creatine and Idiopathic Parkinson Disease

creatine has been researched along with Idiopathic Parkinson Disease in 79 studies

Research

Studies (79)

Authors

Clinical Trials (4)

Trial Overview

Trial Outcomes

The Global Outcome Combined Information on Change From Baseline in Schwab England Activities of Daily Living, 39-Item Parkinson's Disease Questionnaire, Ambulatory Capacity, Symbol Digit Modalities, and Modified Rankin at 5 Years.

All outcomes were coded such that higher scores indicated worse outcomes. Patients were ranked on each outcome and their ranks were summed (summed-ranks). Higher summed ranks (range, 5-4775) indicate worse outcomes. The mean summed ranks were compared by treatment group by a global statistical test (GST). (NCT00449865)
Timeframe: Change from baseline to 5 YEARS

McMaster Gross Motor Function (GMFM 88)

The McMaster Gross Motor Function is a validated scale ranging from 0 to 100 (the higher the better). Since there was the possibility of a subject becoming totally disabled our FDA peer reviewed design called for its use as follows: If the subject completed both periods, the score was calculated as the difference in scores between the end of Period 2 (at 12 months) minus that at the end of Period 1 (6 months). If a subject became totally disabled, this difference was considered as plus infinity if it occurred in period 1 (Penalizes period 1), and minus infinity if it occurred in Period 2 (Penalizes period 2). The two treatments were compared via the Wilcoxon test, and the effect size was estimated using Kendall's Tau-B. This is interpreted in a similar manner to correlation with positive values favoring COQenzyme10 and negative values favoring placebo. One of the links in this report is to the the GMFM scale and how it is scored. A link to the instrument is included. (NCT00432744)
Timeframe: Taken at 6 and 12 Months

Non-parametric Hotelling T-square Bivariate Analysis of GMGF 88 and OPeds QOL.

This is a multivariate analysis of the first two outcomes: Period 2 minus Period 1 GMFM88 and Peds Quality of Life, analyzed as follows: First, to be in the analysis, subjects must contribute at least one of these endpoints. Second, if the subject became totally disabled during period 1, the difference was defined as + infinity, (highest possible evidence favoring period 2), and if the subject became totally disabled in period 2, the subject was scored as - infinity (highest possible evidence favoring period 1). Period 2 minus period 1 differences were ranked form low to high with missing values scores at the mid-rank. The Hotelling T-square was computed on these ranks and the P-value was obtained from 100,000 rerandomizations as the fraction of rerandomizations with T-sq at least as large as that observed. (NCT00432744)
Timeframe: end of 12 month minus end of 6 month difference.

Pediatric Quality of Life Scale

"The Pediatric Quality of Life Scale is a validated scale ranging from 0 to 100 (the higher the better). Since there was the possibility of a subject becoming totally disabled our FDA peer reviewed design called for its use as follows: If the subject completed both periods, the score was calculated as the difference in scores between the end of Period 2 (at 12 months) minus that at the end of Period 1 (6 months). If a subject became totally disabled, this difference was considered as plus infinity if it occurred in period 1 (Penalizes period 1), and minus infinity if it occurred in Period 2 (Penalizes period 2). The two treatments were compared via the Wilcoxon test, and the effect size was estimated using Kendall's Tau-B. This is interpreted in a similar manner to correlation with positive values favoring COQenzyme10 and negative values favoring placebo. Goggle pedsQL and Mapi to browse the copyrighted manual. A link to the instrument is included." (NCT00432744)
Timeframe: At 6 and 12 Months

Common Adverse Events: Back Pain

Musculoskeletal and Connective Tissue Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Common Adverse Events: Constipation

Gastrointestinal Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Common Adverse Events: Depression

Psychiatric Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Common Adverse Events: Diarrhoea

Gastrointestinal Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Common Adverse Events: Dizziness

Nervous system disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Common Adverse Events: Dyspepsia

Gastrointestinal Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Common Adverse Events: Fatigue

General Disorders and Administration Site Conditions. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Common Adverse Events: Headache

Nervous System disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Common Adverse Events: Hypotension

Vascular Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Common Adverse Events: Insomnia

Psychiatric Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Common Adverse Events: Nasopharyngitis

Infections and infestations. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Common Adverse Events: Nausea

Gastrointestinal Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Common Adverse Events: Oedema Peripheral

General disorders and administration site conditions. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Common Adverse Events: Sinusitis

Infections and Infestations. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Common Adverse Events: Somnolence

Nervous System Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Common Adverse Events: Upper Respiratory Tract Infection

Infections and Infestations. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Efficacy: Change in Activities of Daily Living(ADL) Subscale of the Unified Parkinson's Disease Rating Scale

The outcome is defined as change in ADL subscale of the Unified Parkinson's Disease Rating Scale(UPDRS Part II) between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. UPDRS Part II: Activities of Daily Living in the week prior to the designated visit, consisting of 13 questions answered on a 0-4 point scale where 0 represents the absence of impairment and 4 represents the highest degree of impairment. Total Part II score represents the sum of these 13 questions. A greater increase in score indicates a greater increase in disability. A total of 52 points are possible. 52 represents the worst (total) disability), 0--no disability (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Efficacy: Change in Beck Depression Inventory II (BDI-II)

