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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
4
250mg matching placebo capsules
500-1500mg/day over a 1-5 week dose titration period until maximal tolerated dose (MTD) attained, followed by 1 week MTD plateau period.
McGill University Health Centre
Montreal, Quebec, Canada
Maximum tolerated dose (500mg-1500mg per day) and Safety profile
Primary outcomes will consist of the dose attained during the study and the safety (adverse event) profile. Maximum timeframe on study drug is 6 weeks. Adverse events will be collected up to one month after the trial period ends.
Time frame: up to 10 weeks
Pain Intensity Scores on the Visual Analogue Scale (VAS)
Pain Intensity captured on Day 1 (First study visit post-disallowed drug cessation period) and 7 days after maximal-tolerated dose attained (Final Study Visit)
Time frame: up to 7 weeks
Pain Intensity Scores on the Numerical Rating Scale (NRS)
Pain Intensity using the Numerical Rating Scale will be captured by telephone every week during dose titration period (Days 3 and 6).
Time frame: up to 5 weeks
Neuropathic Pain Symptom Inventory (NPSI)
Day 1 (First study visit post-disallowed drug cessation period) and 7 days after maximal-tolerated dose attained (Final Study Visit)
Time frame: up to 7 weeks
Short Form 12v2 (SF-12v2)
Quality of Life measured on Day 1 (First study visit post-disallowed drug cessation period) and 7 days after maximal-tolerated dose attained (Final Study Visit)
Time frame: up to 7 weeks
Short Form McGill Pain Questionnaire (SF-MPQ)
Day 1 (First study visit post-disallowed drug cessation period) and 7 days after maximal-tolerated dose attained (Final Study Visit)
Time frame: up to 7 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.