Status:
TERMINATED
Safety and Efficacy Study of Ethosuximide for the Treatment of Complex Regional Pain Syndrome (CRPS)
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborating Sponsors:
McGill University
Conditions:
Complex Regional Pain Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
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 diagno...
Eligibility Criteria
Inclusion
- 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
- 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 ability to accurately report treatment response;
- Participation in other clinical trial in the 30 days prior to enrolment.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00689585
Start Date
September 1 2008
End Date
July 1 2010
Last Update
May 13 2011
Active Locations (1)
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1
McGill University Health Centre
Montreal, Quebec, Canada, H3G 1A4