The Beck Depression Inventory (BDI) is a validated self-reported 21-item depression scale that was tested and validated as a reliable instrument for screening for depression in PD. The outcome is defined as change in BDI-II between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. Total BDI score represents the sum of these 21-items. A higher change in score indicates a greater increase in disability. Total score of 0-13 is considered minimal, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Efficacy: Change in Mental Subscales of the Unified Parkinson's Disease Rating Scale

The outcome is defined as change in Mental subscale of Unified Parkinson's Disease Rating Scale(UPDRS Part I) between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. UPDRS Part I: Mentation, behavior and mood, consisting of 4 questions answered on a 0-4 point scale where 0 represents the absence of impairment and 4 represents the highest degree of impairment. Total score represents the sum of these 4 questions. A greater increase in score indicates a greater increase in disability. A total of 16 points are possible. 16 represents the worst (total) disability), 0--no disability. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Efficacy: Change in Modified Hoehn & Yahr Scale

The Modified Hoehn & Yahr Scale is an 8-level Parkinson's disease staging instrument. The outcome is defined as change in Modified Hoehn & Yahr Scale between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. A greater increase in stage indicates a greater increase in disability. Stage ranges from 0-5 (also including 1.5 and 2.5) with 0 indicating no disability and 5 indicating maximum disability. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Efficacy: Change in Modified Schwab & England Independence Scale

The Schwab & England scale is an investigator and subject assessment of the subject's level of independence at all scheduled study visits. The subject will be scored on a percentage scale reflective of his/her ability to perform acts of daily living in relation to what he/she did before Parkinson's disease appeared. The outcome is defined as change in Schwab & England Independence Scale between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. Higher decrease in score indicates higher disability. Score ranges from 100% (complete independence) to 0% (total disability). (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Efficacy: Change in Montreal Cognitive Assessment

The Montreal Cognitive Assessment(MoCA) is a brief 30-point screening instrument that was developed and validated to identify subjects with mild cognitive impairment. The outcome is defined as change in MoCA between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. Total MoCA score represents the sum of these 30-points, with a lower score indicating greater cognitive impairment. 30 is the maximum score, with a score of 26 or higher considered normal and below 26 indicative of Mild Cognitive Impairment. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Efficacy: Change in Motor Subscale of the Unified Parkinson's Disease Rating Scale

The outcome is defined as change in Motor subscale of the Unified Parkinson's Disease Rating Scale(UPDRS Part III) between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. UPDRS Part III: motor abilities at the time of the visit, consisting of 27 items (including 13 general questions and 14 sub-questions) each answered on a 0-4 point scale where 0 represents the absence of impairment and 4 represents the highest degree of impairment. Total Part III score represents the sum of these 27 items. A total of 108 points are possible. 108 represents the worst (total) disability), 0--no disability. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Efficacy: Change in Parkinson Disease Quality of Life Questionnaire-39(PDQ-39)

The PD Quality of Life Scale(PDQ-39) asks the subject to evaluate how Parkinson disease has affected their health and overall quality of life at that point in time. The total quality of life scale includes subscales relating to social role, self-image/sexuality, sleep, outlook, physical function and urinary function. The outcome is defined as change in PDQ-39 between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. It is scored on a scale of zero to 100, with lower scores indicating better health and higher scores more severe disability. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Efficacy: Change in Unified Parkinson's Disease Rating Scale (UPDRS)

Outcome is defined as change in total Unified Parkinson's Disease Rating Scale (UPDRS) between the baseline visit and month 12 or the time to require dopaminergic therapy (last visit before subject goes on dopaminergic therapy), whichever occurs first. The UPDRS score has 4 components. Part I assesses mentation; Part II assesses activities of daily living; Part III assesses motor abilities; Part IV assesses complications of therapy. A total of 44 items are included in Parts I-III. Each item will receive a score ranging from 0 to 4 where 0 represents the absence of impairment and 4 represents the highest degree of impairment. Part IV contains 11 items, 4 of these items are scored 0-4 in the same manner, and 7 are scored 0-1, with 0 indicating the absence of impairment and 1 indicating the presence of impairment. Total UPDRS score represents the sum of these items in Parts I-IV. A total of 199 points are possible. 199 represents the worst (total) disability), 0--no disability. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Tolerability of the Three Dosages(5mg, 10mg and 20mg) of Isradipine CR.

Tolerability will be judged by the proportion of subjects enrolled in a dosage group able to complete the 12 month study or to the time of initiation of dopaminergic therapy on their original assigned dosage. Tolerability of each active arm will be compared to placebo group. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Vital Signs: Change in Diastolic Standing

(NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Vital Signs: Change in Diastolic Supine

(NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Vital Signs: Change in Pulse Standing

(NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Vital Signs: Change in Pulse Supine

(NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Vital Signs: Change in Systolic Standing

(NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Vital Signs: Change in Systolic Supine

(NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Reviews

11 reviews available for creatine and Idiopathic Parkinson Disease

Trials

14 trials available for creatine and Idiopathic Parkinson Disease

Other Studies

54 other studies available for creatine and Idiopathic Parkinson Disease