Page last updated: 2024-10-25

clonidine and Neuralgia

clonidine has been researched along with Neuralgia in 46 studies

Clonidine: An imidazoline sympatholytic agent that stimulates ALPHA-2 ADRENERGIC RECEPTORS and central IMIDAZOLINE RECEPTORS. It is commonly used in the management of HYPERTENSION.
clonidine (amino form) : A clonidine that is 4,5-dihydro-1H-imidazol-2-amine in which one of the amino hydrogens is replaced by a 2,6-dichlorophenyl group.

Neuralgia: Intense or aching pain that occurs along the course or distribution of a peripheral or cranial nerve.

Research Excerpts

ExcerptRelevanceReference
"In a randomized, double-blind crossover study, 40 patients with postherpetic neuralgia were given single oral doses of clonidine, 0."9.06Association of pain relief with drug side effects in postherpetic neuralgia: a single-dose study of clonidine, codeine, ibuprofen, and placebo. ( Culnane, M; Dubner, R; Gracely, RH; Max, MB; Schafer, SC, 1988)
"We report a case of effective treatment with clonidine ointment for herpetic neuralgia in a child."7.71[A case of effective treatment with clonidine ointment for herpetic neuralgia after bone marrow transplantation in a child]. ( Arita, H; Hagihara, R; Hanaoka, K; Meno, A, 2002)
"Chronic pain is a major health issue and most patients suffer from spontaneous pain."5.42Huperzine A Alleviates Mechanical Allodynia but Not Spontaneous Pain via Muscarinic Acetylcholine Receptors in Mice. ( Feng, ZH; Li, XY; Liu, L; Mei, SH; Wang, M; Wang, Y; Wang, YJ; Zuo, ZX, 2015)
"Clonidine is a presynaptic alpha-2-adrenergic receptor agonist that has been used for many years to treat hypertension and other conditions, including chronic pain."5.22Topical clonidine for neuropathic pain in adults. ( Dobrogowski, J; Garlicki, J; Jakowicka-Wordliczek, J; Serednicki, WT; Wordliczek, J; Woron, J; Wrzosek, A; Zajaczkowska, R, 2022)
"In a randomized, double-blind crossover study, 40 patients with postherpetic neuralgia were given single oral doses of clonidine, 0."5.06Association of pain relief with drug side effects in postherpetic neuralgia: a single-dose study of clonidine, codeine, ibuprofen, and placebo. ( Culnane, M; Dubner, R; Gracely, RH; Max, MB; Schafer, SC, 1988)
"Clonidine is a presynaptic alpha-2-adrenergic receptor agonist used for many years to treat hypertension and other conditions, including chronic pain."4.91Topical clonidine for neuropathic pain. ( Dobrogowski, J; Jakowicka-Wordliczek, J; Wordliczek, J; Woron, J; Wrzosek, A, 2015)
"We report a case of effective treatment with clonidine ointment for herpetic neuralgia in a child."3.71[A case of effective treatment with clonidine ointment for herpetic neuralgia after bone marrow transplantation in a child]. ( Arita, H; Hagihara, R; Hanaoka, K; Meno, A, 2002)
"Thirty patients with type 2 diabetes with peripheral neuropathy as assessed by a visual analog scale (VAS) and divided into two groups of 15 patients, treated for up to three months."3.30Effectiveness of oral clonidine and gabapentin on peripheral neuropathy in diabetic patients in southwestern Iran: a randomized clinical trial. ( Ahmadi, SA; Bagheri, S; Dolatkhah, H; Hassanzadeh, S; Majid Ahmadi, S; Moradishibany, I; Reisi, S, 2023)
"First-line pharmacotherapy for neuropathic pain entails the use of systemic antidepressants and anticonvulsants."3.01The effect of a topical combination of clonidine and pentoxifylline on post-traumatic neuropathic pain patients: study protocol for a randomized, double-blind placebo-controlled trial. ( Coderre, TJ; Fulas, OA; Laferrière, A; Shir, Y; Ware, DMA, 2021)
"The frequency of neuropathic pain was assessed using the Douleur Neuropathique 4-question survey (DN4) in the first and second postoperative months."2.78Effect of the addition of clonidine to locally administered bupivacaine on acute and chronic postmastectomy pain. ( Abdel-Ghaffar, HS; Mohamed, SA, 2013)
"Eighty-five patients with severe cancer pain despite large doses of opioids or with therapy-limiting side effects from opioids were randomized to receive, in a double-blind manner, 30 micrograms/h epidural clonidine or placebo for 14 days, together with rescue epidural morphine."2.68Epidural clonidine analgesia for intractable cancer pain. The Epidural Clonidine Study Group. ( Allin, D; Dubois, M; DuPen, S; Eisenach, JC; Miguel, R, 1995)
"The use of topiceuticals in localized neuropathic pain associated with malignancy remain a valuable option with many advantages over systemic treatments."2.55The role of topiceuticals in cancer pain. ( Paisley, P; Serpell, M, 2017)
"Diagnosis of neuropathic pain is often easily made from information gathered on neurologic examination and from patient history."2.39Neuropathic pain of peripheral origin: advances in pharmacologic treatment. ( Galer, BS, 1995)
