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

This study has been terminated.
(Recruitment difficult and enrolment low: decision was made to stop the study.)
Sponsor:
Collaborator:
Louise & Alan Edwards Foundation - McGill Centre for Research on Pain
Information provided by:
McGill University Health Center
ClinicalTrials.gov Identifier:
NCT00689585
First received: May 29, 2008
Last updated: May 11, 2011
Last verified: May 2011

May 29, 2008
May 11, 2011
September 2008
July 2010   (final data collection date for primary outcome measure)
Maximum tolerated dose (500mg-1500mg per day) and Safety profile [ Time Frame: up to 10 weeks ] [ Designated as safety issue: No ]
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.
Maximum tolerated dose (500mg-1500mg per day) and Safety profile [ Time Frame: Throughout the study: After disallowed drug cessation period ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00689585 on ClinicalTrials.gov Archive Site
  • Pain Intensity Scores on the Visual Analogue Scale (VAS) [ Time Frame: up to 7 weeks ] [ Designated as safety issue: No ]
    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)
  • Pain Intensity Scores on the Numerical Rating Scale (NRS) [ Time Frame: up to 5 weeks ] [ Designated as safety issue: No ]
    Pain Intensity using the Numerical Rating Scale will be captured by telephone every week during dose titration period (Days 3 and 6).
  • Neuropathic Pain Symptom Inventory (NPSI) [ Time Frame: up to 7 weeks ] [ Designated as safety issue: No ]
    Day 1 (First study visit post-disallowed drug cessation period) and 7 days after maximal-tolerated dose attained (Final Study Visit)
  • Short Form 12v2 (SF-12v2) [ Time Frame: up to 7 weeks ] [ Designated as safety issue: No ]
    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)
  • Short Form McGill Pain Questionnaire (SF-MPQ) [ Time Frame: up to 7 weeks ] [ Designated as safety issue: No ]
    Day 1 (First study visit post-disallowed drug cessation period) and 7 days after maximal-tolerated dose attained (Final Study Visit)
  • Efficacy: Pain Intensity - Visual Analogue Scale (VAS) [ Time Frame: Day 1 (First study visit post-disallowed drug cessation period) and 7 days after maximal-tolerated dose attained (Final Study Visit) ] [ Designated as safety issue: No ]
  • Efficacy: Pain Intensity - Numerical Rating Scale (NRS) [ Time Frame: Every week during dose titration period (Days 3 and 6) and 30 days after final study visit. ] [ Designated as safety issue: No ]
  • Efficacy: Pain Quality - Neuropathic Pain Symptom Inventory (NPSI) and Short Form McGill Pain Questionnaire (SF-MPQ) [ Time Frame: Day 1 (First study visit post-disallowed drug cessation period) and 7 days after maximal-tolerated dose attained (Final Study Visit) ] [ Designated as safety issue: No ]
  • Efficacy: Quality of Life - Short Form 12v2 (SF-12v2) [ Time Frame: Day 1 (First study visit post-disallowed drug cessation period) and 7 days after maximal-tolerated dose attained (Final Study Visit) ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety and Efficacy Study of Ethosuximide for the Treatment of Complex Regional Pain Syndrome (CRPS)
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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Complex Regional Pain Syndromes
  • Drug: Placebo
    250mg matching placebo capsules
  • 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.
    Other Name: Zarontin
  • Placebo Comparator: 1
    Intervention: Drug: Placebo
  • Experimental: 2
    Intervention: Drug: Ethosuximide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
4
July 2010
July 2010   (final data collection date for primary outcome measure)

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 ability to accurately report treatment response;
  • Participation in other clinical trial in the 30 days prior to enrolment.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00689585
GEN#07-062
No
Mark A. Ware, Prinicipal Investigator, McGill University Health Centre - Pain Centre
McGill University Health Center
Louise & Alan Edwards Foundation - McGill Centre for Research on Pain
Principal Investigator: Mark A Ware, MD McGill University Health Center
McGill University Health Center
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP