) |
|---|
| Placebo Cocaine | 30 mg Cocaine | 60 mg Cocaine |
|---|
| n-Acetylcysteine | 117.2 | 128.6 | 127.3 |
,| Placebo | 117.9 | 128.5 | 131.1 |
"Peak Ratings of Active, Alert, Energetic on the Visual Analog Scale"
"Subjects rated their feelings of Active, Alert, Energetic on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions." (NCT02141620)
Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.
| Intervention | units on a scale (Mean) |
|---|
| Placebo Cocaine | 30 mg Cocaine | 60 mg Cocaine |
|---|
| n-Acetylcysteine | .9 | 13.9 | 20.5 |
,| Placebo | 2.4 | 14.7 | 27.1 |
"Peak Ratings of Any Effect on the Visual Analog Scale"
"Subjects rated their feelings of Any Effect on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions." (NCT02141620)
Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.
| Intervention | units on a scale (Mean) |
|---|
| Placebo Cocaine | 30 mg Cocaine | 60 mg Cocaine |
|---|
| n-Acetylcysteine | 1.4 | 16.7 | 28.2 |
,| Placebo | 1.1 | 19.6 | 25.7 |
"Peak Ratings of Bad Effects on the Visual Analog Scale"
"Subjects rated their feelings of Bad Effects on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions." (NCT02141620)
Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.
| Intervention | units on a scale (Mean) |
|---|
| Placebo Cocaine | 30 mg Cocaine | 60 mg Cocaine |
|---|
| n-Acetylcysteine | 1.1 | 3.9 | 7.2 |
,| Placebo | 1.2 | 4.2 | 10.1 |
"Peak Ratings of Euphoric on the Visual Analog Scale"
"Subjects rated their feelings of Euphoric on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions." (NCT02141620)
Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.
| Intervention | units on a scale (Mean) |
|---|
| Placebo Cocaine | 30 mg Cocaine | 60 mg Cocaine |
|---|
| n-Acetylcysteine | 1.1 | 3.1 | 7.9 |
,| Placebo | 2.6 | 9.4 | 15.1 |
"Peak Ratings of Good Effects on the Visual Analog Scale"
"Subjects rated their feelings of Good Effects on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions." (NCT02141620)
Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.
| Intervention | units on a scale (Mean) |
|---|
| Placebo Cocaine | 30 mg Cocaine | 60 mg Cocaine |
|---|
| n-Acetylcysteine | 1.3 | 16.7 | 22.1 |
,| Placebo | 1.1 | 14.8 | 25.3 |
"Peak Ratings of High on the Visual Analog Scale"
"Subjects rated their feelings of High on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions." (NCT02141620)
Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.
| Intervention | units on a scale (Mean) |
|---|
| Placebo Cocaine | 30 mg Cocaine | 60 mg Cocaine |
|---|
| n-Acetylcysteine | 1.4 | 16.9 | 27.1 |
,| Placebo | .9 | 18.2 | 29.3 |
"Peak Ratings of Irregular/Racing Heartbeat on the Visual Analog Scale"
"Subjects rated their feelings of Irregular/Racing Heartbeat on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions." (NCT02141620)
Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.
| Intervention | units on a scale (Mean) |
|---|
| Placebo Cocaine | 30 mg Cocaine | 60 mg Cocaine |
|---|
| n-Acetylcysteine | 1.1 | 5 | 15.6 |
,| Placebo | 1.9 | 8.4 | 13.6 |
"Peak Ratings of Like Drug on the Visual Analog Scale"
"Subjects rated their feelings of Like Drug on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions." (NCT02141620)
Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.
| Intervention | units on a scale (Mean) |
|---|
| Placebo Cocaine | 30 mg Cocaine | 60 mg Cocaine |
|---|
| n-Acetylcysteine | 2.3 | 19.7 | 26.9 |
,| Placebo | 2.4 | 20.8 | 31.7 |
"Peak Ratings of Nauseous on the Visual Analog Scale"
"Subjects rated their feelings of Nauseous on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions." (NCT02141620)
Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.
| Intervention | units on a scale (Mean) |
|---|
| Placebo Cocaine | 30 mg Cocaine | 60 mg Cocaine |
|---|
| n-Acetylcysteine | 3.9 | 1.3 | 7.4 |
,| Placebo | .9 | 2.5 | 8.1 |
"Peak Ratings of Nervous/Anxious on the Visual Analog Scale"
"Subjects rated their feelings of Nervous/Anxious on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions." (NCT02141620)
Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.
| Intervention | units on a scale (Mean) |
|---|
| Placebo Cocaine | 30 mg Cocaine | 60 mg Cocaine |
|---|
| n-Acetylcysteine | .9 | .9 | 9.1 |
,| Placebo | 2.4 | 2.3 | 7.5 |
"Peak Ratings of Performance Impaired on the Visual Analog Scale"
"Subjects rated their feelings of Performance Impaired on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions." (NCT02141620)
Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.
| Intervention | units on a scale (Mean) |
|---|
| Placebo Cocaine | 30 mg Cocaine | 60 mg Cocaine |
|---|
| n-Acetylcysteine | 1.4 | 2.9 | 7 |
,| Placebo | 1.3 | 3.1 | 3.8 |
Peak Temperature
Oral temperature was measured with an automated monitor. Higher values represent greater temperature. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions. (NCT02141620)
Timeframe: This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.
| Intervention | degrees Fahrenheit (Mean) |
|---|
| Placebo Cocaine | 30 mg Cocaine | 60 mg Cocaine |
|---|
| n-Acetylcysteine | 98.3 | 98.3 | 98.3 |
,| Placebo | 98.3 | 98.4 | 98.3 |
"Peak Ratings of Performance Improved on the Visual Analog Scale"
"Subjects rated their feelings of Performance Improved on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions." (NCT02141620)
Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.
| Intervention | units on a scale (Mean) |
|---|
| Placebo Cocaine | 30 mg Cocaine | 60 mg Cocaine |
|---|
| n-Acetylcysteine | .9 | 6.1 | 3.5 |
,| Placebo | 1.5 | 7.3 | 10.1 |
"Peak Ratings of Restless on the Visual Analog Scale"
"Subjects rated their feelings of Restless on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions." (NCT02141620)
Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.
| Intervention | units on a scale (Mean) |
|---|
| Placebo Cocaine | 30 mg Cocaine | 60 mg Cocaine |
|---|
| n-Acetylcysteine | 1.0 | 1.1 | 3.2 |
,| Placebo | 1.0 | 3 | 3.4 |
"Peak Ratings of Rush on the Visual Analog Scale"
"Subjects rated their feelings of Rush on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions." (NCT02141620)
Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.
| Intervention | units on a scale (Mean) |
|---|
| Placebo Cocaine | 30 mg Cocaine | 60 mg Cocaine |
|---|
| n-Acetylcysteine | .9 | 10.8 | 24.8 |
,| Placebo | 1.2 | 12.1 | 24.6 |
"Peak Ratings of Shaky/Jittery on the Visual Analog Scale"
"Subjects rated their feelings of Shaky/Jittery on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions." (NCT02141620)
Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.
| Intervention | units on a scale (Mean) |
|---|
| Placebo Cocaine | 30 mg Cocaine | 60 mg Cocaine |
|---|
| n-Acetylcysteine | 1.3 | 8.1 | 14.7 |
,| Placebo | 2.3 | 6.1 | 14.6 |
"Peak Ratings of Sluggish/Fatigued/Lazy on the Visual Analog Scale"
"Subjects rated their feelings of Sluggish/Fatigued/Lazy on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions." (NCT02141620)
Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.
| Intervention | units on a scale (Mean) |
|---|
| Placebo Cocaine | 30 mg Cocaine | 60 mg Cocaine |
|---|
| n-Acetylcysteine | 1 | 1.6 | 2.1 |
,| Placebo | 1.1 | 1.3 | 4.9 |
"Peak Ratings of Stimulated on the Visual Analog Scale"
"Subjects rated their feelings of Stimulated on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions." (NCT02141620)
Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.
| Intervention | units on a scale (Mean) |
|---|
| Placebo Cocaine | 30 mg Cocaine | 60 mg Cocaine |
|---|
| n-Acetylcysteine | 1.2 | 7.5 | 18.3 |
,| Placebo | 1.1 | 13.7 | 22.1 |
"Peak Ratings of Talkative/Friendly on the Visual Analog Scale"
"Subjects rated their feelings of Talkative/Friendly on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions." (NCT02141620)
Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.
| Intervention | units on a scale (Mean) |
|---|
| Placebo Cocaine | 30 mg Cocaine | 60 mg Cocaine |
|---|
| n-Acetylcysteine | .9 | 11.4 | 14.5 |
,| Placebo | 2.2 | 9.5 | 22.3 |
"Peak Ratings of Willing to Pay For on the Visual Analog Scale"
"Subjects rated their feelings of Willing to Pay For on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions." (NCT02141620)
Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.
| Intervention | units on a scale (Mean) |
|---|
| Placebo Cocaine | 30 mg Cocaine | 60 mg Cocaine |
|---|
| n-Acetylcysteine | 3.6 | 19.2 | 31.3 |
,| Placebo | 2.4 | 21 | 33.9 |
"Peak Ratings of Willing to Take Again on the Visual Analog Scale"
"Subjects rated their feelings of Willing to Take Again on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions." (NCT02141620)
Timeframe: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.
| Intervention | units on a scale (Mean) |
|---|
| Placebo Cocaine | 30 mg Cocaine | 60 mg Cocaine |
|---|
| n-Acetylcysteine | 4.1 | 24.9 | 32.2 |
,| Placebo | 4.2 | 27.6 | 35.4 |
Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative
The reinforcing effects of cocaine were determined using a modified progressive ratio procedure (Stoops et al., 2010) in which subjects made 6 choices between available each available cocaine dose and money (US$0.25). Reinforcing effects are measured for each cocaine dose during both buspirone and placebo maintenance. (NCT02141620)
Timeframe: One test per cocaine dose level per intervention for each participant over his/her approximate 2 week inpatient admission.
| Intervention | Number of Cocaine Choices (Mean) |
|---|
| Placebo Cocaine | 30 mg Cocaine | 60 mg Cocaine |
|---|
| n-Acetylcysteine | 0.1 | 3.9 | 3.9 |
,| Placebo | 1.0 | 3.4 | 3.5 |
Change in Capnography (Vd/Vt)
The deadspace-to-tidal volume (Vd/Vt) ratio is a parameter that is measured in mechanically ventilated patients as a way to assess the severity of gas exchange impairment and to assist in determining whether a patient is ready to be weaned from the ventilator. The change from baseline was measured at 48 hours, with a decreasing ratio indicating improvement. (NCT02168387)
Timeframe: baseline and 48 hours
| Intervention | ratio (Mean) |
|---|
| Medication | -0.04 |
| Continuous High Frequency Oscillator (CHFO) | 0.03 |
Improvement of Atelectasis
"An atelectasis score (AS), as published by Deakins, et al. 2002, was assigned to each radiograph as follows:~0 Complete resolution of collapse~Partial collapse of 1 segment or lobe~Partial collapse of ≥ 2 segments or lobes~Complete collapse of 1 segment or lobe~Complete collapse of ≥ 2 segments or lobes~In the event of inter-rater disagreement, the scores were averaged. Improvement was defined as any decrease in AS ≥ 0.5. Worsening was defined as an increase in AS ≥ 0.5 or escalation of respiratory support modality (i.e. high frequency ventilation)." (NCT02168387)
Timeframe: after 48 hours of therapy
| Intervention | participants (Number) |
|---|
| Improved in 48 h | Worse in 48 hr | No change in 48 hr |
|---|
| Continuous High Frequency Oscillator (CHFO) | 7 | 6 | 3 |
,| Medication | 6 | 3 | 4 |
Difference in Epinephrine Secretion During the Morning Episodes of Hypoglycemia on Days One and Two Under the Two Treatment Conditions
Epinephrine secretion during hypoglycemia is assessed by collecting blood samples for measurement of epinephrine concentrations at baseline and every 15 minutes during the period of hypoglycemia (starting at point where blood glucose is first < 55 mg/dl) in the clamp studies done in the mornings of days 1 and 2 of both parts 1 and 2. . (NCT02206152)
Timeframe: 8-10 weeks
| Intervention | ug/ml (Mean) |
|---|
| Placebo | 622.8 |
| Treatment With N-Acetyl Cysteine | 867 |
Glutathione (GSH) Brain Levels
GSH levels in brain of all subjects at baseline and post-NAC (n-acetylcysteine) dosing as measured by magnetic resonance spectroscopy (MRS) (NCT02212678)
Timeframe: pre-dose and after approximately 28 days of treatment
| Intervention | mM (Mean) |
|---|
| Baseline | Post-NAC |
|---|
| N-acetylcysteine | 0.93 | 0.99 |
Tmax of NAC After Single Dose Administration of Test and Reference
time to achieve the maximum concentration level of the drug in plasma. (NCT02265224)
Timeframe: 0-24h (5,15, 30, 45, 60, 75, 90 min and 2, 3, 4, 6, 8, 12, 16 and 24 h postdose)
| Intervention | hours (Median) |
|---|
| Test | 1.00 |
| Reference | 1.00 |
t1/2 of NAC After Single Dose Administration of Test and Reference
Half-life (t1/2) is the time to halve the plasma concentration level of the drug. (NCT02265224)
Timeframe: 0-24h (5,15, 30, 45, 60, 75, 90 min and 2, 3, 4, 6, 8, 12, 16 and 24 h postdose)
| Intervention | hours (Mean) |
|---|
| Test | 14.11 |
| Reference | 13.59 |
Lambda Zeta of NAC After Single Dose Administration of Test and Reference
Lambda zeta is the terminal elimination rate constant. Individual estimate of the terminal elimination rate constant can be calculated using log-linear regression of the terminal portions of the plasma concentration-versus-time curves. (NCT02265224)
Timeframe: 0-24h (5,15, 30, 45, 60, 75, 90 min and 2, 3, 4, 6, 8, 12, 16 and 24 h postdose)
| Intervention | 1/h (Mean) |
|---|
| Test | 0.05 |
| Reference | 0.05 |
AUC0-∞ of NAC After Single Dose Administration of Test and Reference
AUC0-∞ is the area under the concentration-time curve extrapolated to infinity, calculated, if feasible, as AUC0-t + Ct/λz, where Ct is the last measurable drug concentration. (NCT02265224)
Timeframe: 0-24h (5,15, 30, 45, 60, 75, 90 min and 2, 3, 4, 6, 8, 12, 16 and 24 h postdose)
| Intervention | ng/mL*h (Mean) |
|---|
| Test | 12586.17 |
| Reference | 13739.43 |
AUC0-t of NAC After Single Dose Administration of Test and Reference
AUC0-t is the Area under the concentration-time curve from time zero to time t, calculated with the linear trapezoidal summation from time 0 to the last measurable data point. (NCT02265224)
Timeframe: 0-24h (5,15, 30, 45, 60, 75, 90 min and 2, 3, 4, 6, 8, 12, 16 and 24 h postdose)
| Intervention | ng/mL*h (Mean) |
|---|
| Test | 10637.87 |
| Reference | 11773.11 |
Cmax of NAC After Single Dose Administration of Test and Reference
Cmax is the maximum concentration level of the drug reached in plasma. (NCT02265224)
Timeframe: 0-24h (5,15, 30, 45, 60, 75, 90 min and 2, 3, 4, 6, 8, 12, 16 and 24 h postdose)
| Intervention | ng/mL (Mean) |
|---|
| Test | 2804.38 |
| Reference | 3215.63 |
Frel of NAC After Single Dose Administration of Test and Reference
Frel is the relative bioavailability, calculated as ratio AUC0-t (test)/ AUC0-t (reference) (NCT02265224)
Timeframe: 0-24h (5,15, 30, 45, 60, 75, 90 min and 2, 3, 4, 6, 8, 12, 16 and 24 h postdose)
| Intervention | percentage (Mean) |
|---|
| Enrolled Subjects Set | 92.82 |
Muscle Glutathione Concentration
Muscle glutathione concentrations measured by liquid chromatography (NCT02348775)
Timeframe: 20-weeks
| Intervention | micromol/g.Hb (Mean) |
|---|
| GlyNAC | 0.5 |
| Control Arm | 2.2 |
Mean Change in the Children's Depression Rating Scale (CDRS) Score
The Children's Depression Rating Scale (CDRS) is a clinician-rated instrument with 17 items scored on a 1 to 5 or 1 to 7 scale. A rating of 1 indicates normal, thus the minimum score is 17. The maximum score is 113. Scores of 20-30 suggest borderline depression. Scores of 40-60 indicate moderate depression. (NCT02357290)
Timeframe: Baseline and Endpoint (12 weeks or last observation carried forward if dropped prior to week 12)
| Intervention | score on a scale (Mean) |
|---|
| Open-Label Treatment With NAC | -5.2 |
Mean Change in the Young Mania Rating Scale (YMRS) Score
The Young Mania Rating Scale (YMRS) consists of 7 items rated on a scale from 0 (symptoms not present) to 4 (symptoms extremely severe) and 4 items rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe).The YMRS score ranges from 0-60. Questions are asked about the last week. A higher score signifies more severe manic symptoms. (NCT02357290)
Timeframe: Baseline and Endpoint (12 weeks or last observation carried forward if dropped prior to week 12)
| Intervention | score on a scale (Mean) |
|---|
| Open-Label Treatment With NAC | -8.1 |
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Trial Outcome Index
Participants were asked to complete the FACIT-F questionnaire through the NIH online, self-administered Clinical Trials Survey System. The Trial Outcome Index (TOI) is the sum of the physical well-being, functional well-being and 'additional concerns' subscales. The minimum value = 0, and maximum value = 52. Scores under 30 is considered to be severe fatigue. Higher scores represent a better outcome/QOL. (NCT02362425)
Timeframe: 12 months
| Intervention | scores on a scale (Least Squares Mean) |
|---|
| N-acetylcysteine (NAC) | 37.6 |
| Placebo | 37.0 |
Urine 15-F2t Isoprostane Concentration
Urine will be assayed for 15-isoprostane-F2, which is formed when arachidonic acid reacts with reactive oxygen species(ROS). A validated gas chromatography(GC)-mass spectrometer (MS) method will be used to quantify 15-isoprostane-F2 (NCT02362425)
Timeframe: 12 months
