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| Sponsors and Collaborators: |
McGill University Health Center Louise & Alan Edwards Foundation - McGill Centre for Research on Pain |
|---|---|
| Information provided by: | McGill University Health Center |
| ClinicalTrials.gov Identifier: | NCT00689585 |
Purpose
Pain remains the most debilitating symptom for adult patients suffering from complex regional pain syndrome (CRPS). Most CRPS patients gain little to no relief from current painkillers. The purpose of this study is to evaluate the efficacy and safety of ethosuximide in search of much-needed adjunctive therapy to relieve the pain and suffering associated with CRPS.
| Condition | Intervention | Phase |
|---|---|---|
|
Complex Regional Pain Syndrome |
Drug: Placebo Drug: Ethosuximide |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Single Centre. Parallel-Group, Double-Blinded, Randomized, Placebo-Controlled Pilot Clinical Trial on Ethosuximide for the Treatment of Complex Regional Pain Syndrome (CRPS) |
| Estimated Enrollment: | 12 |
| Study Start Date: | September 2008 |
| Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Placebo Comparator |
Drug: Placebo
250mg matching placebo capsules
|
| 2: Experimental |
Drug: Ethosuximide
500-1500mg/day over a 1-5 week dose titration period until maximal tolerated dose (MTD) attained, followed by 1 week MTD plateau period.
|
This is a single centre, parallel-group, double-blind, randomized, placebo-controlled pilot clinical trial for adults suffering from complex regional pain syndrome (CRPS).
Twelve (12) subjects diagnosed with CRPS will be enrolled and randomized to receive orally, either ethosuximide or placebo. If the maximum trial medication dosage (1500mg) is reached, the subject will be in the study for a maximum of 10 weeks from screening (Clinic Visit 1) to the end of the drug cessation period. The minimum period a subject could complete the study would be 4 weeks presuming they were not previously on any disallowed drugs and only found the 500mg dose tolerable.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Mark A Ware, MD | 514-934-1934 ext 42784 | mark.ware@muhc.mcgill.ca |
| Contact: Linda Ferguson | 514-934-1934 ext 44361 | linda.ferguson@muhc.mcgill.ca |
| Canada, Quebec | |
| McGill University Health Centre | Recruiting |
| Montreal, Quebec, Canada, H3G 1A4 | |
| Contact: Sylvie Toupin 514-934-1934 ext 44348 sylvie.toupin@mail.mcgill.ca | |
| Principal Investigator: Mark A Ware, MD | |
| Sub-Investigator: Yoram Shir, MD | |
| Sub-Investigator: Gary Bennet, PhD | |
| Principal Investigator: | Mark A Ware, MD | McGill University Health Center |
More Information
| Responsible Party: | McGill University Health Centre - Pain Centre ( Mark A. Ware, Prinicipal Investigator ) |
| Study ID Numbers: | GEN#07-062 |
| Study First Received: | May 29, 2008 |
| Last Updated: | March 10, 2009 |
| ClinicalTrials.gov Identifier: | NCT00689585 History of Changes |
| Health Authority: | Canada: Health Canada |
|
Complex Regional Pain Syndrome Reflex Sympathetic Dystrophy RSD Chronic Pain |
Ethosuximide Zarontin Anticonvulsant |
|
Autonomic Nervous System Diseases Reflex Sympathetic Dystrophy Neuromuscular Diseases Complex Regional Pain Syndromes Mental Disorders Peripheral Nervous System Diseases |
Ethosuximide Reflex Sympathetic Dystrophy Syndrome Pain Somatoform Disorders Anticonvulsants |
|
Disease Nervous System Diseases Pharmacologic Actions Pathologic Processes Autonomic Nervous System Diseases Complex Regional Pain Syndromes Neuromuscular Diseases Mental Disorders |
Therapeutic Uses Syndrome Peripheral Nervous System Diseases Ethosuximide Somatoform Disorders Central Nervous System Agents Anticonvulsants |