Complex Regional Pain Syndromes Clinical Trial
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)
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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