"Tizanidine was more effective in female than male neuropathic rats."1.72Sex-dependent antiallodynic effect of α ( Caram-Salas, NL; Castelo-Flores, DG; Centurión, D; De la Luz-Cuellar, YE; Granados-Soto, V; Rodríguez-Palma, EJ; Salinas-Abarca, AB, 2022)
"Occipital neuralgia is the third most common headache syndrome after migraine and tension type headaches."1.48Transcutaneous Electrical Nerve Stimulation in Treatment of Occipital Neuralgia: A Case Report. ( Candido, KD; Ghaly, RF; Knezevic, NN; Plesca, A, 2018)
"Our findings reveal that neuropathic pain-related cognitive impairments in male mice are correlated to bilateral morphological changes in PV interneurons and layer 5/6 IL pyramidal neuron AIS."1.48Neuropathic Pain Creates an Enduring Prefrontal Cortex Dysfunction Corrected by the Type II Diabetic Drug Metformin But Not by Gabapentin. ( Ahmad, A; Kroener, S; Mejia, G; Mwirigi, J; Pradhan, G; Price, T; Shiers, S, 2018)
"tizanidine is a highly selective α2-AR agonist, but the effect mechanism of tizanidine in neuropathic pain remains largely unknown."1.48Tizanidine exerts anti-nociceptive effects in spared nerve injury model of neuropathic pain through inhibition of TLR4/NF-κB pathway. ( Li, L; Pei, W; Wang, W; Wei, L; Zhao, Y; Zou, Y, 2018)
"Clonidine was intrathecally given after intraplantar injection of complete Freund's adjuvant (CFA) in mice."1.42Noradrenergic α2 receptor attenuated inflammatory pain through STEP61/ERK signalling. ( Hu, XD; Suo, ZW; Wang, XT; Xu, YM; Yang, X; Zhang, ZY, 2015)
"Resiniferatoxin (RTX) is an ultrapotent synthetic TRPV1 (transient receptor potential vanilloid subtype 1) agonist with significant initial transient hyperalgesia followed by a prolonged analgesic effect in response to thermal stimulus."1.42The effect of clonidine pretreatment on epidural resiniferatoxin in a neuropathic pain rat model. ( Choi, SS; Choi, YS; Huh, BK; Hur, WS; Kim, HS; Kim, HZ; Lee, DK; Lee, MG; Lee, MK; Lim, BG, 2015)
"Chronic pain is a major health issue and most patients suffer from spontaneous pain."1.42Huperzine A Alleviates Mechanical Allodynia but Not Spontaneous Pain via Muscarinic Acetylcholine Receptors in Mice. ( Feng, ZH; Li, XY; Liu, L; Mei, SH; Wang, M; Wang, Y; Wang, YJ; Zuo, ZX, 2015)
"Neuropathic pain is not accompanied by modifications in tonic LC activity after the onset of pain."1.38The function of alpha-2-adrenoceptors in the rat locus coeruleus is preserved in the chronic constriction injury model of neuropathic pain. ( Alba-Delgado, C; Berrocoso, E; Borges, G; Horrillo, I; Meana, JJ; Mico, JA; Neto, F; Ortega, JE; Sánchez-Blázquez, P, 2012)
"Many drugs approved for neuropathic pain engage spinal noradrenergic and cholinergic systems for analgesia."1.37A tropomyosine receptor kinase inhibitor blocks spinal neuroplasticity essential for the anti-hypersensitivity effects of gabapentin and clonidine in rats with peripheral nerve injury. ( Eisenach, JC; Hayashida, K, 2011)
"Neuropathic pain is often "spontaneous" or "stimulus-independent."1.37Lesion of the rostral anterior cingulate cortex eliminates the aversiveness of spontaneous neuropathic pain following partial or complete axotomy. ( Fields, HL; King, T; Lai, J; Okun, A; Porreca, F; Qu, C, 2011)
"Gabapentin and clonidine were concomitantly administered in a fixed-dose ratio proportional to the predetermined ED(50) of these drugs, thereby obtaining a dose-response curve for the drug combination and its ED(50)."1.36Intrathecal gabapentin and clonidine synergistically inhibit allodynia in spinal nerve-ligated rats. ( Asada, A; Funao, T; Mori, T; Nishikawa, K; Yamama, Y, 2010)
"Many treatments for neuropathic pain activate or augment norepinephrine release in the spinal cord, yet these treatments are less effective against acute nociceptive stimuli."1.35Brain derived nerve growth factor induces spinal noradrenergic fiber sprouting and enhances clonidine analgesia following nerve injury in rats. ( Clayton, BA; Eisenach, JC; Hayashida, KI; Johnson, JE, 2008)
"Neuropathic pain is associated with several sensory abnormalities, including allodynia as well as spontaneous pain."1.34Opioid self-administration in the nerve-injured rat: relevance of antiallodynic effects to drug consumption and effects of intrathecal analgesics. ( Buechler, NL; Eisenach, JC; Kim, SA; Martin, TJ; Porreca, F, 2007)
"morphine and baclofen were superior to clonidine and R-PIA."1.31Effects of intrathecal morphine, baclofen, clonidine and R-PIA on the acute allodynia-like behaviours after spinal cord ischaemia in rats. ( Hao, JX; Sollevi, A; von Heijne, M; Xu, XJ, 2001)
"Tizanidine was effective in reducing sensitivity to heat, as measured by paw withdrawal latency, and did not cause sedation at smaller doses."1.31Systemic tizanidine hydrochloride (Zanaflex) relieves thermal hyperalgesia in rats with an experimental mononeuropathy. ( Azevedo, MI; Chalfoun, AG; Denson, DD; Hord, AH, 2001)