| Intervention | ng/mg Cr (Least Squares Mean) |
|---|
| N-acetylcysteine (NAC) | 2.7 |
| Placebo | 2.6 |
Urine 15-F2t Isoprostane Concentration at Baseline
Urine will be assayed for 15-isoprostane-F2, which is formed when arachidonic acid reacts with reactive oxygen species(ROS). A validated gas chromatography(GC)-mass spectrometer (MS) method will be used to quantify 15-isoprostane-F2 (NCT02362425)
Timeframe: Baseline
| Intervention | ng/mg Cr (Mean) |
|---|
| RYR1-RM Volunteers | 3.17 |
| Healthy Volunteers | 1.36 |
Urine 15-F2t Isoprostane Concentration Pre-Intervention
Urine will be assayed for 15-isoprostane-F2, which is formed when arachidonic acid reacts with reactive oxygen species(ROS). A validated gas chromatography(GC)-mass spectrometer (MS) method will be used to quantify 15-isoprostane-F2 (NCT02362425)
Timeframe: 6 months
| Intervention | ng/mg Cr (Mean) |
|---|
| N-acetylcysteine (NAC) | 3.6 |
| Placebo | 3.1 |
Walk/Run 10 Meters
Participants completed the following timed function tests: supine to stand, ascend four steps, descend four steps, and walk/run 10 meters. For walk/run 10 meters, participants were timed as they walked/ran a marked 10-meter course as quickly as possible. (NCT02362425)
Timeframe: 12 months
| Intervention | seconds (Least Squares Mean) |
|---|
| N-acetylcysteine (NAC) | 5.2 |
| Placebo | 5.9 |
Walk/Run 10 Meters Pre-Intervention
Participants completed the following timed function tests: supine to stand, ascend four steps, descend four steps, and walk/run 10 meters. For walk/run 10 meters, participants were timed as they walked/ran a marked 10-meter course as quickly as possible. (NCT02362425)
Timeframe: 6 months
| Intervention | seconds (Mean) |
|---|
| N-acetylcysteine (NAC) | 5.0 |
| Placebo | 4.6 |
Adult Quality of Life in Neurological Disorders (NeuroQoL) Fatigue
Participants were asked to complete the NeuroQoL questionnaire through the NIH online, self-administered Clinical Trials Survey System. The NeuroQoL scores were normed to 100, meaning that the raw score is converted to a scale where 50 is the mean and the standard deviation is 10. Scores less than 50 indicate less fatigue compared to the average and scores over 50 indicate more fatigue than the average. Lower scores represent better outcomes. (NCT02362425)
Timeframe: 12 months
| Intervention | t score (Least Squares Mean) |
|---|
| N-acetylcysteine (NAC) | 45.1 |
| Placebo | 51.5 |
Adult Quality of Life in Neurological Disorders (NeuroQoL) Fatigue Pre-Intervention
Participants were asked to complete the NeuroQoL questionnaire through the NIH online, self-administered Clinical Trials Survey System. The NeuroQoL scores were normed to 100, meaning that the raw score is converted to a scale where 50 is the mean and the standard deviation is 10. Scores less than 50 indicate less fatigue compared to the average and scores over 50 indicate more fatigue than the average. Lower scores represent better outcomes. (NCT02362425)
Timeframe: 6 months
| Intervention | t score (Mean) |
|---|
| N-acetylcysteine (NAC) | 53.25 |
| Placebo | 51.9 |
Blood Glutathione Reduced (GSH):Oxidized (GSSG) Ratio
GSH:GSSG ratio analyzed only at baseline to offer comparison of RYR1-RM affected individuals to the general population. (NCT02362425)
Timeframe: Baseline
| Intervention | ratio (Mean) |
|---|
| RYR1-RM Volunteers | 10.8 |
| Healthy Volunteer | 0.54 |
DCF-fluorescence Intensity (AU)
Dichlorodihydrofluorescein (DCFH) will be used on participate muscle biopsies to analyze intracellular oxidant activity [H2DCFDA (H2-DCF, DCF)]. (NCT02362425)
Timeframe: 12 months
| Intervention | AU (Mean) |
|---|
| N-acetylcysteine (NAC) | 1.9 |
| Placebo | 3.4 |
DCF-fluorescence Intensity (AU) Pre-Intervention
Dichlorodihydrofluorescein (DCFH) will be used on participate muscle biopsies to analyze intracellular oxidant activity [H2DCFDA (H2-DCF, DCF)]. (NCT02362425)
Timeframe: 6 months
| Intervention | AU (Mean) |
|---|
| N-acetylcysteine (NAC) | 1.7 |
| Placebo | 2.0 |
Descend Steps
Participants completed the following timed function tests: supine to stand, ascend four steps, descend four steps, and walk/run 10 meters. For time taken to descend four steps, the subject was asked to descend four steps whilst being timed. (NCT02362425)
Timeframe: 12 months
| Intervention | seconds (Least Squares Mean) |
|---|
| N-acetylcysteine (NAC) | 1.9 |
| Placebo | 2.4 |
Descend Steps Pre-Intervention
Participants completed the following timed function tests: supine to stand, ascend four steps, descend four steps, and walk/run 10 meters. For time taken to descend four steps, the subject was asked to descend four steps whilst being timed. (NCT02362425)
Timeframe: 6 months
| Intervention | seconds (Mean) |
|---|
| N-acetylcysteine (NAC) | 2.2 |
| Placebo | 2.3 |
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Total Score
Participants were asked to complete the FACIT-f questionnaire through the NIH online, self-administered Clinical Trials Survey System. Minimum value = 0, maximum value = 160. Higher scores represent a better outcome/ better QOL. (NCT02362425)
Timeframe: 12 months
| Intervention | scores on a scale (Least Squares Mean) |
|---|
| N-acetylcysteine (NAC) | 76.1 |
| Placebo | 73.6 |
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Total Score Pre-Intervention
Participants were asked to complete the FACIT-f questionnaire through the NIH online, self-administered Clinical Trials Survey System. Minimum value = 0, maximum value = 160. Higher scores represent a better outcome/ better QOL. (NCT02362425)
Timeframe: 6 months
| Intervention | scores on a scale (Mean) |
|---|
| N-acetylcysteine (NAC) | 69.2 |
| Placebo | 71.3 |
Peak Torque Flexion
Lower-body isometric strength testing was used to determine peak torque during flexion and extension. Participant's blood pressure was assessed, to rule-out hypertension (>140/90), prior to starting the test. Participants were then asked to push against a stationary arm and remained at the same joint angle for the duration of each test. Two short trials were completed to establish maximal force for each participant. This was followed by a long trial of flexion and extension to capture rate of fatigue to 50% after reaching their pre-determined maximal force. In the interest of safety, participants with hypertension and/or a history of knee injury did not perform the test. (NCT02362425)
Timeframe: 12 months
| Intervention | nM (Least Squares Mean) |
|---|
| N-acetylcysteine (NAC) | 24.7 |
| Placebo | 22.6 |
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Trial Outcome Index Pre-Intervention
Participants were asked to complete the FACIT-F questionnaire through the NIH online, self-administered Clinical Trials Survey System. The Trial Outcome Index (TOI) is the sum of the physical well-being, functional well-being and 'additional concerns' subscales. The minimum value = 0, and maximum value = 52. Scores under 30 is considered to be severe fatigue. Higher scores represent a better outcome/QOL. (NCT02362425)
Timeframe: 6 months
| Intervention | scores on a scale (Mean) |
|---|
| N-acetylcysteine (NAC) | 33.8 |
| Placebo | 34.3 |
Hand Grip Strength
Grip and pinch strength were determined using Myotools dynamometry. The myogrip hand held dynamometer was used to assess grip strength. Higher scores represent better outcomes. (NCT02362425)
Timeframe: 12 months
| Intervention | kg (Least Squares Mean) |
|---|
| N-acetylcysteine (NAC) | 17.8 |
| Placebo | 17.9 |
Hand Grip Strength Pre-Intervention
Grip and pinch strength were determined using Myotools dynamometry. The myogrip hand held dynamometer was used to assess grip strength. Higher scores represent better outcomes. (NCT02362425)
Timeframe: 6 months
| Intervention | kg (Mean) |
|---|
| N-acetylcysteine (NAC) | 20.5 |
| Placebo | 17.5 |
Hand Pinch Strength
Grip and pinch strength were determined using Myotools dynamometry. The myopinch pinch gauge was used to measure finger strength. Higher scores represent better outcomes. (NCT02362425)
Timeframe: 12 months
| Intervention | kg (Least Squares Mean) |
|---|
| N-acetylcysteine (NAC) | 4.7 |
| Placebo | 4.9 |
Hand Pinch Strength Pre-Intervention
Grip and pinch strength were determined using Myotools dynamometry. The myopinch pinch gauge was used to measure finger strength. Higher scores represent better outcomes. (NCT02362425)
Timeframe: 6 months
| Intervention | kg (Mean) |
|---|
| N-acetylcysteine (NAC) | 6.5 |
| Placebo | 5.1 |
Motor Function Measure-32 (MFM-32) Domain 1 (D1)
Motor Function Measure, MFM-32 is a well-established scale of motor function in congenital muscle disease. The D1 domains measure standard and transfers, and consist of 13 items. Generic Values for each domain are: 0 = cannot perform the task, 1 = initiated the task, 2 - performs the movement incompletely, or completely but imperfectly, 3 = performs the task fully and 'normally'. Total score is the sum of all the domains for D1 divided by the maximum score possible and multiplied by 100. Min=0, Max = 100. Lower numbers on the scale represent a worse outcome. (NCT02362425)
Timeframe: 12 months
| Intervention | % of maximum score (Least Squares Mean) |
|---|
| N-acetylcysteine (NAC) | 74.9 |
| Placebo | 71.5 |
Motor Function Measure-32 (MFM-32) Domain 1 (D1) Pre-Intervention
Motor Function Measure, MFM-32 is a well-established scale of motor function in congenital muscle disease. The D1 domains measure standard and transfers, and consist of 13 items. Generic Values for each domain are: 0 = cannot perform the task, 1 = initiated the task, 2 - performs the movement incompletely, or completely but imperfectly, 3 = performs the task fully and 'normally'. Total score is the sum of all the domains for D1 divided by the maximum score possible and multiplied by 100. Min=0, Max = 100. Lower numbers on the scale represent a worse outcome. (NCT02362425)
Timeframe: 6 months
| Intervention | % of maximum score (Mean) |
|---|
| N-acetylcysteine (NAC) | 75.8 |
| Placebo | 71.6 |
Motor Function Measure-32 (MFM-32) Domain 2 (D2)
Motor Function Measure, MFM-32 is a well-established scale of motor function in congenital muscle disease. The D2 domains measure axial and proximal motor function and consists of 12 items. Generic Values for each domain are: 0 = cannot perform the task, 1 = initiated the task, 2 - performs the movement incompletely, or completely but imperfectly, 3 = performs the task fully and 'normally'. The total score is the sum of all the MFM-32 domains for D2, divided by maximum score possible and multiplied by 100. Min = 0, Max = 100. Lower numbers on the scale represent a worse outcome. (NCT02362425)
Timeframe: 12 months
| Intervention | % of maximum score (Least Squares Mean) |
|---|
| N-acetylcysteine (NAC) | 97.0 |
| Placebo | 96.7 |
Motor Function Measure-32 (MFM-32) Domain 2 (D2) Pre-Intervention
Motor Function Measure, MFM-32 is a well-established scale of motor function in congenital muscle disease. The D2 domains measure axial and proximal motor function and consists of 12 items. Generic Values for each domain are: 0 = cannot perform the task, 1 = initiated the task, 2 - performs the movement incompletely, or completely but imperfectly, 3 = performs the task fully and 'normally'. The total score is the sum of all the MFM-32 domains for D2, divided by maximum score possible and multiplied by 100. Min = 0, Max = 100. Lower numbers on the scale represent a worse outcome. (NCT02362425)
Timeframe: 6 months
| Intervention | % of maximum score (Mean) |
|---|
| N-acetylcysteine (NAC) | 96.0 |
| Placebo | 96.6 |
Motor Function Measure-32 (MFM-32) Domain 3 (D3)
Motor Function Measure, MFM-32 is a well-established scale of motor function in congenital muscle disease. The D3 domains measure distal motor function and consist of 7 items. Generic Values for each domain are: 0 = cannot perform the task, 1 = initiated the task, 2 - performs the movement incompletely, or completely but imperfectly, 3 = performs the task fully and 'normally'. The total score is the sum of all the MFM-32 domains for D3, divided by maximum score possible and multiplied by 100. Min = 0, Max = 100. Lower numbers on the scale represent a worse outcome. (NCT02362425)
Timeframe: 12 months
| Intervention | % of maximum score (Least Squares Mean) |
|---|
| N-acetylcysteine (NAC) | 95.5 |
| Placebo | 96.7 |
Motor Function Measure-32 (MFM-32) Domain 3 (D3) Pre-Intervention
Motor Function Measure, MFM-32 is a well-established scale of motor function in congenital muscle disease. The D3 domains measure distal motor function and consist of 7 items. Generic Values for each domain are: 0 = cannot perform the task, 1 = initiated the task, 2 - performs the movement incompletely, or completely but imperfectly, 3 = performs the task fully and 'normally'. The total score is the sum of all the MFM-32 domains for D3, divided by maximum score possible and multiplied by 100. Min = 0, Max = 100. Lower numbers on the scale represent a worse outcome. (NCT02362425)
Timeframe: 6 months
| Intervention | % of maximum score (Mean) |
|---|
| N-acetylcysteine (NAC) | 96.7 |
| Placebo | 95.2 |
Motor Function Measure-32 (MFM-32) Total Score
Motor Function Measure, MFM-32 is a well-established scale of motor function in congenital muscle disease. Generic Values for each domain are: 0 = cannot perform the task, 1 = initiated the task, 2 - performs the movement incompletely, or completely but imperfectly, 3 = performs the task fully and 'normally'. The total score is the sum of all the MFM-32 domains, divided by maximum score possible (96) and multiplied by 100. Min = 0, Max = 100. Lower numbers on the scale represent a worse outcome. (NCT02362425)
Timeframe: 12 months
| Intervention | % of maximum score (Least Squares Mean) |
|---|
| N-acetylcysteine (NAC) | 84.1 |
| Placebo | 83.0 |
Motor Function Measure-32 (MFM-32) Total Score Pre-Intervention
Motor Function Measure, MFM-32 is a well-established scale of motor function in congenital muscle disease. Generic Values for each domain are: 0 = cannot perform the task, 1 = initiated the task, 2 - performs the movement incompletely, or completely but imperfectly, 3 = performs the task fully and 'normally'. The total score is the sum of all the MFM-32 domains, divided by maximum score possible (96) and multiplied by 100. Min = 0, Max = 100. Lower numbers on the scale represent a worse outcome. (NCT02362425)
Timeframe: 6 months
| Intervention | % of maximum score (Mean) |
|---|
| N-acetylcysteine (NAC) | 84.4 |
| Placebo | 82.7 |
Multidimensional Fatigue Inventory - 20 (MFI-20) General Fatigue Score
Participants were asked to complete the MFI-20 questionnaire through the NIH online, self-administered Clinical Trials Survey System. The MFI consists of 5 subscales: general fatigue, physical fatigue, mental fatigue, reduced activity, and reduced motivation. Values range from 4-20 for each scale. Higher scores represent increased fatigue/ worse outcome. (NCT02362425)
Timeframe: 12 months
| Intervention | scores on a scale (Least Squares Mean) |
|---|
| N-acetylcysteine (NAC) | 11.6 |
| Placebo | 13.7 |
Multidimensional Fatigue Inventory - 20 (MFI-20) General Fatigue Score Pre-Intervention
Participants were asked to complete the MFI-20 questionnaire through the NIH online, self-administered Clinical Trials Survey System. The MFI consists of 5 subscales: general fatigue, physical fatigue, mental fatigue, reduced activity, and reduced motivation. Values range from 4-20 for each scale. Higher scores represent increased fatigue/ worse outcome. (NCT02362425)
Timeframe: 6 months
| Intervention | scores on a scale (Mean) |
|---|
| N-acetylcysteine (NAC) | 12.9 |
| Placebo | 14.3 |
Multidimensional Fatigue Inventory-20 (MFI-20) Mental Fatigue Score
Participants were asked to complete the MFI-20 questionnaire through the NIH online, self-administered Clinical Trials Survey System. The MFI consists of 5 subscales: general fatigue, physical fatigue, mental fatigue, reduced activity, and reduced motivation. Values range from 4-20 for each scale. Higher scores represent increased fatigue/ worse outcome. (NCT02362425)
Timeframe: 12 months
| Intervention | scores on a scale (Least Squares Mean) |
|---|
| N-acetylcysteine (NAC) | 8.8 |
| Placebo | 8.6 |
Multidimensional Fatigue Inventory-20 (MFI-20) Mental Fatigue Score Pre-Intervention
Participants were asked to complete the MFI-20 questionnaire through the NIH online, self-administered Clinical Trials Survey System. The MFI consists of 5 subscales: general fatigue, physical fatigue, mental fatigue, reduced activity, and reduced motivation. Values range from 4-20 for each scale. Higher scores represent increased fatigue/ worse outcome. (NCT02362425)
Timeframe: 6 months
| Intervention | scores on a scale (Mean) |
|---|
| N-acetylcysteine (NAC) | 8.8 |
| Placebo | 9.7 |
Multidimensional Fatigue Inventory-20 (MFI-20) Physical Fatigue Score
