TerminatedPhase 2

Safety and Efficacy Study of Ethosuximide for the Treatment of Complex Regional Pain Syndrome (CRPS)

Stopped: Recruitment difficult and enrolment low: decision was made to stop the study.

Canada4 participantsStarted 2008-09

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male or female, age ≥18 years old; * Diagnosis of Complex Regional Pain Syndrome (CRPS) using International Association for the Study of Pain criteria \>6 months; * Normal liver function (AST level \<3x normal level); * Normal kidney function (serum creatinine \<133µmol/L); * Full blood count, haematocrit \>38%; * Willing and able to give informed consent and of completing study questionnaires; * Stable (no change in past two months) but suboptimal pain pharmacotherapy (i.e. additional pain control felt by patient and physician to be necessary); * Able to attend research centre according to the visit schedule; * Women of child-bearing potential must be using a reliable form of contraception i.e. oral contraceptives, a barrier method (condom or diaphragm), intra-uterine device or abstinence. Exclusion Criteria: * Optimal response to opioids, antidepressants, anticonvulsants or anti- inflammatory medications; * Any history or indication of kidney or liver disease; * Any history of alcohol abuse; * Presence of diabetes; * Subjects taking other anti-epileptic drugs, including gabapentin, pregabalin, topiramate, phenytoin, carbamazepine, and oxcarbazepine; * Pregnancy (a serum bHCG pregnancy test will be performed as part of the initial blood panel); * Known or suspected allergy to succinimides, ethosuximide, methsuximide (Celontin®), phensuximide; * Any history of mental illness or disorder, which in the investigators opinion, interferes with the subjects…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Maximum tolerated dose (500mg-1500mg per day) and Safety profile

Timeframe: up to 10 weeks

Trial details

NCT IDNCT00689585

SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-07

View on ClinicalTrials.gov More Complex Regional Pain Syndromes trials