Research

Studies (46)

TimeframeStudies, this research(%)All Research%
pre-19902 (4.35)18.7374
1990's6 (13.04)18.2507
2000's14 (30.43)29.6817
2010's18 (39.13)24.3611
2020's6 (13.04)2.80

Authors

AuthorsStudies
Rodríguez-Palma, EJ1
Castelo-Flores, DG1
Caram-Salas, NL1
Salinas-Abarca, AB1
Centurión, D1
De la Luz-Cuellar, YE1
Granados-Soto, V1
Serednicki, WT1
Wrzosek, A2
Woron, J2
Garlicki, J1
Dobrogowski, J2
Jakowicka-Wordliczek, J2
Wordliczek, J2
Zajaczkowska, R1
Hassanzadeh, S1
Bagheri, S1
Majid Ahmadi, S1
Ahmadi, SA1
Moradishibany, I1
Dolatkhah, H1
Reisi, S1
Sanna, MD1
Borgonetti, V1
Masini, E1
Galeotti, N1
Yoon, SY2
Roh, DH2
Yeo, JH1
Woo, J1
Han, SH1
Kim, KS1
Fulas, OA1
Laferrière, A1
Ware, DMA1
Shir, Y1
Coderre, TJ1
Paisley, P1
Serpell, M1
Ghaly, RF1
Plesca, A1
Candido, KD1
Knezevic, NN1
Patel, R1
Qu, C2
Xie, JY1
Porreca, F4
Dickenson, AH1
Shiers, S1
Pradhan, G1
Mwirigi, J1
Mejia, G1
Ahmad, A1
Kroener, S1
Price, T1
Pei, W1
Zou, Y1
Wang, W1
Wei, L1
Zhao, Y1
Li, L1
Suter, MR1
Sprenger, T1
Taub, E1
Besson, M1
Xu, YM1
Wang, XT1
Zhang, ZY1
Suo, ZW1
Yang, X1
Hu, XD1
Lee, MG1
Lee, DK1
Huh, BK1
Choi, SS1
Kim, HZ1
Lim, BG1
Kim, HS1
Choi, YS1
Hur, WS1
Lee, MK1
Zuo, ZX1
Wang, YJ1
Liu, L1
Wang, Y1
Mei, SH1
Feng, ZH1
Wang, M1
Li, XY1
Zhang, L1
Wang, G1
Ma, J1
Liu, C1
Liu, X1
Zhan, Y1
Zhang, M1
Taira, T1
Kim, HW1
Seo, HS1
Kwon, YB1
Han, HJ1
Beitz, AJ1
Lee, JH1
King, T2
Vera-Portocarrero, L1
Gutierrez, T1
Vanderah, TW1
Dussor, G1
Lai, J2
Fields, HL2
Hayashida, K2
Eisenach, JC5
Yamama, Y1
Nishikawa, K1
Funao, T1
Mori, T1
Asada, A1
Okun, A1
Alba-Delgado, C1
Borges, G1
Sánchez-Blázquez, P1
Ortega, JE1
Horrillo, I1
Mico, JA1
Meana, JJ1
Neto, F1
Berrocoso, E1
Xing, YH1
Leng, YF1
Wang, SX1
Gao, XM1
Wei, H1
Viisanen, H1
Amorim, D1
Koivisto, A1
Pertovaara, A1
Mohamed, SA1
Abdel-Ghaffar, HS1
Hagihara, R1
Meno, A2
Arita, H2
Hanaoka, K2
Rodrigues-Filho, R1
Campos, MM1
Ferreira, J1
Santos, AR1
Bertelli, JA1
Calixto, JB1
Naja, MZ1
Al-Tannir, MA1
Maaliki, H1
El-Rajab, M1
Ziade, MF1
Zeidan, A1
Martin, TJ2
Kim, SA2
Buechler, NL1
He, ZH1
Guo, QL1
Zou, WY1
Huang, CS1
Hayashida, KI1
Clayton, BA1
Johnson, JE1
Obata, H1
DuPen, S1
Dubois, M1
Miguel, R1
Allin, D1
Galer, BS1
Abadir, AR1
Kraynack, BJ1
Mayda, J1
Gintautas, J1
Jevtovic-Todorovic, V1
Wozniak, DF1
Powell, S1
Nardi, A1
Olney, JW1
Bonezzi, C1
Demartini, L1
von Heijne, M1
Hao, JX1
Sollevi, A1
Xu, XJ1
Hord, AH1
Chalfoun, AG1
Denson, DD1
Azevedo, MI1
Barolin, GS1
Kirkpatrick, AF1
Derasari, M1
Glodek, JA1
Piazza, PA1
Max, MB1
Schafer, SC1
Culnane, M1
Dubner, R1
Gracely, RH1

Clinical Trials (8)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Multicenter, Randomized, Double-Blind, Parallel-Group Study Comparing the Efficacy and Safety of Clonidine Topical Gel, 0.1% With Placebo in the Management of Pain Associated With Painful Diabetic Neuropathy[NCT00695565]Phase 2180 participants (Actual)Interventional2008-05-31Completed
A Multicenter Randomized, Double-Blind, Placebo-Controlled, 2-Arm Parallel-Group Study to Determine the Efficacy and Safety of Clonidine Hydrochloride Topical Gel, 0.1% in the Treatment of Pain Associated With Painful Diabetic Neuropathy[NCT02068027]Phase 2260 participants (Actual)Interventional2014-03-31Completed
Diabetic Neuropathic Pain Topical Treatment- Comparative Study[NCT00661063]Phase 3200 participants (Anticipated)Interventional2008-04-30Not yet recruiting
The Effects of Topical Treatment With Clonidine + Pentoxifylline in Patients With Neuropathic Pain[NCT03342950]Phase 24 participants (Actual)Interventional2019-02-19Terminated (stopped due to Low recruitment due to the COVID-19 pandemic)
Effect of Metformin on Chronic Pain After Thoracic Surgery in Diabetic Patients[NCT04089813]200 participants (Anticipated)Observational2019-09-10Not yet recruiting
Hemodynamic Effect of Intrathecal Clonidine in Hypertensive Subjects: A Pilot Study to Assess Its Effectiveness in Hypertensive Subjects With Poor Blood Pressure Control (Phase II)[NCT01297335]Phase 210 participants (Actual)Interventional2011-02-28Completed
Early Detection of Taxane-Induced Neuropathy in Women With Breast Cancer[NCT02549534]29 participants (Actual)Observational2015-09-30Completed
A Safe Ketamine-Based Therapy for Treatment Resistant Depression[NCT01179009]20 participants (Actual)Interventional2012-04-30Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Change From Baseline in the Brief Pain Inventory (BPI) Severity Scale at Week 12; mLOCF Imputation

"The Brief Pain Inventory was completed by the subject at clinic visits. The Severity Scale (of 0 to 40) is a composite score, which is the sum of the individual ratings for worst pain, least pain, average pain, and current pain. Each individual question is rated on a scale of 0 to 10, where 0 indicates No Pain and 10 indicates Pain as bad as you can imagine. The change in pain severity is represented as Week 12 minus Baseline, so greater negative numbers represent greater improvement (pain relief)." (NCT00695565)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Mean)
Placebo Gel-7.9
Clonidine Topical Gel (ARC-4558)-9.6

Change From Baseline in the Brief Pain Inventory Functional Interference Scale at Week 12; mLOCF Imputation

"The Brief Pain Inventory was completed by the subject at clinic visits. The Functional Interference Scale (of 0 to 70) is a composite score that measures the degree to which pain interferes with mood, walking, work, relationships, sleep, general activity, and enjoyment of life. The composite score is a sum of the seven individual question scores. Each individual question is rated in reference to pain over the past 24 hours on a scale of 0 to 10, where 0 indicates that pain does not interfere and 10 indicates that pain completely interferes with that function, so lower scores represent better outcomes on this scale.~The change in functional interference is represented as Week 12 minus Baseline, so greater negative numbers represent more improvement." (NCT00695565)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Mean)
Placebo Gel-15.1
Clonidine Topical Gel (ARC-4558)-17.3