Participants were asked to complete the MFI-20 questionnaire through the NIH online, self-administered Clinical Trials Survey System. The MFI consists of 5 subscales: general fatigue, physical fatigue, mental fatigue, reduced activity, and reduced motivation. Values range from 4-20 for each scale. Higher scores represent increased fatigue/ worse outcome. (NCT02362425)
Timeframe: 12 months
| Intervention | scores on a scale (Least Squares Mean) |
|---|
| N-acetylcysteine (NAC) | 11.5 |
| Placebo | 11.9 |
Multidimensional Fatigue Inventory-20 (MFI-20) Physical Fatigue Score Pre-Intervention
Participants were asked to complete the MFI-20 questionnaire through the NIH online, self-administered Clinical Trials Survey System. The MFI consists of 5 subscales: general fatigue, physical fatigue, mental fatigue, reduced activity, and reduced motivation. Values range from 4-20 for each scale. Higher scores represent increased fatigue/ worse outcome. (NCT02362425)
Timeframe: 6 months
| Intervention | scores on a scale (Mean) |
|---|
| N-acetylcysteine (NAC) | 12.1 |
| Placebo | 13.0 |
Multidimensional Fatigue Inventory-20 (MFI-20) Reduced Activity Score
Participants were asked to complete the MFI-20 questionnaire through the NIH online, self-administered Clinical Trials Survey System. The MFI consists of 5 subscales: general fatigue, physical fatigue, mental fatigue, reduced activity, and reduced motivation. Values range from 4-20 for each scale. Higher scores represent increased fatigue/ worse outcome. (NCT02362425)
Timeframe: 12 months
| Intervention | scores on a scale (Least Squares Mean) |
|---|
| N-acetylcysteine (NAC) | 9.2 |
| Placebo | 8.7 |
Multidimensional Fatigue Inventory-20 (MFI-20) Reduced Activity Score Pre-Intervention
Participants were asked to complete the MFI-20 questionnaire through the NIH online, self-administered Clinical Trials Survey System. The MFI consists of 5 subscales: general fatigue, physical fatigue, mental fatigue, reduced activity, and reduced motivation. Values range from 4-20 for each scale. Higher scores represent increased fatigue/ worse outcome. (NCT02362425)
Timeframe: 6 months
| Intervention | scores on a scale (Mean) |
|---|
| N-acetylcysteine (NAC) | 9.5 |
| Placebo | 11.3 |
Multidimensional Fatigue Inventory-20 (MFI-20) Reduced Motivation Score
Participants were asked to complete the MFI-20 questionnaire through the NIH online, self-administered Clinical Trials Survey System. The MFI consists of 5 subscales: general fatigue, physical fatigue, mental fatigue, reduced activity, and reduced motivation. Values range from 4-20 for each scale. Higher scores represent increased fatigue/ worse outcome. (NCT02362425)
Timeframe: 12 months
| Intervention | scores on a scale (Least Squares Mean) |
|---|
| N-acetylcysteine (NAC) | 7.8 |
| Placebo | 7.4 |
Multidimensional Fatigue Inventory-20 (MFI-20) Reduced Motivation Score Pre-Intervention
Participants were asked to complete the MFI-20 questionnaire through the NIH online, self-administered Clinical Trials Survey System. The MFI consists of 5 subscales: general fatigue, physical fatigue, mental fatigue, reduced activity, and reduced motivation. Values range from 4-20 for each scale. Higher scores represent increased fatigue/ worse outcome. (NCT02362425)
Timeframe: 6 months
| Intervention | scores on a scale (Mean) |
|---|
| N-acetylcysteine (NAC) | 7.9 |
| Placebo | 9.1 |
Peak Torque Extension
Lower-body isometric strength testing was used to determine peak torque during flexion and extension. Participant's blood pressure was assessed, to rule-out hypertension (>140/90), prior to starting the test. Participants were then asked to push against a stationary arm and remained at the same joint angle for the duration of each test. Two short trials were completed to establish maximal force for each participant. This was followed by a long trial of flexion and extension to capture rate of fatigue to 50% after reaching their pre-determined maximal force. In the interest of safety, participants with hypertension and/or a history of knee injury did not perform the test. (NCT02362425)
Timeframe: 12 months
| Intervention | nM (Least Squares Mean) |
|---|
| N-acetylcysteine (NAC) | 24.7 |
| Placebo | 38.8 |
Peak Torque Extension Pre-Intervention
Lower-body isometric strength testing was used to determine peak torque during flexion and extension. Participant's blood pressure was assessed, to rule-out hypertension (>140/90), prior to starting the test. Participants were then asked to push against a stationary arm and remained at the same joint angle for the duration of each test. Two short trials were completed to establish maximal force for each participant. This was followed by a long trial of flexion and extension to capture rate of fatigue to 50% after reaching their pre-determined maximal force. In the interest of safety, participants with hypertension and/or a history of knee injury did not perform the test. (NCT02362425)
Timeframe: 6 months
| Intervention | nM (Mean) |
|---|
| N-acetylcysteine (NAC) | 56.9 |
| Placebo | 41.6 |
Peak Torque Flexion Pre-Intervention
Lower-body isometric strength testing was used to determine peak torque during flexion and extension. Participant's blood pressure was assessed, to rule-out hypertension (>140/90), prior to starting the test. Participants were then asked to push against a stationary arm and remained at the same joint angle for the duration of each test. Two short trials were completed to establish maximal force for each participant. This was followed by a long trial of flexion and extension to capture rate of fatigue to 50% after reaching their pre-determined maximal force. In the interest of safety, participants with hypertension and/or a history of knee injury did not perform the test. (NCT02362425)
Timeframe: 6 months
| Intervention | nM (Mean) |
|---|
| N-acetylcysteine (NAC) | 31.9 |
| Placebo | 25.2 |
Pediatric Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Total Score
Pediatric participants (< 18 years) were asked to complete the Peds-FACIT-F questionnaire through the NIH online, self-administered Clinical Trials Survey System.Minimum value = 0, maximum value = 52. Higher scores represent a better outcome/ better QOL. (NCT02362425)
Timeframe: 12 months
| Intervention | scores on a scale (Least Squares Mean) |
|---|
| N-acetylcysteine (NAC) | 29.8 |
| Placebo | 42.3 |
Pediatric Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Total Score Pre-Intervention
Pediatric participants (< 18 years) were asked to complete the Peds-FACIT-F questionnaire through the NIH online, self-administered Clinical Trials Survey System.Minimum value = 0, maximum value = 52. Higher scores represent a better outcome/ better QOL. (NCT02362425)
Timeframe: 6 months
| Intervention | scores on a scale (Mean) |
|---|
| N-acetylcysteine (NAC) | 43.2 |
| Placebo | 37.0 |
Pediatric Quality of Life in Neurological Disorders (NeuroQoL) Fatigue
Participants were asked to complete the NeuroQoL questionnaire through the NIH online, self-administered Clinical Trials Survey System. NeuroQoL scores were normed to 100 meaning that the raw score is converted to a scale where 50 is the mean and the standard deviation is 10. Scores less than 50 indicate less fatigue compared to the average and scores over 50 indicate more fatigue than the average. Lower scores represent better outcomes. (NCT02362425)
Timeframe: 12 months
| Intervention | t score (Least Squares Mean) |
|---|
| N-acetylcysteine (NAC) | 43.1 |
| Placebo | 53.1 |
Pediatric Quality of Life in Neurological Disorders (NeuroQoL) Fatigue Pre-Intervention
Participants were asked to complete the NeuroQoL questionnaire through the NIH online, self-administered Clinical Trials Survey System. NeuroQoL scores were normed to 100 meaning that the raw score is converted to a scale where 50 is the mean and the standard deviation is 10. Scores less than 50 indicate less fatigue compared to the average and scores over 50 indicate more fatigue than the average. Lower scores represent better outcomes. (NCT02362425)
Timeframe: 6 months
| Intervention | t score (Mean) |
|---|
| N-acetylcysteine (NAC) | 45.9 |
| Placebo | 52.8 |
Six Minute Walk Test (6MWT)
Meters walked in 6 minutes will be recorded; distances in meters will be recorded at each minute interval; speed will be calculated. (NCT02362425)
Timeframe: 12 months
| Intervention | meters (Least Squares Mean) |
|---|
| N-acetylcysteine (NAC) | 495.8 |
| Placebo | 471.9 |
Six Minute Walk Test (6MWT) Pre-Intervention
Meters walked in 6 minutes will be recorded; distances in meters will be recorded at each minute interval; speed will be calculated. (NCT02362425)
Timeframe: 6 months
| Intervention | meters (Mean) |
|---|
| N-acetylcysteine (NAC) | 519.1 |
| Placebo | 453.8 |
Supine to Stand
Participants completed the following timed function tests: supine to stand, ascend four steps, descend four steps, and walk/run 10 meters. For time taken to transition from supine to standing, participants were asked to lay supine and then the time taken to move from supine to standing was recorded. (NCT02362425)
Timeframe: 12 months
| Intervention | seconds (Least Squares Mean) |
|---|
| N-acetylcysteine (NAC) | 7.4 |
| Placebo | 8.4 |
Supine to Stand Pre-Intervention
Participants completed the following timed function tests: supine to stand, ascend four steps, descend four steps, and walk/run 10 meters. For time taken to transition from supine to standing, participants were asked to lay supine and then the time taken to move from supine to standing was recorded. (NCT02362425)
Timeframe: 6 months
| Intervention | seconds (Mean) |
|---|
| N-acetylcysteine (NAC) | 6.9 |
| Placebo | 6.7 |
Time to Ascend Steps (Seconds)
Participants completed the following timed function tests: supine to stand, ascend four steps, descend four steps, and walk/run 10 meters. For time taken to ascend four steps, the subject was asked to ascend four steps whilst being timed. (NCT02362425)
Timeframe: 12 months
| Intervention | seconds (Least Squares Mean) |
|---|
| N-acetylcysteine (NAC) | 3.2 |
| Placebo | 3.3 |
Time to Ascend Steps (Seconds) Pre-Intervention
Participants completed the following timed function tests: supine to stand, ascend four steps, descend four steps, and walk/run 10 meters. For time taken to ascend four steps, the subject was asked to ascend four steps whilst being timed. (NCT02362425)
Timeframe: 6 months
| Intervention | seconds (Mean) |
|---|
| N-acetylcysteine (NAC) | 2.9 |
| Placebo | 3.4 |
Safety of Daily Dose of NAC (Number of Patients With Adverse Advents)
Number of patients with adverse advents (NCT02379637)
Timeframe: 7 Days
| Intervention | participants (Number) |
|---|
| A N-acetylcysteine | 4 |
| B Placebo | 4 |
Cough Count (Number of Coughs Will be Measured by a 24-hour Ambulatory Cough Monitoring System for the First 72 Hours)
Number of coughs will be measured by a 24-hour ambulatory cough monitoring system for the first 72 hours (NCT02379637)
Timeframe: 72 hours
| Intervention | log-transformed total cough count (Mean) |
|---|
| A N-acetylcysteine | 6.92 |
| B Placebo | 6.51 |
PTSD Symptoms
PTSD Checklist - Military (PCL-M) The PCL-M is a seventeen question self-report, scored on a scale from 1 to 5, with possible scores ranging from 17 to 85. The scores from each question are summed to get a total score (17-85). A higher total indicates a higher severity of PTSD symptoms. (NCT02499029)
Timeframe: 8 weeks
| Intervention | units on a scale (Mean) |
|---|
| Week 4 | Week 8 |
|---|
| N-Acetylcysteine | 33.8 | 31.2 |
,| Placebo | 41.9 | 41.9 |
PTSD Symptoms
Clinician Administered PTSD Scale IV (CAPS) The CAPS IV measures seventeen symptoms based on intensity and frequency. Intensity and frequency scores are summed to create a severity score for each question. Severity scores are summed to get a total score. A higher total score indicates a higher severity of PTSD symptoms.The full range for CAPS IV is 0-136. (NCT02499029)
Timeframe: 8 weeks
| Intervention | units on a scale (Mean) |
|---|
| 4 Weeks | 8 Weeks |
|---|
| N-Acetylcysteine | 38.7 | 32.0 |
,| Placebo | 52.8 | 51.5 |
Craving
Visual Analogue Scale (VAS) The VAS measures alcohol craving on a scale from 0 to 10. A higher score indicates a higher level of craving. (NCT02499029)
Timeframe: 8 weeks
| Intervention | units on a scale (Mean) |
|---|
| Amount of Craving Week 4 | Amount of Craving Week 8 | Frequency of Craving Week 4 | Frequency of Craving Week 8 | Intensity of Craving Week 4 | Intensity of Craving Week 8 |
|---|
| N-Acetylcysteine | 1.8 | .7 | 1.8 | 1.0 | 1.8 | 1.3 |
,| Placebo | 2.8 | 2.8 | 2.4 | 3.0 | 2.9 | 2.8 |
Depression
Beck Depression Inventory (BDI) The BDI measures presence and severity of depression. It has 21 questions that are rated from 0-3 with a highest possible score of 63. A higher score indicates a higher severity of depression. (NCT02499029)
Timeframe: 8 weeks
| Intervention | units on a scale (Mean) |
|---|
| Week 4 | Week 8 |
|---|
| N-Acetylcysteine | 10.9 | 9.9 |
,| Placebo | 18.5 | 19.3 |
Hangover Symptom Scale
"In the morning, each participate will fill out a Hangover Symptom Score questionnaire, evaluating each hangover symptom on a 0 - 4 point Hangover Symptom Severity scale. 0 representing strongly disagree or feels like I did not drink last night to 4 representing strongly agree or I'm so hungover / I'm never drinking again for each symptom. The symptoms on the Hangover Symptom Scale are: feeling thirsty or dehydrated, feeling more tired than usual, headache, nauseated, vomited, feeling weak, difficulty concentrating, more sensitive to light and sound than usual, sweating more than usual, had trouble sleeping, feeling anxious, feeling depressed, experienced trembling or shaking. The total score could range from 0-52 with 0 being no symptoms of hangover and 52 being the worst symptoms of hangover. This study looked specifically at the overall hangover score, nauseated, feeling weak and headache." (NCT02541422)
Timeframe: 12 hours or less
| Intervention | units on a scale (Median) |
|---|
| total Hangover symptom score | headache | nauseated | feeling weak |
|---|
| NAC Group | 10 | 1 | 0 | 1 |
,| Placebo Group | 13 | 1 | 1 | 1 |
Plasma Redox Status - Circulating Glutathione
Fluorescent detection of plasma glutathione from samples collected during day 4 of each experimental arm (placebo vs. N-acetylcysteine) (NCT02579772)
Timeframe: pre-exercise value (day 4)
| Intervention | micromolar (Mean) |
|---|
| N-acetylcysteine | 8.97 |
| Placebo | 7.05 |
Change in Skeletal Muscle Deoxygenation - Dynamics (Mean Response Time)
Mean response time (MRT) evaluated during cycling to exhaustion during day 4 of each experimental arm (placebo vs. N-acetylcysteine) (NCT02579772)
Timeframe: Day 4
| Intervention | seconds (Mean) |
|---|
| N-acetylcysteine | 19.0 |
| Placebo | 19.0 |
Change in Central Cardiovascular Function - Cardiac Output
During cycling to exhaustion during day 4 of each experimental arm (placebo vs. N-acetylcysteine) (NCT02579772)
Timeframe: end-exercise value (Day 4)
| Intervention | liters/min (Mean) |
|---|
| N-acetylcysteine | 12.5 |
| Placebo | 12.1 |
Exercise Capacity - Time to Exhaustion
Cycling time to exhaustion during day 4 of each experimental arm (placebo vs. N-acetylcysteine) (NCT02579772)
Timeframe: end-exercise value (Day 4)
| Intervention | seconds (Mean) |
|---|
| N-acetylcysteine | 336 |
| Placebo | 325 |
Change in Skeletal Muscle Vascular Function - Capillary Blood Flow Dynamics (Mean Response Time)
Mean response time (MRT) evaluated during cycling to exhaustion during day 4 of each experimental arm (placebo vs. N-acetylcysteine) (NCT02579772)
Timeframe: Day 4
| Intervention | seconds (Mean) |
|---|
| N-acetylcysteine | 65.4 |
| Placebo | 66.5 |
Change in Pulmonary Ventilation - Minute Ventilation (VE)
During cycling to exhaustion during day 4 of each experimental arm (placebo vs. N-acetylcysteine) (NCT02579772)
Timeframe: end-exercise value (Day 4)
| Intervention | liters/min (Mean) |
|---|
| N-acetylcysteine | 78.7 |
| Placebo | 75.8 |
Change in Pulmonary Oxygen Uptake - Dynamics (Mean Response Time)
Mean response time (MRT) evaluated during cycling to exhaustion during day 4 of each experimental arm (placebo vs. N-acetylcysteine) (NCT02579772)
Timeframe: Day 4
| Intervention | seconds (Mean) |
|---|
| N-acetylcysteine | 63.0 |
| Placebo | 62.2 |
Percentage of Participants With Dose Reductions
Percentage of participants with dose reductions in N-Acetylcysteine and placebo cohorts during the 24-week treatment period. (NCT02707640)
Timeframe: From baseline up to 24 weeks
| Intervention | percentage of participants (Number) |
|---|
| N-Acetylcysteine (NAC) | 5 |
| Placebo | 4.8 |
Percentage of Participants With Early Treatment Discontinuations
Percentage of participants with early treatment discontinuations in N-Acetylcysteine and placebo cohorts during the 24-week treatment period. (NCT02707640)
Timeframe: From baseline up to 24 weeks
| Intervention | percentage of participants (Number) |
|---|
| N-Acetylcysteine (NAC) | 14.8 |
| Placebo | 11.3 |
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) is defined as any untoward medical occurrence in a participant who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. (NCT02707640)