Change From Baseline to Week 12 in Overall Quality of Sleep (Chronic Pain Sleep Inventory)

Subjects rated overall quality of sleep over the past week using a 100 mm Visual Analog Scale (VAS) where 100=Excellent and 0=Very Poor. This scale was completed during clinic visits. Change from Baseline is a positive value where quality of sleep improved. (NCT00695565)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Mean)
Placebo Gel17.7
Clonidine Topical Gel (ARC-4558)19.2

Change From Baseline to Week 12 in the Anxiety Score of the Hospital Anxiety and Depression Scale (HADS)

The HADS was completed at the Baseline and Week 12 clinic visits. The Anxiety Score component of the HADS includes 7 questions, each with 4 possible answer choices (rated 0 to 3). The composite score is created by adding the scores of the 7 individual questions. A score of 0 to 7 is Normal, 8-10 indicates Mild Anxiety, 11-14 indicates Moderate Anxiety, and 15-21 indicates Severe Anxiety. The change from Baseline is calculated as the Week 12 composite score minus the Baseline composite score. (NCT00695565)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Mean)
Placebo Gel-0.6
Clonidine Topical Gel (ARC-4558)-1.1

Change From Baseline to Week 12 in the Depression Score of the Hospital Anxiety and Depression Scale (HADS)

The HADS was completed at the Baseline and Week 12 clinic visits. The Depression Score component of the HADS includes 7 questions, each with 4 possible answer choices (rated 0 to 3). The composite score is created by adding the scores of the 7 individual questions. A score of 0 to 7 is Normal, 8-10 indicates Mild Depression, 11-14 indicates Moderate Depression, and 15-21 indicates Severe Depression. The change from Baseline is calculated as the Week 12 composite score minus the Baseline composite score. (NCT00695565)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Mean)
Placebo Gel-0.4
Clonidine Topical Gel (ARC-4558)-0.9

Change From Baseline to Week 12 in the McGill Pain Questionnaire (Short Form) Total Score

The McGill Pain Questionnaire asks subjects to rate 15 different kinds of pain, each on a scale of 0 to 3 (0=None, 1=Mild, 2=Moderate, 3=Severe). The total score is a sum of the individual ratings and has a range from 0 to 45, where higher numbers indicate more pain. The 15 types of pain assessed are throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, splitting, tiring-exhausting, sickening, fearful, and punishing-cruel. This scale was completed at the Baseline and Week 12 clinic visits. The change from Baseline is calculated as the Week 12 total score minus the Baseline total score, so greater negative numbers indicate more improvement (pain relief). (NCT00695565)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Mean)
Placebo Gel-7.3
Clonidine Topical Gel (ARC-4558)-8.7

Change From Baseline to Week 12 in the Worst Daily Pain NPRS Score; mLOCF Imputation

"Pain in the feet was scored daily at bedtime by the subject on a 0-10 numeric pain rating scale. Subjects were asked to record the worst pain in their feet over the past 24 hours. A score of 0 indicated no pain and a score of 10 was worst possible pain. The change in pain is represented as Week 12 minus Baseline, so greater negative numbers represent greater improvement (greater pain relief)." (NCT00695565)
Timeframe: Baseline (average of Days -7 to -1) and Week 12 (average of Days 78 to 84)

Interventionunits on a scale (Mean)
Placebo Gel-2.1
Clonidine Topical Gel (ARC-4558)-2.5

Percentage of Subjects Who Experience at Least 30% Reduction in Average Daily Pain From Baseline; mLOCF Imputation

"Pain in the feet was scored daily at bedtime by the subject on a 0-10 numeric pain rating scale (NPRS). Subjects were asked to record average pain in the feet over the past 24 hours. A score of 0 indicated no pain and a score of 10 was worst possible pain." (NCT00695565)
Timeframe: Baseline (average of Days -7 to -1) and Week 12 (average of Days 78 to 84)

Interventionpercentage of subjects (Number)
Placebo Gel47
Clonidine Topical Gel (ARC-4558)52

Percentage of Subjects Who Experience at Least 50% Reduction in Average Daily Pain From Baseline; mLOCF Imputation

"Pain in the feet was scored daily at bedtime by the subject on a 0-10 numeric pain rating scale (NPRS). Subjects were asked to record average pain in the feet over the past 24 hours. A score of 0 indicated no pain and a score of 10 was worst possible pain." (NCT00695565)
Timeframe: Baseline (average of Days -7 to -1) and Week 12 (average of Days 78 to 84)

Interventionpercentage of subjects (Number)
Placebo Gel32
Clonidine Topical Gel (ARC-4558)37

Change From Baseline in Average Daily Pain NPRS Score for Each Week of Treatment; mLOCF Imputation

"Pain in the feet was scored daily at bedtime by the subject on a 0-10 numeric pain rating scale (NPRS). Subjects were asked to record average pain in the feet over the past 24 hours. A score of 0 indicated no pain and a score of 10 was worst possible pain. A weekly average was calculated from the daily scores for each week. The change in pain is represented as the average weekly score minus Baseline, so greater negative numbers represent more improvement (more pain relief)." (NCT00695565)
Timeframe: Baseline (average of Days -7 to -1) and Weeks 1 through 12 (weekly averages)

,
Interventionunits on a scale (Mean)
Week 1Week 2Week 3Week 4Week 5Week 6Week 7Week 8Week 9Week 10Week 11Week 12
Clonidine Topical Gel (ARC-4558)-0.7-1.0-1.5-1.6-1.7-1.8-2.1-2.2-2.3-2.4-2.3-2.4
Placebo Gel-0.6-1.0-1.2-1.5-1.7-1.8-1.8-1.9-1.9-1.9-1.9-1.9

Change From Baseline to Week 12 in the Average Daily Pain NPRS (Numeric Pain Rating Scale) Score; mLOCF Imputation

"Pain in the feet was scored daily at bedtime by the subject on a 0-10 numeric pain rating scale (NPRS) through Day 84. Subjects were asked to record average pain in the feet over the past 24 hours. A score of 0 indicated no pain and a score of 10 was worst possible pain.~The change in pain is represented as Week 12 minus Baseline, so greater negative numbers represent more improvement (more pain relief)." (NCT00695565)
Timeframe: Baseline (average of Days -7 to -1) and Week 12 (Average of Days 78 to 84)

,
Interventionunits on a scale (Mean)
All subjectsCapsaicin response ≥ 2
Clonidine Topical Gel (ARC-4558)-2.4-2.7
Placebo Gel-1.9-1.5

Change in Blood Pressure From Baseline to Week 12

Systolic and Diastolic Blood Pressure were measured at clinic visits. This outcome assesses the change in blood pressure from Baseline to Week 12 of treatment. (NCT00695565)
Timeframe: Baseline and Week 12

,
InterventionmmHg (Mean)
Change in Systolic BPChange in Diastolic BP
Clonidine Topical Gel (ARC-4558)1.01.0
Placebo Gel-0.4-0.2

Clinician Global Impression of Change (CGIC) at Week 12

At Week 12, the Investigator was asked to independently rate the subject's total improvement relative to Baseline, whether or not, in their judgement, it was due entirely to study drug treatment or not. Answer choices were: (+3) very much improved, (+2) much improved, (+1) minimally improved, (0) no change, (-1) minimally worse, (-2) much worse, (-3) very much worse. (NCT00695565)
Timeframe: Week 12

,
Interventionpercentage of subjects (Number)
Very Much ImprovedMuch ImprovedMinimally ImprovedNo ChangeMinimally WorseVery Much Worse
Clonidine Topical Gel (ARC-4558)16.530.624.727.11.20
Placebo Gel5.838.427.925.62.30

Patient Global Impression of Change (PGIC) at Week 12

At Week 12 the subject was asked to rate their total improvement relative to Baseline, whether or not, in their judgement, it was due entirely to study drug treatment or not. Answer choices were: (+3) very much improved, (+2) much improved, (+1) minimally improved, (0) no change, (-1) minimally worse, (-2) much worse, (-3) very much worse. (NCT00695565)
Timeframe: Week 12

,
Interventionpercentage of subjects (Number)
Very Much ImprovedMuch ImprovedMinimally ImprovedNo ChangeMinimally WorseVery Much Worse
Clonidine Topical Gel (ARC-4558)21.227.128.222.41.20
Placebo Gel11.832.931.821.21.21.2

Change From Baseline to Day 84 (Week 12) in Numeric Pain Rating Scale Score

"The Numeric Pain Rating Scale is a single reading that measures the patients interpretation of their pain on a scale from 0, no pain to 10, worst pain imaginable. The change from baseline can range from -10 to 10. The change from Baseline (averaged over Day -14 to Day -8) to End-of-Treatment (averaged over Days 78 to 84 [±3 days]) in the Numeric Pain Rating Scale score assessing the average pain in the past 24 hours in the painful areas of the feet averaged over Days 78 to 84 compared to the 7 days at the Baseline Phase (Days -14 to -8). For the primary efficacy endpoint, the mean change in pain intensity from Baseline to Week 12 was analyzed using an analysis of covariance (ANCOVA) model with the Baseline pain intensity score serving as a covariate. The statistical model also included treatment, site, site by treatment interaction, and strata. If the site by treatment interaction term was not significant at the 0.1 level, then it was excluded from the model." (NCT02068027)
Timeframe: The change from Baseline (averaged over Day -14 to Day -8) to End-of-Treatment (averaged over Days 78 to 84 [±3 days])

Interventionunits on a scale (Mean)
Clonidine Gel 0.1%-1.6
Placebo-1.6

Mean Daily Worst Pain Intensity Numeric Pain Rating Scale Scores

"The Numeric Pain Rating Scale is a single reading that measures the patients interpretation of their pain on a scale from 0, no pain to 10, worst pain imaginable. The change from baseline can range from -10 to 10. The change from Baseline (worst score from Day -14 to Day -8) to End-of-Treatment (worst score during Days 78 to 84 [±3 days]) in the Numeric Pain Rating Scale score assessing the worst pain in the past 24 hours in the painful areas of the feet from Days 78 to 84 compared to the 7 days at the Baseline Phase (Days -14 to -8). For the endpoint, the change in worst pain intensity from Baseline to Week 12 was analyzed using an analysis of covariance (ANCOVA) model with the Baseline worst pain intensity score serving as a covariate. The statistical model also included treatment, site, site by treatment interaction, and strata. If the site by treatment interaction term was not significant at the 0.1 level, then it was excluded from the model." (NCT02068027)
Timeframe: The change from Baseline (worse over Day -14 to Day -8) to End-of-Treatment (worse over Days 78 to 84 [±3 days])

Interventionunits on a scale (Mean)
Clonidine Gel 0.1%-1.4
Placebo-1.4

Change in Blood Pressure After Intrathecal Injection of Clonidine.

"Subjects baseline blood pressure (systolic blood pressure (SBP), and diastolic blood pressure (DBP)), and blood pressures after clonidine injection was compared against baseline to assess efficacy of clonidine in refractory hypertensive subjects. Subject's blood pressure was monitored continuously after intrathecal injection of clonidine until subjects blood pressure nadir and return to pre clonidine injection level. The mean value reported below are the average changes in blood pressure from baseline (pre clonidine injection) in both SBP and DBP during post clonidine injection blood pressure monitoring for 4 hours.~Blood pressure measurements were collected every 10 minutes for first hour after injection, and every 15 minutes after the first hour, up to 4 hours were averaged to report the change from baseline." (NCT01297335)
Timeframe: Baseline, Every 10 Minutes for first hour after clonidine injection, and every 15 minutes after first hour, until 4 hours after clonidine injection

Interventionmm Hg (Mean)
Change in mean SBP after clonidine injectionChange in DBP after clonidine injection
Intrathecal Clonidine7937

Changes in Visual Analogue Scale (VAS) Ratings of Sedation and Sensation of Dry Mouth Reported by the Subjects, Pre and 1 Hour Post Injection

Subjects were asked to rate severity of two of the most common side effects of clonidine, sedation and sensation of dry mouth, at pre and post (1 hour after) intrathecal administration of clonidine. The mean changes between pre and post injection VAS ratings of sedation and sensation of dry mouth are reported below. The VAS scale ranges from 1 to 10 cm, with higher values indicating higher level of sedation and higher level of dry mouth. (NCT01297335)
Timeframe: Before clonidine injection (Baseline), and at 1 hour after clonidine injection.