Timeframe: Until 28 days from last dose of study treatment (Week 28)
| Intervention | percentage of participants (Number) |
|---|
| N-Acetylcysteine (NAC) | 76.7 |
| Placebo | 80.6 |
Percentage of Participants With Treatment-Emergent Adverse Events Resulting in Permanent Discontinuation of Study Treatment
(NCT02707640)
Timeframe: Until 28 days from last dose of study treatment (Week 28)
| Intervention | percentage of participants (Number) |
|---|
| N-Acetylcysteine (NAC) | 6.7 |
| Placebo | 1.6 |
Percentage of Participants With Treatment-Emergent Deaths of All Causes
(NCT02707640)
Timeframe: Until 28 days from last dose of study treatment (Week 28)
| Intervention | percentage of participants (Number) |
|---|
| N-Acetylcysteine (NAC) | 1.7 |
| Placebo | 4.8 |
Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs)
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, is life threatening, requires hospitalization or prolongation of hospitalization, or results in disability/incapacity, or congenital anomaly/birth defect. (NCT02707640)
Timeframe: Until 28 days from last dose of study treatment (Week 28)
| Intervention | percentage of participants (Number) |
|---|
| N-Acetylcysteine (NAC) | 5.0 |
| Placebo | 6.5 |
Percentage of Participants With Treatment-Emergent Adverse Events That Led to Dose Reduction or Temporary Discontinuation of Study Treatment
(NCT02707640)
Timeframe: Until 28 days from last dose of study treatment (Week 28)
| Intervention | percentage of participants (Number) |
|---|
| N-Acetylcysteine (NAC) | 10 |
| Placebo | 6.5 |
Number of Cigarettes Smoked Per Day
Measure the effects of Varenicline and N-Acetylcysteine on smoking behavior over the course of the study (NCT02723162)
Timeframe: 28 Days
| Intervention | Cigarettes per day (Mean) |
|---|
| VRN+ NAC | 5.3 |
| NAC+ PBO | 4.0 |
| VRN+ PBO | 5.3 |
| PBO+PBO | 5.0 |
rZ Change Score in Resting State Functional Connectivity From Baseline
Measure the effects of Varenicline and N-Acetylcysteine on resting-state functional connectivity while participants undergo fMRI. Fisher transformed correlation (rZ) scores will be recorded between medial prefrontal cortex and ventral striatum during a resting state scan. The higher the rZ score, the better the outcome, meaning stronger functional connectivity. rZ scores range from -1 to 1. The rZ-score central value is analogous to a central value to of a Z-score of 0, representing the population mean. (NCT02723162)
Timeframe: Baseline to day 10
| Intervention | Fisher Z (Median) |
|---|
| VRN+ NAC | .297 |
| NAC+ PBO | .060 |
| VRN+ PBO | .181 |
| PBO+PBO | .191 |
Percent Change in Blood Oxygen Level Dependent (BOLD) Signal Response
Measure the Effects of Varenicline and N-Acetylcysteine (NAC) on brain activation to smoking images while participants undergo Functional Magnetic Resonance (fMRI) Imaging. Mean percent signal change of fMRI BOLD in the insula and nucleus accumbens will be recorded during smoking images. The lower the BOLD signal response, the better the outcome, meaning reduced reactivity to smoking images. (NCT02723162)
Timeframe: 10 Days
| Intervention | Percentage change (Median) |
|---|
| Insula | Nucleus Accumbens |
|---|
| NAC+ PBO | 1.07 | 0.91 |
,| PBO+PBO | 1.19 | 1.43 |
,| VRN+ NAC | -0.09 | 0.11 |
,| VRN+ PBO | 0.08 | 0.12 |
Number of Participants With Biochemically-verified Abstinence From Smoking on Days 1-3 of the Protocol.
Abstinence will be measured through biochemical verification via breath carbon monoxide. Abstinence is defined as a 75% reduction in carbon monoxide values (parts per million) from smoking baseline levels. (NCT02737358)
Timeframe: Days 1-3 of the study protocol
| Intervention | Participants (Count of Participants) |
|---|
| Placebo | 8 |
| N-Acetylcysteine (NAC) | 6 |
Days to Relapse to Smoking Among Abstinent Participants
Relapse to smoking will be measured through carbon monoxide-verified relapse at weekly study visits among those who abstained during the 3-day quit attempt. Relapse (return to smoking) will be defined as carbon monoxide values (in parts per million) that do not meet abstinence criteria (i.e., 75% reduction from baseline smoking levels). (NCT02737358)
Timeframe: Days 4-56 of the study protocol
| Intervention | days (Mean) |
|---|
| Placebo | 17.0 |
| N-Acetylcysteine (NAC) | 3.8 |
Number of Participants With 7-day Point Prevalence Abstinence at the 8-week End-of-treatment Visit
Seven day point prevalence abstinence will be measured through biochemical verification via breath carbon monoxide and urinary cotinine analysis. Abstinence is defined as a 75% reduction in carbon monoxide values (parts per million) from smoking baseline levels and a negative urine cotinine measure (<80 ng/mL). (NCT02737358)
Timeframe: Days 49-56
| Intervention | Participants (Count of Participants) |
|---|
| Placebo | 6 |
| N-Acetylcysteine (NAC) | 4 |
Change in TBI Symptoms as Assessed by the Neurobehavioral Symptom Inventory (NSI)
Participants indicate the extent to which each of the 22 symptoms has disturbed them in the previous 2 weeks on a 5-item scale (0-none to 4-severe). The NSI total score is the sum of severity ratings of the symptoms. The scores are summed to yield a total score ranging from 0 to 88, where the higher the point value, the greater (more severe) the symptoms (NCT02791945)
Timeframe: Baseline to Week 8
| Intervention | scores on a scale (Mean) |
|---|
| N-acetylcysteine | 11.44 |
| Placebo | 10 |
Change in Percent of Heavy Drinking Days Per Week as Assessed by the Timeline Followback (TFLB)
The TLFB interview, using a calendar, asks participants to report the prior week's frequency of alcohol use on each day of the week. (NCT02791945)
Timeframe: Baseline to Week 8
| Intervention | change in percent heavy drinking days/wk (Mean) |
|---|
| N-acetylcysteine | 26.2 |
| Placebo | 26.5 |
Change in Number of Standard Drinks Per Week as Assessed by the Timeline Followback (TLFB)
The TLFB interview, using a calendar, asks participants to report the prior week's frequency of alcohol use on each day of the week. (NCT02791945)
Timeframe: Baseline to Week 8
| Intervention | Standard drinks per week (Mean) |
|---|
| N-acetylcysteine | 24.75 |
| Placebo | 18.45 |
Change in Level of Blood Markers From Baseline
Baseline to week 4 change in blood GSH/GSSG ratio (wherein GSH is glutathione in reduced state and GSSG is glutathione in oxidized state) and grey matter GSH concentration on 7T MR spectroscopy (MRS) between groups. We hypothesize that fatigue is associated with the GSH/GSSG ratio. (NCT02804594)
Timeframe: 4 weeks
| Intervention | mean absolute change in GSH/GSSG ratio (Mean) |
|---|
| N-acetyl Cysteine | -0.1 |
| Placebo | -0.6 |
Change in Fatigue Score on Questionnaires From Baseline
Change in fatigue score on questionnaires from baseline visit to week-4 is calculated for the Modified Fatigue Impact Scale (MFIS) questionnaire. The MFIS is a self-report measure to rate fatigue in Multiple Sclerosis. The total score, ranging from 0 to 84 is the sum of three subscales (physical, cognitive, and psychosocial functioning). Higher numbers indicate greater fatigue. Modified fatigue Impact scale of more than 38 is one of the inclusion criteria for the study. Study participants who scored higher value on the questionnaire at week-4 are considered to have worsened fatigue from the baseline visit. (NCT02804594)
Timeframe: 4 weeks
| Intervention | scores on a scale (Mean) |
|---|
| N-acetyl Cysteine | -11.4 |
| Placebo | -18 |
Change in Post Traumatic Stress Disorder Severity
"Post traumatic stress disorder symptoms as measured by change/reduction in score of post traumatic stress disorder checklist (PCL-5) from baseline to week 8.~Greater reduction in score indicates better treatment outcomes. (minimum score of 0 = absent to a maximum score of 80 = extreme)" (NCT02911285)
Timeframe: From baseline to week 8
| Intervention | score on a scale (Mean) |
|---|
| N-acetylcysteine (NAC) and Cognitive Behavioral Therapy (CBT) | -12.97 |
| Placebo and Cognitive Behavioral Therapy (CBT) | -9.97 |
Change in Post Traumatic Stress Disorder Severity
"Change in post traumatic stress disorder severity as measured by Change in Clinician Administered PTSD Scale (CAPS-5) score from baseline to week 8.~Greater change/reduction in score indicates better outcomes and greater reduction in PTSD symptomatology.~(minimum score of 0 = absent to a maximum score of 80 = extreme)" (NCT02911285)
Timeframe: From baseline to week 8
| Intervention | score on a scale (Mean) |
|---|
| N-acetylcysteine (NAC) and Cognitive Behavioral Therapy (CBT) | -6.93 |
| Placebo and Cognitive Behavioral Therapy (CBT) | -5.53 |
Change in Alcohol Use Disorder Severity
"Change in Alcohol Use Disorder Severity as measured by change in average drinking days per week from baseline to week 8.~Greater reduction in drinking days indicates better treatment outcomes. Drinking days measured over 1 week periods (7 days). Scale ranges from 0 days to 7 days." (NCT02911285)
Timeframe: From baseline to week 8 of treatment
| Intervention | drinking days reduction (Mean) |
|---|
| N-acetylcysteine (NAC) and Cognitive Behavioral Therapy (CBT) | -2.65 |
| Placebo and Cognitive Behavioral Therapy (CBT) | -2.82 |
Change in Alcohol Craving
"Change in Alcohol craving as measured by change in Obsessive Compulsive Drinking Scale (OCDS) Total Score.~Greater change/reduction in score indicates better outcomes and reduced alcohol craving.~(Scores range from 0 to 56)" (NCT02911285)
Timeframe: From baseline to week 8
| Intervention | score on a scale (Mean) |
|---|
| N-acetylcysteine (NAC) and Cognitive Behavioral Therapy (CBT) | -3.97 |
| Placebo and Cognitive Behavioral Therapy (CBT) | -2.92 |
Change in Alcohol Craving - Compulsive Subscale
"Change in Alcohol Craving as measured by the Obsessive Compulsive Drinking Scale (OCDS) to measure the compulsive subscale of alcohol craving.~The OCDS is a 14-item questionnaire that measures alcohol use and attempts to control drinking. Compulsive subscale includes items 7-14.~Each item is scored on a scale from 0 to 4. Scores range from 0 to 32, with lower scores representing better outcomes." (NCT02966873)
Timeframe: From baseline to week 12
| Intervention | units on a scale (Mean) |
|---|
| N-Acetylcysteine (NAC) Treatment Group | -4.584 |
| Placebo Group | -4.905 |
Change in Alcohol Craving - Obsessive Subscale
"Change in Alcohol Craving as measured by the Obsessive Compulsive Drinking Scale (OCDS) to measure the obsessive subscale of alcohol craving.~The OCDS is a 14-item questionnaire that measures alcohol use and attempts to control drinking. Obsessive subscale includes items 1-6.~Each item is scored on a scale from 0 to 4. Scores range from 0 to 28, with lower scores representing better outcomes." (NCT02966873)
Timeframe: From baseline to week 12
| Intervention | units on a scale (Mean) |
|---|
| N-Acetylcysteine (NAC) Treatment Group | -2.597 |
| Placebo Group | -2.521 |
Change in Alcohol Use Severity
"Change in Alcohol Use Severity as measured by standard drinks per day using the Time Line Follow Back (TLFB) to measure alcohol consumption.~Fewer standard drinks per day represent better outcomes. Greater change in standard drinks per day represents better outcomes." (NCT02966873)
Timeframe: From baseline to week 12
| Intervention | standard drinks per day (Mean) |
|---|
| N-Acetylcysteine (NAC) Treatment Group | -3.406 |
| Placebo Group | -3.934 |
Change in Alcohol Use Severity - Percent Days Abstinent
"Change in Alcohol Use Severity as measured by the percent days abstinent using the Time Line Follow Back (TLFB) to measure alcohol consumption.~Greater percentage of days of abstinence represents better outcomes. Greater change in Percent Days Abstinent represents better outcomes." (NCT02966873)
Timeframe: From baseline to week 12
| Intervention | percentage of days abstinent for alcohol (Mean) |
|---|
| N-Acetylcysteine (NAC) Treatment Group | 35.6 |
| Placebo Group | 31.7 |
Change in Post Traumatic Stress Disorder Symptom Severity - Self Report
"Change in Post Traumatic Stress Disorder (PTSD) symptom severity as measured by the Posttraumatic Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition [DSM-5](PCL-5) for self-reported symptoms.~The PCL-5 is a 20-item self-report measure that assesses the 20 symptoms of PTSD. The rating scale is 0-4 for each symptom/item, and overall scores range from 0-80, with lower scores representing better outcomes (less severe PTSD)." (NCT02966873)
Timeframe: From baseline to week 12
| Intervention | units on a scale (Mean) |
|---|
| N-Acetylcysteine (NAC) Treatment Group | -15.997 |
| Placebo Group | -18.129 |
Change in Post Traumatic Stress Disorder Symptom Severity - Clinician Rated
"Change in Post Traumatic Stress Disorder symptom severity as measured by Clinician Administered PTSD Scale (CAPS-5) for clinician-rated posttraumatic stress symptoms.~The CAPS-5 is a 30-item structured interview. CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 PTSD symptoms, each with severity scores ranging from 0-4. The overall total severity score for CAPS-5 ranges from 0-80, with lower scores representing better outcomes (less severe PTSD)." (NCT02966873)
Timeframe: From baseline to week 12
| Intervention | units on a scale (Mean) |
|---|
| N-Acetylcysteine (NAC) Treatment Group | -11.838 |
| Placebo Group | -13.863 |
Successful Collection of Outcome Measures
Goal: at least 80% collection of essential outcome data to demonstrate the feasibility of data collection procedures. (NCT03008889)
Timeframe: 12 months (throughout the duration of the study)
| Intervention | Participants (Count of Participants) |
|---|
| Participants Taking NAC | 1 |
| Participants Taking Placebo | 1 |
Study Medication Compliance
Goal: at least 70% treatment compliance (tablet counts and drug dairies). (NCT03008889)
Timeframe: 12 months (throughout the duration of the study)
| Intervention | Participants (Count of Participants) |
|---|
| Participants Taking NAC | 1 |
| Participants Taking Placebo | 1 |
Number of Self-Injurious Behavior Events
Direct observation of the frequency of SIB was collected at baseline in a separate observational session after completing the functional analysis and again at Week 9. Investigators set a benchmark of an average decline in the frequency of SIB of 50% within the NAC group. (NCT03008889)
Timeframe: Baseline, Week 9
| Intervention | Self injurious events (Number) |
|---|
| Baseline | 9-Weeks |
|---|
| Participants Taking NAC | 219 | 59 |
,| Participants Taking Placebo | 93 | 655 |
Percentage of Participants Randomized
Goal: randomize 1.75 participants per month (NCT03008889)
Timeframe: 12 months (throughout the duration of the study)
| Intervention | percentage of participants randomized (Number) |
|---|
| Participants Taking NAC | 100 |
| Participants Taking Placebo | 100 |
Parent Satisfaction Rating
Goal: at least 80% of parents will agree or strongly agree when asked in an anonymous survey that they would recommend the study and the study treatment to other parents of children with ASD and SIB. (NCT03008889)
Timeframe: Week 9 (at the end of the study intervention)
| Intervention | Participants (Count of Participants) |
|---|
| Participants Taking NAC | 1 |
| Participants Taking Placebo | 1 |
Change in Clinical Global Impression (CGI-I) Scale at 9 Weeks Post-intervention
The Clinical Global Impression (CGI-I) scale is a 7-item scale from 1 (Very Much Improved) through 4 (No Change) to 7 (Very Much Worse). By convention, scores of 2 (Much Improved) or 1 (Very Much Improved) are used to define positive response. (NCT03008889)
Timeframe: Week 9
| Intervention | score on a scale (Number) |
|---|
| Participants Taking NAC | 2 |
| Participants Taking Placebo | 4 |
Attrition Rate
Attrition rate is defined as the percent of subjects who did not complete the study. Goal:less than 15% (to indicate that study was acceptable to participants and parents). (NCT03008889)
Timeframe: 12 months (throughout the duration of the study)
| Intervention | percentage of participants (Number) |
|---|
| Participants Taking NAC | 0 |
| Participants Taking Placebo | 0 |
Aberrant Behavior Checklist Irritability Subscale Score at Baseline and 9 Weeks Post-intervention
The Aberrant Behavior Checklist (ABC) is a commonly used 58-item parent-rated measure of overall behavioral problems. The Irritability subscale is comprised of 15 items reflecting tantrums, aggression and self injury. Range is 0 to 45, higher scores indicate higher severity. As a preliminary efficacy outcome, it was calculated the average score at baseline and Week 9 post-intervention. (NCT03008889)
Timeframe: Baseline, Week 9
| Intervention | score on a scale (Number) |
|---|
| Score at Baseline | Score at 9-Weeks |
|---|
| Participants Taking NAC | 31 | 23 |
,| Participants Taking Placebo | 28 | 29 |
Positive Predictive Value of Screening Method of Classifying Self-injurious Behavior (SIB) by Type.