Interventioncm (Mean)
Change in level of sedationChange in sensation of dry mouth
Intrathecal Clonidine3.363.47

Likert Scale Pain Rating

Likert scale is 11 point digital pain rating system that asks subjects to rate their pain from 0 to 10. Rating of 0 means no pain at all, and in increasing order, 10 would mean worst pain imaginable/ unbearable pain. (NCT01297335)
Timeframe: Pre-dose and 1 hour post injection.

Interventionunits on a scale (Mean)
Pre-injection average Likert scorePost-injection average Likert score
Intrathecal Clonidine6.53.6

Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item scale that measures the severity of depression, with a higher score indicating a higher level of depression. The range of scores is 0 to 60. (NCT01179009)
Timeframe: 8 weeks

InterventionScores on a scale (Mean)
Ketamine 100-hour Infusion-9.0
Ketamine 40-minute Infusion-6.4

Reviews

8 reviews available for clonidine and Neuralgia

ArticleYear
Topical clonidine for neuropathic pain in adults.
    The Cochrane database of systematic reviews, 2022, 05-19, Volume: 5

    Topics: Adult; Analgesics; Chronic Pain; Clonidine; Diabetic Neuropathies; Humans; Neuralgia; Randomized Con

2022
Topical clonidine for neuropathic pain in adults.
    The Cochrane database of systematic reviews, 2022, 05-19, Volume: 5

    Topics: Adult; Analgesics; Chronic Pain; Clonidine; Diabetic Neuropathies; Humans; Neuralgia; Randomized Con

2022
Topical clonidine for neuropathic pain in adults.
    The Cochrane database of systematic reviews, 2022, 05-19, Volume: 5

    Topics: Adult; Analgesics; Chronic Pain; Clonidine; Diabetic Neuropathies; Humans; Neuralgia; Randomized Con

2022
Topical clonidine for neuropathic pain in adults.
    The Cochrane database of systematic reviews, 2022, 05-19, Volume: 5

    Topics: Adult; Analgesics; Chronic Pain; Clonidine; Diabetic Neuropathies; Humans; Neuralgia; Randomized Con

2022
Topical clonidine for neuropathic pain in adults.
    The Cochrane database of systematic reviews, 2022, 05-19, Volume: 5

    Topics: Adult; Analgesics; Chronic Pain; Clonidine; Diabetic Neuropathies; Humans; Neuralgia; Randomized Con

2022
Topical clonidine for neuropathic pain in adults.
    The Cochrane database of systematic reviews, 2022, 05-19, Volume: 5

    Topics: Adult; Analgesics; Chronic Pain; Clonidine; Diabetic Neuropathies; Humans; Neuralgia; Randomized Con

2022
Topical clonidine for neuropathic pain in adults.
    The Cochrane database of systematic reviews, 2022, 05-19, Volume: 5

    Topics: Adult; Analgesics; Chronic Pain; Clonidine; Diabetic Neuropathies; Humans; Neuralgia; Randomized Con

2022
Topical clonidine for neuropathic pain in adults.
    The Cochrane database of systematic reviews, 2022, 05-19, Volume: 5

    Topics: Adult; Analgesics; Chronic Pain; Clonidine; Diabetic Neuropathies; Humans; Neuralgia; Randomized Con

2022
Topical clonidine for neuropathic pain in adults.
    The Cochrane database of systematic reviews, 2022, 05-19, Volume: 5

    Topics: Adult; Analgesics; Chronic Pain; Clonidine; Diabetic Neuropathies; Humans; Neuralgia; Randomized Con

2022
The role of topiceuticals in cancer pain.
    Current opinion in supportive and palliative care, 2017, Volume: 11, Issue:2

    Topics: Administration, Cutaneous; Analgesics, Opioid; Anesthetics, Local; Cancer Pain; Capsaicin; Clinical

2017
[New concepts in the pathophysiology, diagnosis and treatment of neuropathic pain].
    Revue medicale suisse, 2013, Jun-26, Volume: 9, Issue:392

    Topics: Analgesics; Capsaicin; Clonidine; Diabetic Neuropathies; Headache; Humans; Neuralgia; Pain Measureme

2013
Topical clonidine for neuropathic pain.
    The Cochrane database of systematic reviews, 2015, Aug-31, Volume: 8

    Topics: Administration, Topical; Adrenergic alpha-2 Receptor Agonists; Analgesics; Chronic Pain; Clonidine;

2015
[Chronic intrathecal drug administration for the control of intractable pain].
    Brain and nerve = Shinkei kenkyu no shinpo, 2008, Volume: 60, Issue:5

    Topics: Amines; Analgesics, Opioid; Anesthetics, Local; Baclofen; Calcium Channel Blockers; Clonidine; Cyclo

2008
[Alpha2-adrenergic receptors in the dorsal horn of the spinal cord--their function and the descending inhibitory systems].
    Masui. The Japanese journal of anesthesiology, 2007, Volume: 56 Suppl

    Topics: Acetylcholine; Adrenergic alpha-2 Receptor Agonists; Amines; Analgesics; Animals; Brain-Derived Neur

2007
Neuropathic pain of peripheral origin: advances in pharmacologic treatment.
    Neurology, 1995, Volume: 45, Issue:12 Suppl 9

    Topics: Adrenergic alpha-Agonists; Analgesics, Opioid; Anesthetics, Local; Animals; Anti-Arrhythmia Agents;

1995
Treatment options in postherpetic neuralgia.
    Acta neurologica Scandinavica. Supplementum, 1999, Volume: 173

    Topics: Analgesics; Analgesics, Opioid; Anticonvulsants; Antidepressive Agents, Tricyclic; Clinical Trials a

1999

Trials

7 trials available for clonidine and Neuralgia

ArticleYear
Effectiveness of oral clonidine and gabapentin on peripheral neuropathy in diabetic patients in southwestern Iran: a randomized clinical trial.
    BMC endocrine disorders, 2023, Oct-16, Volume: 23, Issue:1