"Goal: at least 75% positive predictive value of our screening method to classify children with automatically maintained self-injurious behavior using a semi-structured interview at screening compared to the findings of five- to six-hour functional analysis at baseline. Only children who appear to have automatically maintained SIB will be referred for the baseline evaluation.~Demonstrating a high positive predictive value for the screening method is a necessary prerequisite for launching a larger study. Using the formula: Positive Predictive Value (PPV) = screen positive and true cases ÷ all positive screens, a value of 75% or greater would indicate success of the screening method used." (NCT03008889)
Timeframe: 12 months (duration of the study)
| Intervention | Participants (Count of Participants) |
|---|
| Consented Participants Before Randomization | 3 |
Mean Percent Change in Cys-DA/DOPAC Between Pre and Post-treatment Lumbar Puncture With and Without N-acetylcysteine (NAC)
Patients with Parkinson's Disease (PD) who took N-acetylcysteine (NAC), and healthy volunteers who did not take NAC, each had two separate lumbar punctures (LPs) to obtain spinal fluid. The spinal fluid samples were used to measure the ratio of the brain chemical called 5-S-cysteinyl-dopamine (Cys-DA) to the brain chemical called 3,4-Dihydroxyphenylacetic acid (Cys-DOPAC). Dopamine has 2 metabolic fates. One is the breakdown of dopamine by an enzyme to form DOPAC. The other is spontaneous oxidation to form Cys-DA. The ratio of Cys-DA/DOPAC may reflect these relative fates. If NAC reduced spontaneous oxidation to Cys-DA, then the ratio Cys-DA/DOPAC would decrease between LP 1 and LP 2, which would be reflected as a percent decrease. (NCT03104725)
Timeframe: All participants underwent a baseline LP. For PD participants, the second LP occurred approximately 2 hours after the participant had taken NAC the last NAC dose. For HV participants the second LP takes place approximately 48 hours after the first LP.
| Intervention | percent change (Mean) |
|---|
| Healthy Volunteers (HVs) | 50.1 |
| Parkinson's Disease (PD) Patients | 27.2 |
The Mean Percent Change in Cerebrospinal Fluid (CSF) Concentration of 5-S-cysteinyl-dopamine (Cys-DA) Pre and Post-N-acetylcysteine (NAC) Treatment
Patients with Parkinson's Disease (PD) who took N-acetylcysteine (NAC), and healthy volunteers who did not take NAC, each had two separate lumbar punctures (LP 1 and LP 2) to obtain spinal fluid. The spinal fluid samples were used to measure the amount of a brain chemical called 5-S-cysteinyl-dopamine (Cys-DA). The primary outcome measure is the mean change in CSF Cys-DA levels between pre and post-NAC treatment, which is calculated as the difference of CSF Cys-DA levels at pre-treatment (LP 1) and post-treatment (LP 2) divided by CSF Cys-DA at pre-treatment (LP 1). A greater percent decrease in Cys-DA levels in the brain would suggest that NAC may contribute to a reduction in the oxidation of brain dopamine, while a smaller percent decrease would suggest that NAC had no effect on the oxidation of brain dopamine. (NCT03104725)
Timeframe: All participants underwent a baseline LP. For PD participants, the second LP occurred approximately 2 hours after the participant had taken NAC the last NAC dose. For HV participants the second LP takes place approximately 48 hours after the first LP.
| Intervention | percent change (Mean) |
|---|
| Healthy Volunteers (HVs) | 45.7 |
| Parkinson's Disease (PD) Patients | 20.1 |
Mean Ratio of Cys-DA/DOPAC Pre and Post-treatment Lumbar Puncture With and Without N-acetylcysteine (NAC)
Patients with Parkinson's Disease (PD) who took N-acetylcysteine (NAC), and healthy volunteers who did not take NAC, each had two separate lumbar punctures (LPs) to obtain spinal fluid. The spinal fluid samples were used to measure the ratio of the brain chemical called 5-S-cysteinyl-dopamine (Cys-DA) to the brain chemical called 3,4-Dihydroxyphenylacetic acid (Cys-DOPAC). Dopamine has 2 possible metabolic fates or processes of degradation. One fate is the breakdown of Dopamine by an enzyme to form DOPAC. The other fate is spontaneous oxidation to form Cys-DA. The ratio of Cys-DA to DOPAC may reflect these relative fates. If NAC reduced spontaneous oxidation to Cys-DA, then the ratio Cys-DA/DOPAC ratio would decrease between LP 1 and LP 2. (NCT03104725)
Timeframe: All participants underwent a baseline LP. For PD participants, the second LP occurred approximately 2 hours after the participant had taken NAC the last NAC dose. For HV participants the second LP takes place approximately 48 hours after the first LP.
| Intervention | ratio (Mean) |
|---|
| Cys-DA/DOPAC LP1 | Cys-DA/DOPAC LP2 |
|---|
| Healthy Volunteers (HVs) | 0.12 | 0.05 |
,| Parkinson's Disease (PD) Patients | 0.16 | 0.13 |
K18(U/L)
In paracetamol overdose, the full-length variant of Keratin-18 (K-18) is released by necrotic hepatocyte death. (NCT03177395)
Timeframe: 10 hours
| Intervention | U/L (Geometric Mean) |
|---|
| Acetylcysteine (N-acetylcysteine; NAC) | 182 |
| Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC | 152 |
| Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC | 170 |
| Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC | 111 |
miR-122 (Copies/mcL)
MiR-122 is a biomarker specific for liver injury and fully conserved (translational) across in vitro models, in vivo models and humans. MiR-122 is an early marker for acute liver injury which predicts a rise in ALT activity following paracetamol overdose (NCT03177395)
Timeframe: 20 hours
| Intervention | copies/mcL (Geometric Mean) |
|---|
| Acetylcysteine (N-acetylcysteine; NAC) | 216,256 |
| Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC | 57,664 |
| Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC | 202,271 |
| Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC | 40,745 |
miR-122 (Copies/mcL)
MiR-122 is a biomarker specific for liver injury and fully conserved (translational) across in vitro models, in vivo models and humans. MiR-122 is an early marker for acute liver injury which predicts a rise in ALT activity following paracetamol overdose (NCT03177395)
Timeframe: Baseline (2 h)
| Intervention | copies/mcL (Geometric Mean) |
|---|
| Acetylcysteine (N-acetylcysteine; NAC) | 146,363 |
| Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC | 116,749 |
| Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC | 194,075 |
| Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC | 36,051 |
miR-122 (Copies/mcL)
MiR-122 is a biomarker specific for liver injury and fully conserved (translational) across in vitro models, in vivo models and humans. MiR-122 is an early marker for acute liver injury which predicts a rise in ALT activity following paracetamol overdose (NCT03177395)
Timeframe: Ratio - value at 20 hours divided by baseline value for each patient
| Intervention | copies/mcL (Geometric Mean) |
|---|
| Acetylcysteine (N-acetylcysteine; NAC) | 1.48 |
| Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC | 0.49 |
| Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC | 1.04 |
| Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC | 1.13 |
miR-122 (Delta Count)
MiR-122 is a biomarker specific for liver injury and fully conserved (translational) across in vitro models, in vivo models and humans. MiR-122 is an early marker for acute liver injury which predicts a rise in ALT activity following paracetamol overdose (NCT03177395)
Timeframe: 10 hours
| Intervention | DCt (Mean) |
|---|
| Acetylcysteine (N-acetylcysteine; NAC) | 5.41 |
| Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC | 6.14 |
| Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC | 5.01 |
| Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC | 9.00 |
miR-122 (Delta Count)
MiR-122 is a biomarker specific for liver injury and fully conserved (translational) across in vitro models, in vivo models and humans. MiR-122 is an early marker for acute liver injury which predicts a rise in ALT activity following paracetamol overdose (NCT03177395)
Timeframe: 20 hours
| Intervention | DCt (Mean) |
|---|
| Acetylcysteine (N-acetylcysteine; NAC) | 4.85 |
| Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC | 7.12 |
| Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC | 4.49 |
| Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC | 8.44 |
miR-122 (Delta Count)
MiR-122 is a biomarker specific for liver injury and fully conserved (translational) across in vitro models, in vivo models and humans. MiR-122 is an early marker for acute liver injury which predicts a rise in ALT activity following paracetamol overdose (NCT03177395)
Timeframe: Baseline (2 hours)
| Intervention | DCt (Mean) |
|---|
| Acetylcysteine (N-acetylcysteine; NAC) | 5.58 |
| Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC | 5.85 |
| Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC | 4.43 |
| Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC | 8.73 |
Additional NAC Infusion
participants required additional NAC infusions after the 12-hour NAC regimen (NCT03177395)
Timeframe: Additional NAC at 12 hour
| Intervention | Participants (Count of Participants) |
|---|
| None | One | Two |
|---|
| Acetylcysteine (N-acetylcysteine; NAC) | 3 | 1 | 2 |
,| Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC | 5 | 1 | 0 |
,| Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC | 6 | 0 | 0 |
,| Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC | 6 | 0 | 0 |
Safety Events
Adverse Events and Serious Adverse Events (NCT03177395)
Timeframe: 90 days
| Intervention | participants (Number) |
|---|
| Any Adverse event | Any serious adverse event | Adverse event after commencement of NAC treatment | Serious AE after commencement of NAC treatment | Adverse event where outcome was death | Adverse event unrelated to NAC | Adverse event possibly related to NAC | Adverse event probably related to NAC | Adverse event definitely related to NAC | Adverse event unrelated to PP100-01 | Adverse event possibly related to PP100-01 | Adverse event probably related to PP100-01 | Adverse event definitely related to PP100-01 | Any suspected unexpected serious adverse reaction | SUSAR to NAC | SUSAR to PP100-01 | SUSAR to NAC and PP100-01 |
|---|
| Acetylcysteine (N-acetylcysteine; NAC) | 6 | 2 | 6 | 1 | 0 | 3 | 2 | 3 | 2 | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC | 6 | 4 | 5 | 1 | 0 | 5 | 2 | 2 | 3 | 6 | 4 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC | 6 | 2 | 6 | 1 | 1 | 3 | 2 | 3 | 1 | 5 | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC | 6 | 3 | 6 | 2 | 0 | 5 | 2 | 2 | 1 | 6 | 2 | 0 | 0 | 1 | 0 | 1 | 0 |
miR-122(Copies/mcL)
MiR-122 is a biomarker specific for liver injury and fully conserved (translational) across in vitro models, in vivo models and humans. MiR-122 is an early marker for acute liver injury which predicts a rise in ALT activity following paracetamol overdose (NCT03177395)
Timeframe: 10 hours
| Intervention | copies/mcL (Geometric Mean) |
|---|
| Acetylcysteine (N-acetylcysteine; NAC) | 206,205 |
| Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC | 109,882 |
| Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC | 196,732 |
| Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC | 37,066 |
ALT(U/L)
The alanine aminotransferase (ALT) test is a blood test that checks for liver damage. (NCT03177395)
Timeframe: 10 hours
| Intervention | U/L (Geometric Mean) |
|---|
| Acetylcysteine (N-acetylcysteine; NAC) | 41.4 |
| Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC | 22.9 |
| Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC | 25.3 |
| Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC | 15.0 |
ALT(U/L)
The alanine aminotransferase (ALT) test is a blood test that checks for liver damage. (NCT03177395)
Timeframe: 20 hours
| Intervention | U/L (Geometric Mean) |
|---|
| Acetylcysteine (N-acetylcysteine; NAC) | 43.3 |
| Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC | 20.4 |
| Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC | 25.4 |
| Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC | 16.4 |
ALT(U/L)
The alanine aminotransferase (ALT) test is a blood test that checks for liver damage. (NCT03177395)
Timeframe: Baseline
| Intervention | U/L (Geometric Mean) |
|---|
| Acetylcysteine (N-acetylcysteine; NAC) | 42.5 |
| Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC | 24.6 |
| Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC | 29.4 |
| Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC | 17.7 |
ccK18 (U/L)
Caspace-cleaved Keratin-18 (NCT03177395)
Timeframe: Ratio - value at 20 hours divided by baseline value for each patient
| Intervention | U/L (Geometric Mean) |
|---|
| Acetylcysteine (N-acetylcysteine; NAC) | 2.22 |
| Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC | 1.49 |
| Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC | 1.02 |
| Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC | 1.08 |
ccK18 (U/L)
The shorter, Caspase cleaved form of K-18 is released following hepatocyte apoptosis (programmed cell death). (NCT03177395)
Timeframe: 10 hours
| Intervention | U/L (Geometric Mean) |
|---|
| Acetylcysteine (N-acetylcysteine; NAC) | 72 |
| Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC | 53 |
| Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC | 56 |
| Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC | 78 |
ccK18 (U/L)
The shorter, Caspase cleaved form of K-18 is released following hepatocyte apoptosis (programmed cell death). (NCT03177395)
Timeframe: 20 hours
| Intervention | U/L (Geometric Mean) |
|---|
| Acetylcysteine (N-acetylcysteine; NAC) | 149 |
| Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC | 66 |
| Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC | 85 |
| Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC | 111 |
ccK18 (U/L)
The shorter, Caspase cleaved form of K-18 is released following hepatocyte apoptosis (programmed cell death). (NCT03177395)
Timeframe: Baseline (2 hours)
| Intervention | U/L (Geometric Mean) |
|---|
| Acetylcysteine (N-acetylcysteine; NAC) | 67 |
| Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC | 45 |
| Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC | 84 |
| Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC | 104 |
INR
international normalised ratio (INR) characterise acute liver injury (ALI) and failure (ALF) (NCT03177395)
Timeframe: 10 hours
| Intervention | ratio (Mean) |
|---|
| Acetylcysteine (N-acetylcysteine; NAC) | 1.30 |
| Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC | 1.17 |
| Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC | 1.20 |
| Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC | 1.22 |
INR
international normalised ratio (INR) characterise acute liver injury (ALI) and failure (ALF) (NCT03177395)
Timeframe: 20 hours
| Intervention | ratio (Mean) |
|---|
| Acetylcysteine (N-acetylcysteine; NAC) | 1.18 |
| Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC | 1.07 |
| Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC | 1.08 |
| Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC | 1.22 |
INR
international normalised ratio (INR) characterise acute liver injury (ALI) and failure (ALF) (NCT03177395)
Timeframe: Baseline
| Intervention | ratio (Mean) |
|---|
| Acetylcysteine (N-acetylcysteine; NAC) | 1.02 |
| Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC | 1.00 |
| Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC | 0.98 |
| Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC | 1.05 |
INR
international normalised ratio (INR) characterise acute liver injury (ALI) and failure (ALF) (NCT03177395)
Timeframe: value at 20 hours divided by baseline value for each patient
| Intervention | ratio (Geometric Mean) |
|---|
| Acetylcysteine (N-acetylcysteine; NAC) | 1.15 |
| Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC | 1.07 |
| Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC | 1.10 |
| Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC | 1.10 |
K18 (U/L)
In paracetamol overdose, the full-length variant of Keratin-18 (K-18) is released by necrotic hepatocyte death. (NCT03177395)
Timeframe: 20 hours
| Intervention | U/L (Geometric Mean) |
|---|
| Acetylcysteine (N-acetylcysteine; NAC) | 347 |
| Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC | 229 |
| Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC | 172 |
| Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC | 181 |
K18 (U/L)
In paracetamol overdose, the full-length variant of Keratin-18 (K-18) is released by necrotic hepatocyte death. (NCT03177395)
Timeframe: Baseline (2 hours)
| Intervention | U/L (Geometric Mean) |
|---|
| Acetylcysteine (N-acetylcysteine; NAC) | 187 |
| Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC | 177 |
| Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC | 193 |
| Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC | 128 |
K18 (U/L)
In paracetamol overdose, the full-length variant of Keratin-18 (K-18) is released by necrotic hepatocyte death. (NCT03177395)
Timeframe: Ratio - value at 20 hours divided by baseline value for each patient
| Intervention | U/L (Geometric Mean) |
|---|
| Acetylcysteine (N-acetylcysteine; NAC) | 1.85 |
| Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC | 1.29 |
| Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC | 0.89 |
| Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC | 1.41 |
Number of Alcohol Drinks Chosen
The reinforcing effects of alcohol were determined using a self-administration procedure in which subjects choose to take previously sampled doses. Reinforcing effects are measured during maintenance on placebo and n-acetylcysteine. (NCT03216954)
Timeframe: After at least four days of placebo or n-acetylcysteine maintenance
| Intervention | Number of Alcohol Drinks Chosen (Mean) |
|---|
| Placebo | 3.1 |
| Low Dose n-Acetylcysteine | 2.8 |
| High Dose n-Acetylcysteine | 3.8 |
Prefrontal GABA+ Concentrations
Concentrations of GABA+, referenced to unsuppressed water and corrected for within-voxel CSF proportion, in dorsal anterior cingulate cortex measured via Proton Magnetic Resonance Spectroscopy (i.e., MEGA-PRESS). (NCT03220776)
Timeframe: Day 5 of each experimental condition
| Intervention | mmol/kg (Mean) |
|---|
| N-Acetylcysteine | 3.90 |
| Gabapentin | 3.93 |
| Placebo Oral Tablet | 3.73 |
Prefrontal Glx Concentrations
Concentrations of Glx (i.e., glutamate + glutamine), referenced to unsuppressed water and corrected for within-voxel CSF proportion, in dorsal anterior cingulate cortex measured via Proton Magnetic Resonance Spectroscopy. (NCT03220776)
Timeframe: Day 5 of each experimental condition
| Intervention | mmol/kg (Mean) |
|---|
| N-Acetylcysteine | 21.59 |
| Gabapentin | 21.69 |
| Placebo Oral Tablet | 22.25 |
Change in Neural Reactivity (as Measured by BOLD: Blood Oxygen Level-Dependent Response) in Reward Regions During Alcohol-cue Reactivity Task.
"Assessing the change in neural reactivity to alcohol cues after each round of medication: Placebo vs. N-Acetylcysteine.~Cue reactivity is a type of learned response which is observed in individuals who use substances (e.g., alcohol) and involves significant physiological reactions to presentations of substance-related stimuli (i.e., alcohol images) in comparison to neutral images (e.g., non-alcoholic beverages ) measured by BOLD (Blood Oxygen Level-Dependent response). ROIs were (left and right hemisphere): amygdala, caudate, insula, nucleus accumbens, and putamen.~Change in BOLD signal are reported in Z-scores. A Z-score of 0 would indicate there is no statistical difference in BOLD signal between alcohol images and non-alcohol beverage images. A higher Z-score would indicated a higher BOLD signal during alcohol images compared to non-alcohol beverage images. A lower Z-score would indicate a lower BOLD signal during alcohol images compared to non-alcohol beverage images." (NCT03238300)
Timeframe: 31 days total (levels compared after 10 days on N-Acetylcysteine and 10-days of placebo with 11 day washout period in between)
| Intervention | Z-score (Mean) |
|---|
| Left Amygdala | Right Amygdala | Left Caudate | Right Caudate | Left Insula | Right Insula | Left Nucleus Accumbens | Right Nucleus Accumbens | Left Putamen | Right Putamen |
|---|
| N-Acetylcysteine | 0.649576194 | 0.56294871 | 0.137316806 | 0.065642839 | -0.258198161 | -0.429143032 | 0.347468645 | 0.240204258 | -0.138118065 | -0.165481516 |
,| Placebo Oral Capsule | 0.3018234193548 | 0.210653871 | 0.110683871 | 0.031422161 | 0.058738871 | -0.169528194 | 0.2095879354838 | 0.072915871 | 0.225092871 | 0.058414516 |
Quantifying the Difference in Glutamate Levels (mmol/kg) During N-Acetylcysteine Versus Placebo in the Anterior Cingulate Brain Region.
"Using magnetic resonance spectroscopy and a within-subjects design, we will determine the effect of N-Acetylcysteine versus placebo on modulating anterior cingulate glutamate levels in adolescents. Values provided are absolute values (mmol/kg) at the end of each intervention period. Due to complexities of this method, normal levels of glutamate are not known; thus, we cannot make conclusions about the meaning of higher or lower glutamate levels when comparing N-acetylcysteine to placebo." (NCT03238300)
Timeframe: 31 days total (levels compared after 10 days on N-Acetylcysteine and 10-days of placebo with 11 day washout period in between)
| Intervention | mmol/kg (Mean) |
|---|
| N-Acetylcysteine | 15.7527667 |
| Placebo | 15.6265229 |
The Incidence of TA-TMA.
The incidence of TMA after HSCT. (NCT03252925)
Timeframe: 100 days
| Intervention | Participants (Count of Participants) |
|---|
| NAC Group | 5 |
| Placebo Group | 15 |
The Level of TNF-α
The level of TNF-α in patients post HSCT. (NCT03252925)
Timeframe: 40 days
| Intervention | pg/mL (Median) |
|---|
| NAC Group | 0.4 |
| Placebo Group | 0.3 |
Forced Expiratory Volume in One Second (FEV1) Measurement
Post-treatment FEV1 is reported. FEV1 is measured via spirometry. (NCT03581084)
Timeframe: end of the one week treatment period
| Intervention | liters (Number) |
|---|
| N-acetylcysteine | 0.86 |
Change From Baseline to Day 3 and to Day 7 of Mean Sputum Volume of NAC and Placebo
The superiority of the slow intravenous infusion of NAC to placebo in terms of change from baseline in sputum volume was demonstrated. Patients collected 24-hour sputum (morning to same time of the following morning) in a graduated cup and volume was expressed as mL/24h. (NCT03843541)
Timeframe: From Baseline upto Day 3 and Day 7
| Intervention | mL/24h (Mean) |
|---|
| Change from baseline to Day 3 | Change from baseline to Day 7 |
|---|
| N-Acetylcysteine | -1.601 | -9.405 |
,| Placebo | -4.144 | -7.391 |
Change From Baseline to Day 7 in Mean Expectoration Difficulty Score of NAC and Ambroxol Hydrochloride
The non-inferiority of NAC versus ambroxol in terms of change from baseline to Day 7 of mean expectoration difficulty score was demonstrated. Expectoration difficulty was assessed by ordinal categorical 4-point scales [0 = No difficulty, 1 = Mild difficulty, 2 = Moderate difficulty, 3 = Marked difficulty] with 0 = best and 3= worst (NCT03843541)
Timeframe: From Baseline upto Day 7
| Intervention | Score (Mean) |
|---|
| N-Acetylcysteine | -1.4 |
| Ambroxol Hydrochloride | -1.3 |
Change From Baseline to Day 7 in Mean Sputum Viscosity Score of NAC and Ambroxol Hydrochloride
The non-inferiority of NAC versus ambroxol in terms of change from baseline to Day 7 of mean sputum viscosity score was demonstrated. Sputum viscosity was assessed by ordinal categorical 4-point scales [0 = Liquid (normal viscosity), 1= Fluid (mildly increased viscosity), 2 = Viscous (moderately increased viscosity), 3 = Sticky (severely increased viscosity)] with 0 = best and 3= worst. (NCT03843541)
Timeframe: From baseline upto Day 7
| Intervention | Score (Mean) |
|---|
| N-Acetylcysteine | -1.2 |
| Ambroxol Hydrochloride | -1.2 |
Change From Baseline to Day 7 of Mean Sputum Viscosity Score of NAC and Placebo
The superiority of slow intravenous infusion of NAC to placebo in terms of change from baseline in sputum viscosity score was demonstrated. Sputum viscosity was assessed by ordinal categorical 4-point scales [0 = Liquid (normal viscosity), 1= Fluid (mildly increased viscosity), 2 = Viscous (moderately increased viscosity), 3 = Sticky (severely increased viscosity)] with 0 = best and 3= worst. (NCT03843541)
Timeframe: From baseline upto Day 7
| Intervention | Score (Mean) |
|---|
| N-Acetylcysteine | -1.2 |
| Placebo | -1.0 |
Number of Participants With Adverse Events
The safety and tolerability of intravenous NAC 600 mg twice daily was demonstrated. (NCT03843541)
Timeframe: From screening to follow-up after the last administration of the investigational medicinal product (IMP) [assessed up to 19 months]
| Intervention | Participants (Count of Participants) |
|---|
| At least one AE | At least one TEAE | At least one IMP-related TEAE | At least one TEAE leading to drug withdrawal | At least one TEAE leading to drug interruption | At least one TEAE leading to fatal outcome | At least one severe TEAE | At least one TEAE of COVID-19 | At least one SAE | At least one TESAE | At least one TESAE leading to drug withdrawal | At least one TESAE leading to drug interruption | At least one TESAE leading to fatal outcome | At least one TESAE of COVID-19 |
|---|
| Ambroxol Hydrochloride | 76 | 66 | 11 | 2 | 0 | 0 | 4 | 0 | 5 | 5 | 1 | 0 | 0 | 0 |
,| N-Acetylcysteine | 82 | 67 | 11 | 5 | 0 | 1 | 5 | 0 | 2 | 2 | 1 | 0 | 1 | 0 |
,| Placebo | 71 | 58 | 0 | 3 | 1 | 0 | 7 | 0 | 7 | 7 | 1 | 1 | 0 | 0 |
Change From Baseline to Day 3 and to Day 7 in Mean Cough Severity Score of Ambroxol Hydrochloride and Placebo
The superiority of slow intravenous infusion of ambroxol hydrochloride to placebo in terms of change from baseline in cough score was demonstrated. Cough score was assessed by means of ordinal categorical 4-point scales [0 = No cough, 1= Sporadic and mild cough, 2 = Moderate cough, 3 = Severe Cough] with 0 = best and 3= worst. (NCT03843541)
Timeframe: From Baseline upto Day 3 and Day 7
| Intervention | Score (Mean) |
|---|
| Change from baseline to Day 3 | Change from baseline to Day 7 |
|---|
| Ambroxol Hydrochloride | -0.4 | -0.7 |
,| Placebo | -0.5 | -0.6 |
Change From Baseline to Day 3 and to Day 7 in Mean Cough Severity Score of NAC and Placebo
The superiority of the slow intravenous infusion of NAC to placebo in terms of change from baseline in cough score was demonstrated. Cough score was assessed by means of ordinal categorical 4-point scales [0 = No cough, 1= Sporadic and mild cough, 2 = Moderate cough, 3 = Severe Cough] with 0 = best and 3= worst. (NCT03843541)
Timeframe: From Baseline upto Day 3 and Day 7
| Intervention | Score (Mean) |
|---|
| Change from baseline to Day 3 | Change from baseline to Day 7 |
|---|
| N-Acetylcysteine | -0.4 | -0.8 |
,| Placebo | -0.5 | -0.6 |
Change From Baseline to Day 3 and to Day 7 in Mean Expectoration Difficulty Score of Ambroxol Hydrochloride and Placebo
The superiority of the slow intravenous infusion of ambroxol hydrochloride to placebo in terms of change from baseline in expectoration difficulty score was demonstrated. Expectoration difficulty was assessed by ordinal categorical 4-point scales [0 = No difficulty, 1 = Mild difficulty, 2 = Moderate difficulty, 3 = Marked difficulty] with 0 = best and 3 = worst. (NCT03843541)
Timeframe: From Baseline upto Day 3 and Day 7
| Intervention | Score (Mean) |
|---|
| Change from baseline to Day 3 | Change from baseline to Day 7 |
|---|
| Ambroxol Hydrochloride | -0.7 | -1.3 |
,| Placebo | -0.7 | -1.1 |
Change From Baseline to Day 3 and to Day 7 in Mean Sputum Viscosity Score of Ambroxol Hydrochloride and Placebo
The superiority of the slow intravenous infusion ambroxol hydrochloride to placebo in terms of change from baseline in sputum viscosity score was demonstrated. Sputum viscosity was assessed by ordinal categorical 4-point scales [0 = Liquid (normal viscosity), 1= Fluid (mildly increased viscosity), 2 = Viscous (moderately increased viscosity), 3 = Sticky (severely increased viscosity)] with 0 = best and 3= worst. (NCT03843541)
Timeframe: From Baseline upto Day 3 and Day 7
| Intervention | Score (Mean) |
|---|
| Change from baseline to Day 3 | Change from baseline to Day 7 |
|---|
| Ambroxol Hydrochloride | -0.6 | -1.2 |
,| Placebo | -0.6 | -1.0 |
Change From Baseline to Day 3 and to Day 7 in Mean Sputum Color Score of Ambroxol Hydrochloride and Placebo
The superiority of slow intravenous infusion of ambroxol hydrochloride to placebo in terms of change from baseline in sputum color was demonstrated. Sputum color was assessed by means of ordinal categorical 4-point scales [0 = Mostly white, 1= Mostly pale yellow, 2 = Mostly dark yellow, 3 = Very dark yellow /green] with 0 = best and 3= worst. (NCT03843541)
Timeframe: From Baseline upto Day 3 and Day 7
| Intervention | Score (Mean) |
|---|
| Change from baseline to Day 3 | Change from baseline to Day 7 |
|---|
| Ambroxol Hydrochloride | -0.5 | -0.9 |
,| Placebo | -0.5 | -0.8 |
Change From Baseline to Day 3 and to Day 7 in Mean Sputum Color Score of NAC and Placebo
The superiority of the slow intravenous infusion of NAC to placebo in terms of change from baseline in sputum color score was demonstrated. Sputum color was assessed by means of ordinal categorical 4-point scales [0 = Mostly white, 1= Mostly pale yellow, 2 = Mostly dark yellow, 3 = Very dark yellow /green] with 0 = best and 3= worst. (NCT03843541)
Timeframe: From Baseline upto Day 3 and Day 7
| Intervention | Score (Mean) |
|---|
| Change from baseline to Day 3 | Change from baseline to Day 7 |
|---|
| N-Acetylcysteine | -0.5 | -0.8 |
,| Placebo | -0.5 | -0.8 |
Change From Baseline to Day 3 and to Day 7 in Mean Sputum Volume of Ambroxol Hydrochloride and Placebo
The superiority of slow intravenous infusion of ambroxol hydrochloride to placebo in terms of change from baseline in mean sputum volume was demonstrated. Patients collected 24-hour sputum (morning to same time of the following morning) in a graduated cup and volume was expressed as mL/24h. (NCT03843541)
Timeframe: From Baseline upto Day 3 and Day 7
| Intervention | mL/24h (Mean) |
|---|
| Change from baseline to Day 3 | Change from baseline to Day 7 |
|---|
| Ambroxol Hydrochloride | -4.53 | -9.73 |
,| Placebo | -4.14 | -7.39 |
Change From Baseline to Day 7 Treatment of Mean Expectoration Difficulty Score of NAC and Placebo
The superiority of slow intravenous infusion of NAC 600 mg twice daily to placebo in terms of change from baseline in expectoration difficulty score was demonstrated. Expectoration difficulty was assessed by ordinal categorical 4-point scales [0 = No difficulty, 1 = Mild difficulty, 2 = Moderate difficulty, 3 = Marked difficulty] with 0 = best and 3 = worst. (NCT03843541)
Timeframe: From Baseline upto Day 7
| Intervention | Score (Mean) |
|---|
| N-Acetylcysteine | -1.4 |
| Placebo | -1.1 |
Change From Baseline to Day 3 in Mean Sputum Viscosity Score of NAC and Placebo
The superiority of slow intravenous infusion of NAC to placebo in terms of change from baseline in sputum viscosity score was demonstrated. Sputum viscosity was assessed by ordinal categorical 4-point scales [0 = Liquid (normal viscosity), 1= Fluid (mildly increased viscosity), 2 = Viscous (moderately increased viscosity), 3 = Sticky (severely increased viscosity)] with 0 = best and 3= worst. (NCT03843541)
Timeframe: From Baseline to Day 3
| Intervention | Score (Mean) |
|---|
| N-Acetylcysteine | -0.6 |
| Placebo | -0.6 |
Change From Baseline to Day 3 in Mean Expectoration Difficulty Score of NAC and Placebo
The superiority of slow intravenous infusion of NAC to placebo in terms of change from baseline in expectoration difficulty score was demonstrated. Expectoration difficulty was assessed by ordinal categorical 4-point scales [0 = No difficulty, 1 = Mild difficulty, 2 = Moderate difficulty, 3 = Marked difficulty] with 0 = best and 3 = worst. (NCT03843541)
Timeframe: From Baseline to Day 3
| Intervention | Score (Mean) |
|---|
| N-Acetylcysteine | -0.8 |
| Placebo | -0.7 |
Total Body Clearance (CLt) After Single Dose of NAC
To evaluate pharmacokinetic parameters of NAC in plasma after single dose administration of the investigational product. (NCT03881163)
Timeframe: On Day 1 and Day 2-At pre-dose (0) and 5 (at the end of the infusion), 8, 12, 15, 20, 25, 30, 60 minutes and 2, 4, 6, 8, 10, 12, 24 and 32 hours post-dose.