    Topics: Amines; Analgesics; Clonidine; Cyclohexanecarboxylic Acids; Diabetes Mellitus, Type 2; Diabetic Neur

2023
The effect of a topical combination of clonidine and pentoxifylline on post-traumatic neuropathic pain patients: study protocol for a randomized, double-blind placebo-controlled trial.
    Trials, 2021, Feb-17, Volume: 22, Issue:1

    Topics: Analgesics; Clonidine; Double-Blind Method; Humans; Neuralgia; Pain Measurement; Pentoxifylline; Ran

2021
Effect of the addition of clonidine to locally administered bupivacaine on acute and chronic postmastectomy pain.
    Journal of clinical anesthesia, 2013, Volume: 25, Issue:1

    Topics: Acute Pain; Administration, Topical; Adult; Analgesics; Anesthetics, Local; Breast Neoplasms; Bupiva

2013
Epidural clonidine analgesia for intractable cancer pain. The Epidural Clonidine Study Group.
    Pain, 1995, Volume: 61, Issue:3

    Topics: Adult; Aged; Aged, 80 and over; Analgesia, Epidural; Analgesics, Opioid; Analysis of Variance; Cloni

1995
Postherpetic neuralgia: response to topical clonidine.
    Proceedings of the Western Pharmacology Society, 1996, Volume: 39

    Topics: Administration, Cutaneous; Adrenergic alpha-Agonists; Aged; Aged, 80 and over; Clonidine; Female; He

1996
[Preliminary report: the efficacy of clonidine hydrochloride ointment for postherpetic neuralgia].
    Masui. The Japanese journal of anesthesiology, 2001, Volume: 50, Issue:2

    Topics: Administration, Topical; Aged; Clonidine; Female; Herpes Zoster; Humans; Male; Middle Aged; Neuralgi

2001
Association of pain relief with drug side effects in postherpetic neuralgia: a single-dose study of clonidine, codeine, ibuprofen, and placebo.
    Clinical pharmacology and therapeutics, 1988, Volume: 43, Issue:4

    Topics: Aged; Aged, 80 and over; Clinical Trials as Topic; Clonidine; Codeine; Double-Blind Method; Female;

1988

Other Studies

31 other studies available for clonidine and Neuralgia

ArticleYear
Sex-dependent antiallodynic effect of α
    European journal of pharmacology, 2022, Apr-05, Volume: 920

    Topics: Adrenergic alpha-2 Receptor Agonists; Animals; Clonidine; Female; Hyperalgesia; Male; Neuralgia; Rat

2022
Histamine H
    European journal of pharmacology, 2020, Feb-05, Volume: 868

    Topics: Adrenergic alpha-2 Receptor Agonists; Adrenergic Neurons; Animals; Benzimidazoles; Clonidine; Diseas

2020
Analgesic Efficacy of α
    Neuroscience, 2021, 02-10, Volume: 455

    Topics: Adrenergic Agonists; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Analgesics; An

2021
Transcutaneous Electrical Nerve Stimulation in Treatment of Occipital Neuralgia: A Case Report.
    A&A practice, 2018, Jul-01, Volume: 11, Issue:1

    Topics: Adult; Analgesics; Clonidine; Female; Headache Disorders; Humans; Neck Pain; Neuralgia; Occipital Lo

2018
Selective deficiencies in descending inhibitory modulation in neuropathic rats: implications for enhancing noradrenergic tone.
    Pain, 2018, Volume: 159, Issue:9

    Topics: Action Potentials; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-2 Receptor Antagonists; Ad

2018
Neuropathic Pain Creates an Enduring Prefrontal Cortex Dysfunction Corrected by the Type II Diabetic Drug Metformin But Not by Gabapentin.
    The Journal of neuroscience : the official journal of the Society for Neuroscience, 2018, 08-15, Volume: 38, Issue:33

    Topics: Analgesics; Animals; Attention; Axons; Clonidine; Cognition Disorders; Discrimination, Psychological

2018
Tizanidine exerts anti-nociceptive effects in spared nerve injury model of neuropathic pain through inhibition of TLR4/NF-κB pathway.
    International journal of molecular medicine, 2018, Volume: 42, Issue:6

    Topics: Analgesics; Animals; Clonidine; Interleukin-1beta; Interleukin-6; Male; Neuralgia; NF-kappa B; Rats;

2018
Noradrenergic α2 receptor attenuated inflammatory pain through STEP61/ERK signalling.
    European journal of pain (London, England), 2015, Volume: 19, Issue:9

    Topics: Adrenergic alpha-2 Receptor Agonists; Animals; Clonidine; Disease Models, Animal; Male; MAP Kinase S

2015
The effect of clonidine pretreatment on epidural resiniferatoxin in a neuropathic pain rat model.
    Acta medica Okayama, 2015, Volume: 69, Issue:2

    Topics: Analgesia, Epidural; Analgesics; Animals; Clonidine; Diterpenes; Hyperalgesia; Injections, Epidural;

2015
Huperzine A Alleviates Mechanical Allodynia but Not Spontaneous Pain via Muscarinic Acetylcholine Receptors in Mice.
    Neural plasticity, 2015, Volume: 2015

    Topics: Acetylcholinesterase; Alkaloids; Ambenonium Chloride; Analgesics; Animals; Atropine; Behavior, Anima

2015
Brain-derived neurotrophic factor (BDNF) in the rostral anterior cingulate cortex (rACC) contributes to neuropathic spontaneous pain-related aversion via NR2B receptors.
    Brain research bulletin, 2016, Volume: 127

    Topics: Analgesics; Animals; Avoidance Learning; Brain-Derived Neurotrophic Factor; Clonidine; Conditioning,

2016
Intrathecal clonidine suppresses phosphorylation of the N-methyl-D-aspartate receptor NR1 subunit in spinal dorsal horn neurons of rats with neuropathic pain.
    Anesthesia and analgesia, 2008, Volume: 107, Issue:2

    Topics: Adrenergic alpha-Agonists; Adrenergic alpha-Antagonists; Amines; Analgesics; Animals; Anticonvulsant