| Intervention | Literhour (Geometric Mean) |
|---|
| Single Dose - NAC 600mg | 6.387 |
Total Amount of NAC Excreted in Urine From the Last Multiple Dose to 32 h at Steady-state [Aess(0-32)]
To evaluate pharmacokinetic parameters of NAC in plasma after multiple dose administration of the investigational product. (NCT03881163)
Timeframe: On Day 4 and Day 5 -At pre-dose. On Day 6 and Day 7-At pre-dose (0) and 5 (at the end of the infusion), 8, 12, 15, 20, 25, 30, 60 minutes and 2, 4, 6, 8, 10, 12, 24 and 32 hours post-dose.
| Intervention | μg (Geometric Mean) |
|---|
| Multiple Dose - NAC 600mg | 68980 |
Time to Achieve Css_max (tss_max) After Multiple Doses of NAC
To evaluate pharmacokinetic parameters of NAC in plasma after multiple dose administration of the investigational product. (NCT03881163)
Timeframe: On Day 4 and Day 5 -At pre-dose. On Day 6 and Day 7-At pre-dose (0) and 5 (at the end of the infusion), 8, 12, 15, 20, 25, 30, 60 minutes and 2, 4, 6, 8, 10, 12, 24 and 32 hours post-dose.
| Intervention | hour (Median) |
|---|
| Multiple Dose - NAC 600mg | 0.083 |
Time to Achieve Cmax (Tmax) After Single Dose of NAC
To evaluate pharmacokinetic parameters of NAC in plasma after single dose administration of the investigational product. (NCT03881163)
Timeframe: On Day 1 and Day 2-At pre-dose (0) and 5 (at the end of the infusion), 8, 12, 15, 20, 25, 30, 60 minutes and 2, 4, 6, 8, 10, 12, 24 and 32 hours post-dose.
| Intervention | hours (Median) |
|---|
| Single Dose - NAC 600mg | 0.083 |
Terminal Elimination Rate Constant (Kel) After Single Dose of NAC
To evaluate pharmacokinetic parameters of NAC in plasma after single dose administration of the investigational product. (NCT03881163)
Timeframe: On Day 1 and Day 2-At pre-dose (0) and 5 (at the end of the infusion), 8, 12, 15, 20, 25, 30, 60 minutes and 2, 4, 6, 8, 10, 12, 24 and 32 hours post-dose.
| Intervention | 1/hour (Geometric Mean) |
|---|
| Single Dose - NAC 600mg | 0.09723 |
Percentage of the AUC(0-inf) Obtained by Extrapolation (%AUCextra)
To evaluate pharmacokinetic parameters of NAC in plasma after single dose administration of the investigational product. (NCT03881163)
Timeframe: On Day 1 and Day 2-At pre-dose (0) and 5 (at the end of the infusion), 8, 12, 15, 20, 25, 30, 60 minutes and 2, 4, 6, 8, 10, 12, 24 and 32 hours post-dose.
| Intervention | percentage (Geometric Mean) |
|---|
| Single Dose - NAC 600mg | 6.967 |
Half-life (t1/2) After Single Dose of NAC
To evaluate pharmacokinetic parameters of NAC in plasma after single dose administration of the investigational product. (NCT03881163)
Timeframe: On Day 1 and Day 2-At pre-dose (0) and 5 (at the end of the infusion), 8, 12, 15, 20, 25, 30, 60 minutes and 2, 4, 6, 8, 10, 12, 24 and 32 hours post-dose.
| Intervention | hour (Geometric Mean) |
|---|
| Single Dose - NAC 600mg | 7.129 |
Degree of Fluctuation Over One Dosing Interval at Steady-state (DF%) After Multiple Dose of NAC
"To evaluate pharmacokinetic parameters of NAC in plasma after multiple dose administration of the investigational product.~Degree of fluctuation over one dosing interval at steady-state is calculated as (Css_max - Css_min)/ Css_av*100" (NCT03881163)
Timeframe: On Day 4 and Day 5 -At pre-dose. On Day 6 and Day 7-At pre-dose (0) and 5 (at the end of the infusion), 8, 12, 15, 20, 25, 30, 60 minutes and 2, 4, 6, 8, 10, 12, 24 and 32 hours post-dose.
| Intervention | percentage (Geometric Mean) |
|---|
| Multiple Dose - NAC 600mg | 1279 |
Accumulation Ratio After Multiple Doses of NAC
To evaluate pharmacokinetic parameters of NAC in plasma after multiple dose administration of the investigational product. (NCT03881163)
Timeframe: On Day 4 and Day 5 -At pre-dose. On Day 6 and Day 7-At pre-dose (0) and 5 (at the end of the infusion), 8, 12, 15, 20, 25, 30, 60 minutes and 2, 4, 6, 8, 10, 12, 24 and 32 hours post-dose.
| Intervention | Ratio (Geometric Mean) |
|---|
| Multiple Dose - NAC 600mg | 1.132 |
Total Fraction of NAC Dose Excreted in Urine [Fe(0-t)] After Single Dose of NAC
To evaluate pharmacokinetic parameters of NAC in plasma after single dose administration of the investigational product. (NCT03881163)
Timeframe: On Day 1 and Day 2-At pre-dose (0) and 5 (at the end of the infusion), 8, 12, 15, 20, 25, 30, 60 minutes and 2, 4, 6, 8, 10, 12, 24 and 32 hours post-dose.
| Intervention | fraction (Geometric Mean) |
|---|
| Fe(0-4) | Fe(0-8) | Fe(0-12) | Fe(0-24) | Fe(0-32) |
|---|
| Single Dose - NAC 600mg | 0.1046 | 0.1400 | 0.1493 | 0.1534 | 0.1558 |
Peak Drug Concentration (Cmax) After Single Dose of NAC
To evaluate pharmacokinetic parameters of NAC in plasma after single administration of the investigational product. (NCT03881163)
Timeframe: On Day 1 and Day 2-At pre-dose (0) and 5 (at the end of the infusion), 8, 12, 15, 20, 25, 30, 60 minutes and 2, 4, 6, 8, 10, 12, 24 and 32 hours post-dose
| Intervention | µg/mL (Geometric Mean) |
|---|
| Single Dose - NAC 600mg | 83.30 |
Renal Clearance (CLr) After Single Dose of NAC
To evaluate pharmacokinetic parameters of NAC in plasma after single dose administration of the investigational product. (NCT03881163)
Timeframe: On Day 1 and Day 2-At pre-dose (0) and 5 (at the end of the infusion), 8, 12, 15, 20, 25, 30, 60 minutes and 2, 4, 6, 8, 10, 12, 24 and 32 hours post-dose.
| Intervention | mL/h (Geometric Mean) |
|---|
| Single Dose - NAC 600mg | 995.2 |
Volume of Distribution (Vd) After Single Dose of NAC
To evaluate pharmacokinetic parameters of NAC in plasma after single dose administration of the investigational product. (NCT03881163)
Timeframe: On Day 1 and Day 2-At pre-dose (0) and 5 (at the end of the infusion), 8, 12, 15, 20, 25, 30, 60 minutes and 2, 4, 6, 8, 10, 12, 24 and 32 hours post-dose.
| Intervention | litre (Geometric Mean) |
|---|
| Single Dose - NAC 600mg | 65.69 |
Plasma Concentration at Steady-state After Multiple Doses of NAC
"To evaluate pharmacokinetic parameters of NAC in plasma after multiple dose administration of the investigational product.~Css_max = maximum NAC plasma concentration at steady-state, Css_min=minimum plasma concentration at steady-state, Css_avg=average NAC plasma concentration at steady-state." (NCT03881163)
Timeframe: On Day 4 and Day 5 -At pre-dose. On Day 6 and Day 7-At pre-dose (0) and 5 (at the end of the infusion), 8, 12, 15, 20, 25, 30, 60 minutes and 2, 4, 6, 8, 10, 12, 24 and 32 hours post-dose.
| Intervention | µg/mL (Geometric Mean) |
|---|
| Css_max | Css_min | Css_avg |
|---|
| Multiple Dose - NAC 600mg | 100.8 | 1.899 | 7.719 |
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
To collect safety and tolerability data after single and multiple dose administration of the investigational product. (NCT03881163)
Timeframe: From screening to Final Visit/early termination visit (ETV, Day 8)
| Intervention | Participants (Count of Participants) |
|---|
| Any TEAE | Any TEAE Related to investigational medicinal product |
|---|
| NAC 600 mg | 7 | 2 |
Area Under the Concentration-time Curve at Steady State After Multiple Doses of NAC
"To evaluate pharmacokinetic parameters of NAC in plasma after multiple dose administration of the investigational product.~AUCss(0-12h)=AUC at steady-state from the last multiple dose to 12 hours post-dose, AUCss(0-t)=AUC at steady-state from the last multiple dose to the last observed concentration time t." (NCT03881163)
Timeframe: On Day 4 and Day 5 -At pre-dose. On Day 6 and Day 7-At pre-dose (0) and 5 (at the end of the infusion), 8, 12, 15, 20, 25, 30, 60 minutes and 2, 4, 6, 8, 10, 12, 24 and 32 hours post-dose.
| Intervention | h*µg/mL (Geometric Mean) |
|---|
| AUCss(0-t) | AUCss(0-12h) |
|---|
| Multiple Dose - NAC 600mg | 116.6 | 92.63 |
Total Amount of NAC Excreted in Urine [Ae(0-t)] After Single Dose of NAC
To evaluate pharmacokinetic parameters of NAC in plasma after single dose administration of the investigational product. (NCT03881163)
Timeframe: On Day 1 and Day 2-At pre-dose (0) and 5 (at the end of the infusion), 8, 12, 15, 20, 25, 30, 60 minutes and 2, 4, 6, 8, 10, 12, 24 and 32 hours post-dose.
| Intervention | μg (Geometric Mean) |
|---|
| Ae(0-4) | Ae(4-8) | Ae(8-12) | Ae(12-24) | Ae(24-32) | Ae(0-8) | Ae(0-12) | Ae(0-24) | Ae(0-32) |
|---|
| Single Dose - NAC 600mg | 62750 | 16170 | 3609 | 1846 | 1366 | 84020 | 89600 | 92020 | 93490 |
Area Under the Concentration-time Curve (AUC) After Single Dose of NAC
To evaluate pharmacokinetic parameters of NAC in plasma after single dose administration of the investigational product. (NCT03881163)
Timeframe: On Day 1 and Day 2-At pre-dose (0) and 5 (at the end of the infusion), 8, 12, 15, 20, 25, 30, 60 minutes and 2, 4, 6, 8, 10, 12, 24 and 32 hours post-dose.
| Intervention | h*µg/mL (Geometric Mean) |
|---|
| AUC from time zero to the last observed concentration time t [AUC(0-t)] | AUC extrapolated to infinity [AUC(0-inf)] | AUC from time zero to 12 hours post-dose [AUC(0-12h)] |
|---|
| Single Dose - NAC 600mg | 87.16 | 93.94 | 81.87 |
Change in Glutamate Concentrations
Percent decrease in the concentrations of glutamate (GLU) in the anterior cingulate cortex (ACC) measured by MRS (NCT04005053)
Timeframe: 28 days
| Intervention | percent change (Mean) |
|---|
| Low-Dose NAC | -0.9 |
| High-Dose NAC | -1.2 |
| Placebo | -0.8 |
Change in GSH Reduced-to-oxidized Ratio
Percent increase in reduced-to-oxidized ratio of glutathione (GSH) in the blood compared to baseline (NCT04005053)
Timeframe: 28 days
| Intervention | percent change (Mean) |
|---|
| Low-Dose NAC | 14 |
| High-Dose NAC | 28 |
| Placebo | -5 |
Percent Increase in Glutathione (GSH) Concentrations in the ACC
increase in glutathione (GSH) concentrations in the anterior cingulate cortex (ACC) as measured by magnetic resonance spectroscopy (MRS) (NCT04005053)
Timeframe: 28 days
| Intervention | Percent change (Mean) |
|---|
| Low-Dose NAC | 5 |
| High-Dose NAC | 0 |
| Placebo | 2 |
Number of Responders and Non-responders to Treatment, Per-Protocol Set
Number of responders and non-responders to treatment based on the assessment of overall response to treatment by the investigator were reported. (NCT04123405)
Timeframe: Day 4, 7, 10 and 15
| Intervention | Participants (Count of Participants) |
|---|
| Day 472522624 | Day 472522625 | Day 472522626 | Day 472522627 | Day 772522625 | Day 772522626 | Day 772522624 | Day 772522627 | Day 1072522626 | Day 1072522624 | Day 1072522625 | Day 1072522627 | Day 1572522624 | Day 1572522625 | Day 1572522626 | Day 1572522627 |
|---|
| Responders | Non-responders |
|---|
| Group A: 600 mg Acetylcysteine | 138 |
| Group B: 1200 mg Acetylcysteine | 140 |
| Group C: 2400 mg Acetylcysteine | 132 |
| Group D: Placebo | 134 |
| Group A: 600 mg Acetylcysteine | 75 |
| Group B: 1200 mg Acetylcysteine | 75 |
| Group C: 2400 mg Acetylcysteine | 80 |
| Group D: Placebo | 73 |
| Group A: 600 mg Acetylcysteine | 192 |
| Group B: 1200 mg Acetylcysteine | 190 |
| Group C: 2400 mg Acetylcysteine | 191 |
| Group D: Placebo | 192 |
| Group A: 600 mg Acetylcysteine | 21 |
| Group B: 1200 mg Acetylcysteine | 25 |
| Group C: 2400 mg Acetylcysteine | 21 |
| Group D: Placebo | 15 |
| Group A: 600 mg Acetylcysteine | 207 |
| Group C: 2400 mg Acetylcysteine | 209 |
| Group D: Placebo | 202 |
| Group A: 600 mg Acetylcysteine | 6 |
| Group C: 2400 mg Acetylcysteine | 3 |
| Group D: Placebo | 5 |
| Group A: 600 mg Acetylcysteine | 211 |
| Group B: 1200 mg Acetylcysteine | 210 |
| Group C: 2400 mg Acetylcysteine | 206 |
| Group D: Placebo | 205 |
| Group A: 600 mg Acetylcysteine | 2 |
| Group B: 1200 mg Acetylcysteine | 5 |
| Group C: 2400 mg Acetylcysteine | 6 |
| Group D: Placebo | 2 |
Number of Responders and Non-responders to Treatment, Full Analysis Set
Number of responders and non-responders to treatment based on the assessment of overall response to treatment by the investigator were reported. (NCT04123405)
Timeframe: Day 4, 7, 10 and 15
| Intervention | Participants (Count of Participants) |
|---|
| Day 472522624 | Day 472522625 | Day 472522626 | Day 472522627 | Day 772522624 | Day 772522625 | Day 772522626 | Day 772522627 | Day 1072522624 | Day 1072522626 | Day 1072522627 | Day 1072522625 | Day 1572522624 | Day 1572522625 | Day 1572522626 | Day 1572522627 |
|---|
| Responders | Non-responders |
|---|
| Group A: 600 mg Acetylcysteine | 148 |
| Group B: 1200 mg Acetylcysteine | 152 |
| Group C: 2400 mg Acetylcysteine | 151 |
| Group D: Placebo | 150 |
| Group A: 600 mg Acetylcysteine | 85 |
| Group B: 1200 mg Acetylcysteine | 83 |
| Group C: 2400 mg Acetylcysteine | 86 |
| Group D: Placebo | 79 |
| Group A: 600 mg Acetylcysteine | 209 |
| Group B: 1200 mg Acetylcysteine | 206 |
| Group C: 2400 mg Acetylcysteine | 212 |
| Group D: Placebo | 209 |
| Group A: 600 mg Acetylcysteine | 23 |
| Group B: 1200 mg Acetylcysteine | 29 |
| Group C: 2400 mg Acetylcysteine | 15 |
| Group D: Placebo | 18 |
| Group A: 600 mg Acetylcysteine | 225 |
| Group B: 1200 mg Acetylcysteine | 225 |
| Group C: 2400 mg Acetylcysteine | 230 |
| Group D: Placebo | 219 |
| Group A: 600 mg Acetylcysteine | 6 |
| Group B: 1200 mg Acetylcysteine | 7 |
| Group C: 2400 mg Acetylcysteine | 5 |
| Group D: Placebo | 6 |
| Group A: 600 mg Acetylcysteine | 230 |
| Group B: 1200 mg Acetylcysteine | 226 |
| Group D: Placebo | 224 |
| Group A: 600 mg Acetylcysteine | 4 |
| Group B: 1200 mg Acetylcysteine | 6 |
| Group C: 2400 mg Acetylcysteine | 8 |
| Group D: Placebo | 4 |
Sino-Nasal Outcome Test (SNOT-22) by Visit, Full Analysis Set
SNOT-22 Questionnaire is a disease specific Health-Related Quality of Life (HRQoL) measure that comprises a list of 22 symptoms and social or emotional consequences of the nasal disorder. Every participant is asked to rate how severe each problem had been on a scale from 0 (no problem) to 5 (problem as bad as it can be). The total score is the sum of the scores for all 22 items, ranging from 0 to 110, with a lower score indicating better HRQoL. (NCT04123405)
Timeframe: Baseline (Day 1), Day 7 and Day 14
| Intervention | Score on a scale (Mean) |
|---|
| Day 1 (Baseline) | Day 7 | Day 14 |
|---|
| Group A: 600 mg Acetylcysteine | 37.8 | 23.6 | 7.2 |
,| Group B: 1200 mg Acetylcysteine | 36.3 | 21.2 | 6.9 |
,| Group C: 2400 mg Acetylcysteine | 36.7 | 22.3 | 7.0 |
,| Group D: Placebo | 36.3 | 21.1 | 6.5 |