2008
Unmasking the tonic-aversive state in neuropathic pain.
    Nature neuroscience, 2009, Volume: 12, Issue:11

    Topics: Adenosine; Analgesics; Analysis of Variance; Animals; Calcium Channel Blockers; Clonidine; Condition

2009
A tropomyosine receptor kinase inhibitor blocks spinal neuroplasticity essential for the anti-hypersensitivity effects of gabapentin and clonidine in rats with peripheral nerve injury.
    The journal of pain, 2011, Volume: 12, Issue:1

    Topics: Acetylcholine; Amines; Analgesics; Animals; Carbazoles; Choline O-Acetyltransferase; Clonidine; Cycl

2011
Intrathecal gabapentin and clonidine synergistically inhibit allodynia in spinal nerve-ligated rats.
    Life sciences, 2010, Oct-23, Volume: 87, Issue:17-18

    Topics: Amines; Animals; Clonidine; Cyclohexanecarboxylic Acids; Disease Models, Animal; Dose-Response Relat

2010
Lesion of the rostral anterior cingulate cortex eliminates the aversiveness of spontaneous neuropathic pain following partial or complete axotomy.
    Pain, 2011, Volume: 152, Issue:7

    Topics: Analgesics; Animals; Avoidance Learning; Axotomy; Clonidine; Cocaine; Conditioning, Operant; Disease

2011
The function of alpha-2-adrenoceptors in the rat locus coeruleus is preserved in the chronic constriction injury model of neuropathic pain.
    Psychopharmacology, 2012, Volume: 221, Issue:1

    Topics: Action Potentials; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Antagonists; Adrenergic Up

2012
[Clonidine and dexmedetomidine's effect on the altered expressions of growth associated protein-43 mRNA in rat dorsal root ganglion during the development of chronic neuropathic pain].
    Zhonghua yi xue za zhi, 2012, Feb-21, Volume: 92, Issue:7

    Topics: Adrenergic alpha-2 Receptor Agonists; Animals; Clonidine; Dexmedetomidine; Ganglia, Spinal; GAP-43 P

2012
Dissociated modulation of conditioned place-preference and mechanical hypersensitivity by a TRPA1 channel antagonist in peripheral neuropathy.
    Pharmacology, biochemistry, and behavior, 2013, Volume: 104

    Topics: Acetanilides; Adrenergic alpha-2 Receptor Agonists; Animals; Clonidine; Conditioning, Psychological;

2013
[A case of effective treatment with clonidine ointment for herpetic neuralgia after bone marrow transplantation in a child].
    Masui. The Japanese journal of anesthesiology, 2002, Volume: 51, Issue:7

    Topics: Administration, Topical; Analgesics; Bone Marrow Transplantation; Child; Clonidine; Herpes Zoster; H

2002
Pharmacological characterisation of the rat brachial plexus avulsion model of neuropathic pain.
    Brain research, 2004, Aug-27, Volume: 1018, Issue:2

    Topics: Acetates; Amines; Analgesics; Analysis of Variance; Animals; Brachial Plexus; Brachial Plexus Neurop

2004
Nerve-stimulator-guided repeated pudendal nerve block for treatment of pudendal neuralgia.
    European journal of anaesthesiology, 2006, Volume: 23, Issue:5

    Topics: Analgesics; Analgesics, Opioid; Anesthetics, Local; Bupivacaine; Clonidine; Electric Stimulation; Ep

2006
Clonidine maintains intrathecal self-administration in rats following spinal nerve ligation.
    Pain, 2006, Dec-05, Volume: 125, Issue:3

    Topics: Analgesics; Animals; Clonidine; Hyperalgesia; Injections, Spinal; Male; Neuralgia; Pain Measurement;

2006
Opioid self-administration in the nerve-injured rat: relevance of antiallodynic effects to drug consumption and effects of intrathecal analgesics.
    Anesthesiology, 2007, Volume: 106, Issue:2

    Topics: Adenosine; Analgesics, Opioid; Animals; Clonidine; Dose-Response Relationship, Drug; Fentanyl; Heroi

2007
[Intrathecal injection of ketamine and clonidine for chronic neuropathic pain model in rats].
    Zhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences, 2007, Volume: 32, Issue:4

    Topics: Analgesics; Animals; Clonidine; Drug Combinations; Injections, Spinal; Ketamine; Male; Neuralgia; Ni

2007
Brain derived nerve growth factor induces spinal noradrenergic fiber sprouting and enhances clonidine analgesia following nerve injury in rats.
    Pain, 2008, Volume: 136, Issue:3

    Topics: Analgesics; Animals; Brain-Derived Neurotrophic Factor; Clonidine; Drug Combinations; Drug Synergism

2008
Clonidine potentiates the neuropathic pain-relieving action of MK-801 while preventing its neurotoxic and hyperactivity side effects.
    Brain research, 1998, Jan-19, Volume: 781, Issue:1-2

    Topics: Adrenergic alpha-Agonists; Analysis of Variance; Animals; Clonidine; Dizocilpine Maleate; Dose-Respo

1998
Effects of intrathecal morphine, baclofen, clonidine and R-PIA on the acute allodynia-like behaviours after spinal cord ischaemia in rats.
    European journal of pain (London, England), 2001, Volume: 5, Issue:1

    Topics: Adenosine; Adrenergic alpha-Agonists; Analgesics, Opioid; Animals; Baclofen; Behavior, Animal; Cloni

2001
Systemic tizanidine hydrochloride (Zanaflex) relieves thermal hyperalgesia in rats with an experimental mononeuropathy.
    Anesthesia and analgesia, 2001, Volume: 93, Issue:5

    Topics: Adrenergic alpha-Agonists; Animals; Clonidine; Disease Models, Animal; Hot Temperature; Hyperalgesia

2001
[Drug therapy for headache: (author's transl)].
    MMW, Munchener medizinische Wochenschrift, 1977, Apr-08, Volume: 119, Issue:14

    Topics: Analgesics; Anti-Inflammatory Agents; Antidepressive Agents; Clonidine; Dihydroergotamine; Ergotamin

1977
Postherpetic neuralgia: a possible application for topical clonidine.
    Anesthesiology, 1992, Volume: 76, Issue:6

    Topics: Administration, Topical; Aged; Clonidine; Herpesviridae Infections; Humans; Male; Neuralgia

1992