Time to Onset of Action, Full Analysis Set
Time to onset of action was defined as first day of active treatment on which MSS showed statistically significant (p value<0.05) improvement from placebo. (NCT04123405)
Timeframe: Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15
| Intervention | Days (Number) |
|---|
| Group A: 600 mg Acetylcysteine | NA |
| Group B: 1200 mg Acetylcysteine | NA |
| Group C: 2400 mg Acetylcysteine | NA |
Sino-Nasal Outcome Test (SNOT-22) by Visit, Per Protocol Set
SNOT-22 Questionnaire is a disease specific Health-Related Quality of Life (HRQoL) measure that comprises a list of 22 symptoms and social or emotional consequences of the nasal disorder. Every participant is asked to rate how severe each problem had been on a scale from 0 (no problem) to 5 (problem as bad as it can be). The total score is the sum of the scores for all 22 items, ranging from 0 to 110, with a lower score indicating better HRQoL. (NCT04123405)
Timeframe: Baseline (Day 1), Day 7 and Day 14
| Intervention | Score on a scale (Mean) |
|---|
| Day 1 (Baseline) | Day 7 | Day 14 |
|---|
| Group A: 600 mg Acetylcysteine | 37.7 | 23.3 | 6.9 |
,| Group B: 1200 mg Acetylcysteine | 36.7 | 21.2 | 7.1 |
,| Group C: 2400 mg Acetylcysteine | 36.4 | 22.2 | 6.8 |
,| Group D: Placebo | 36.2 | 21.0 | 6.6 |
Time to Onset of Action, Per-Protocol Set
Time to onset of action was defined as first day of active treatment on which MSS showed statistically significant (p value<0.05) improvement from placebo. (NCT04123405)
Timeframe: Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15
| Intervention | Days (Number) |
|---|
| Group A: 600 mg Acetylcysteine | NA |
| Group B: 1200 mg Acetylcysteine | NA |
| Group C: 2400 mg Acetylcysteine | NA |
Mean Change From Baseline in the Daily Major Symptom Score (MSS) Over the Entire Treatment Period, Full Analysis Set
"The MSS combines the 5 most relevant symptoms of rhinosinusitis based on expert clinician recommendations (rhinorrhea/ anterior discharge, postnasal drip, nasal congestion, headache, and facial pain/pressure). The patient rated the severity of each of the five symptoms of the MSS using a four-point rating scale of increasing severity (0 = none/not present, 1 = mild, 2 = moderate, 3 = severe). The MSS is then the sum of single ratings with a possible range from 0 to 15.~Mean change from baseline in the daily Major Symptom Score (MSS) over the entire treatment period was calculated as the average total score from Day 2 to 15 compared to Baseline (Day 1). Negative change from baseline means improvement." (NCT04123405)
Timeframe: Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15
| Intervention | Score on a scale (Mean) |
|---|
| Group A: 600 mg Acetylcysteine | -4.8213 |
| Group B: 1200 mg Acetylcysteine | -4.7394 |
| Group C: 2400 mg Acetylcysteine | -4.7758 |
| Group D: Placebo | -5.0180 |
Major Symptom Score (MSS) Development Over the Course of the Study, Full Analysis Set
"The MSS combines the 5 most relevant symptoms of rhinosinusitis based on expert clinician recommendations (rhinorrhea/ anterior discharge, postnasal drip, nasal congestion, headache, and facial pain/pressure). The patient rated the severity of each of the five symptoms of the MSS using a four-point rating scale of increasing severity (0 = none/not present, 1 = mild, 2 = moderate, 3 = severe). The MSS is then the sum of single ratings with a possible range from 0 to 15.~Mean change from baseline in the daily Major Symptom Score (MSS) over the entire treatment period was calculated as the average total score from Day 2 to 15 compared to Baseline (Day 1). Negative change from baseline means improvement." (NCT04123405)
Timeframe: Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15
| Intervention | Score on a scale (Mean) |
|---|
| Day 1 (Baseline) | Day 2 | Day 3 | Day 4 | Day 5 | Day 6 | Day 7 | Day 8 | Day 9 | Day 10 | Day 11 | Day 12 | Day 13 | Day 14 | Day 15 |
|---|
| Group A: 600 mg Acetylcysteine | 9.634 | 9.021 | 8.485 | 7.821 | 6.983 | 6.323 | 5.528 | 4.766 | 4.204 | 3.634 | 3.051 | 2.609 | 2.038 | 1.583 | 1.332 |
,| Group B: 1200 mg Acetylcysteine | 9.640 | 9.004 | 8.513 | 7.695 | 6.979 | 6.203 | 5.538 | 4.750 | 4.322 | 3.763 | 3.284 | 2.754 | 2.246 | 1.941 | 1.614 |
,| Group C: 2400 mg Acetylcysteine | 9.702 | 9.038 | 8.416 | 7.723 | 7.013 | 6.315 | 5.576 | 4.891 | 4.445 | 3.845 | 3.256 | 2.756 | 2.218 | 1.836 | 1.634 |
,| Group D: Placebo | 9.683 | 9.074 | 8.609 | 7.761 | 6.917 | 6.039 | 5.126 | 4.387 | 3.839 | 3.404 | 2.843 | 2.413 | 1.943 | 1.596 | 1.352 |
Major Symptom Score (MSS) Development Over the Course of the Study, Per-protocol Set
"The MSS combines the 5 most relevant symptoms of rhinosinusitis based on expert clinician recommendations (rhinorrhea/ anterior discharge, postnasal drip, nasal congestion, headache, and facial pain/pressure). The patient rated the severity of each of the five symptoms of the MSS using a four-point rating scale of increasing severity (0 = none/not present, 1 = mild, 2 = moderate, 3 = severe). The MSS is then the sum of single ratings with a possible range from 0 to 15.~Mean change from baseline in the daily Major Symptom Score (MSS) over the entire treatment period was calculated as the average total score from Day 2 to 15 compared to Baseline (Day 1). Negative change from baseline means improvement." (NCT04123405)
Timeframe: Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15
| Intervention | Score on a scale (Mean) |
|---|
| Day 1 (Baseline) | Day 2 | Day 3 | Day 4 | Day 5 | Day 6 | Day 7 | Day 8 | Day 9 | Day 10 | Day 11 | Day 12 | Day 13 | Day 14 | Day 15 |
|---|
| Group A: 600 mg Acetylcysteine | 9.657 | 9.080 | 8.545 | 7.803 | 6.962 | 6.315 | 5.479 | 4.685 | 4.117 | 3.521 | 2.934 | 2.493 | 1.897 | 1.432 | 1.221 |
,| Group B: 1200 mg Acetylcysteine | 9.628 | 8.935 | 8.395 | 7.577 | 6.874 | 6.093 | 5.400 | 4.605 | 4.181 | 3.628 | 3.144 | 2.572 | 2.065 | 1.749 | 1.409 |
,| Group C: 2400 mg Acetylcysteine | 9.698 | 9.127 | 8.528 | 7.816 | 7.061 | 6.349 | 5.604 | 4.892 | 4.382 | 3.741 | 3.146 | 2.608 | 2.085 | 1.708 | 1.524 |
,| Group D: Placebo | 9.676 | 9.068 | 8.594 | 7.739 | 6.821 | 5.937 | 4.981 | 4.237 | 3.652 | 3.222 | 2.705 | 2.300 | 1.816 | 1.444 | 1.193 |
Sino-Nasal Outcome Test (SNOT-22) by Change to Baseline, Full Analysis Set
SNOT-22 Questionnaire is a disease specific Health-Related Quality of Life (HRQoL) measure that comprises a list of 22 symptoms and social or emotional consequences of the nasal disorder. Every participant is asked to rate how severe each problem had been on a scale from 0 (no problem) to 5 (problem as bad as it can be). The total score is the sum of the scores for all 22 items, ranging from 0 to 110, with a lower score indicating better HRQoL. A negative change from baseline in SNOT-22 is considered a favorable outcome. (NCT04123405)
Timeframe: Baseline (Day 1), Day 7 and Day 14
| Intervention | Score on a scale (Mean) |
|---|
| Day 7 | Day 14 |
|---|
| Group A: 600 mg Acetylcysteine | -35.8 | -79.3 |
,| Group B: 1200 mg Acetylcysteine | -38.2 | -78.9 |
,| Group C: 2400 mg Acetylcysteine | -36.7 | -78.6 |
,| Group D: Placebo | -39.6 | -81.5 |
Mean Change From Baseline in the Daily Major Symptom Score (MSS) Over the Entire Treatment Period, Per-Protocol Set
"The MSS combines the 5 most relevant symptoms of rhinosinusitis based on expert clinician recommendations (rhinorrhea/ anterior discharge, postnasal drip, nasal congestion, headache, and facial pain/pressure). The patient rated the severity of each of the five symptoms of the MSS using a four-point rating scale of increasing severity (0 = none/not present, 1 = mild, 2 = moderate, 3 = severe). The MSS is then the sum of single ratings with a possible range from 0 to 15.~Mean change from baseline in the daily Major Symptom Score (MSS) over the entire treatment period was calculated as the average total score from Day 2 to 15 compared to Baseline (Day 1). Negative change from baseline means improvement." (NCT04123405)
Timeframe: Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15
| Intervention | Score on a scale (Mean) |
|---|
| Group A: 600 mg Acetylcysteine | -4.9085 |
| Group B: 1200 mg Acetylcysteine | -4.8688 |
| Group C: 2400 mg Acetylcysteine | -4.8002 |
| Group D: Placebo | -5.1256 |
Sino-Nasal Outcome Test (SNOT-22) by Change to Baseline, Per Protocol Set
SNOT-22 Questionnaire is a disease specific Health-Related Quality of Life (HRQoL) measure that comprises a list of 22 symptoms and social or emotional consequences of the nasal disorder. Every participant is asked to rate how severe each problem had been on a scale from 0 (no problem) to 5 (problem as bad as it can be). The total score is the sum of the scores for all 22 items, ranging from 0 to 110, with a lower score indicating better HRQoL. A negative change from baseline in SNOT-22 is considered a favorable outcome. (NCT04123405)
Timeframe: Baseline (Day 1), Day 7 and Day 14
| Intervention | Score on a scale (Mean) |
|---|
| Day 7 | Day 14 |
|---|
| Group A: 600 mg Acetylcysteine | -36.4 | -79.8 |
,| Group B: 1200 mg Acetylcysteine | -39.5 | -78.6 |
,| Group C: 2400 mg Acetylcysteine | -36.7 | -79.1 |
,| Group D: Placebo | -39.6 | -81.0 |
Change From Baseline in Motor Function Measured by Physical and Neurological Examination for Subtle Signs (PANESS)
Characterize effects of NAC treatment on motor function in kids with NF1 using the Physical and Neurological Examination for Subtle Signs (PANESS). This is a validated scale that consistently demonstrates significant impairments in children with ADHD, and which preliminary data suggest may demonstrate more extreme problems in children with NF1 than age-matched healthy controls (unpublished data from CCHMC). The investigators hypothesize that motor function scores rated with the PANESS scale will improve after treatment with NAC. The range of this scale is 0-119, higher scores correlate with symptom severity (worse outcome). (NCT04481035)
Timeframe: At baseline and end of 8 weeks treatment with either NAC or placebo (weeks 0 and 8 for treatment phase one of this cross-over double blind study and at weeks 10 and 18 for treatment phase two).
| Intervention | score on a scale (Median) |
|---|
| N-Acetylcysteine | 0 |
| Placebo | 3 |
Transcranial Magnetic Stimulation (TMS) - Cortical Silent Period
"Transcranial Magnetic Stimulation (TMS) - Cortical Silent Period (CSP). This measure describes the function and physiology of the motor system using Transcranial Magnetic Stimulation (TMS) over the brain to evoke a muscle twitch in the hand. These evoked potentials provide information about the instantaneous balance of excitation and inhibition in the brain, which in turn relate in part to neurotransmitter levels that can be altered by diseases and by treatments. This measure reflects an inhibitory neurotransmitter called GABA-B and its action at a particular receptor - the GABA B receptor. A lengthening of the duration of CSP indicates more inhibition, which is good (within a healthy range of approximately 50 to 150 ms, because outside of that range is abnormal). Here we report the average difference before and after treatment." (NCT04481035)
Timeframe: At baseline and end of 8 weeks treatment with either NAC or placebo (weeks 0 and 8 for treatment phase one of this cross-over double blind study and at weeks 10 and 18 for treatment phase two).
| Intervention | ms (Mean) |
|---|
| N-Acetylcysteine | 6 |
| Placebo | -4 |
Change From Baseline in ADHD Symptoms as Reported Via Parent/Teacher Surveys
Characterize effects of NAC treatment on ADHD symptoms in children with NF1. The investigators hypothesize that ADHD attention and hyperactive/impulsive symptoms, rated with the DuPaul DSM-5 based clinical rating scales, will improve after treatment with NAC. The range of this scale is 0-56, higher scores correlate with symptom severity (worse outcome). (NCT04481035)
Timeframe: At baseline and end of 8 weeks treatment with either NAC or placebo (weeks 0 and 8 for treatment phase one of this cross-over double blind study and at weeks 10 and 18 for treatment phase two).
| Intervention | units on a scale (Mean) |
|---|
| N-Acetylcysteine | -12.5 |
| Placebo | -3.75 |
Time to Symptom Resolution
Days to resolution of symptoms of infection. (NCT04545008)
Timeframe: 0 to 30 days
| Intervention | days (Mean) |
|---|
| Low Dose N-Acetyl Cysteine Alone | 6 |
Rate of Hospitalization
Number of participants hospitalized (NCT04545008)
Timeframe: 0 to 30 days
| Intervention | participants (Number) |
|---|
| Low Dose N-Acetyl Cysteine Alone | 0 |
Change in Abdominal Pain
"Change in severity of abdominal pain from baseline, as determined from weekly average visual analog scale (VAS) scores, relative to Rifaximin alone. VAS scores allows subject to choose 0 for no pain to 100 pain as bad as it could possibly be.~The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 no pain and 100 pain as bad as it could possibly be~The change between two time points is reported baseline and 4 weeks after cessation of treatment (at 6 weeks)" (NCT04557215)
Timeframe: value at 6 weeks minus value at baseline
| Intervention | units on a scale (Mean) |
|---|
| Rifaximin 550 mg | -5.43 |
| Rifaximin 200 mg + Placebo | -8.90 |
| Rifaximin 200 mg Plus N-acetylcysteine (NAC) 600 mg Days | -5.59 |
Opioid Consumption Every 6 Hours Post Operative
Post operative opioid consumption ry 6 hours post operative. Data are reported as mean (95% CI) or mean difference (95% CI) estimated from a linear mixed model of opioid consumption over time including main effects for treatment group, postoperative time, and the interaction between treatment group and postoperative time and a random subject effect. (NCT04562597)
Timeframe: 6-48 hours
| Intervention | IV morphine mg equivalents (Mean) |
|---|
| 6 hours | 18 hours | 24 hours | 30 hours | 36 hours | 42 | 48 |
|---|
| N-acetylcysteine (NAC) | 12.0 | 19.9 | 24.7 | 27.2 | 29.7 | 33.1 | 34.9 |
,| Placebo | 14.6 | 25.0 | 29.6 | 34.0 | 37.9 | 40.9 | 43.3 |
Opioid Consumption 12 Hours Post Operative
Post operative opioid consumption in the 12 hours that occur post-operatively. (NCT04562597)
Timeframe: 12 hours
| Intervention | IV morphine mg equivalents (Mean) |
|---|
| Placebo | 19.4 |
| N-acetylcysteine (NAC) | 15.6 |