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

Primary Purpose

Complex Regional Pain Syndromes

Status
Terminated
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Placebo
Ethosuximide
Sponsored by
McGill University Health Centre/Research Institute of the McGill University Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complex Regional Pain Syndromes focused on measuring Complex Regional Pain Syndrome, Reflex Sympathetic Dystrophy, RSD, Chronic Pain, Ethosuximide, Zarontin, Anticonvulsant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • McGill University Health Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
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).
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)
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)
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)

Full Information

First Posted
May 29, 2008
Last Updated
May 11, 2011
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
McGill University
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1. Study Identification

Unique Protocol Identification Number
NCT00689585
Brief Title
Safety and Efficacy Study of Ethosuximide for the Treatment of Complex Regional Pain Syndrome (CRPS)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Terminated
Why Stopped
Recruitment difficult and enrolment low: decision was made to stop the study.
Study Start Date
September 2008 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
McGill University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complex Regional Pain Syndromes
Keywords
Complex Regional Pain Syndrome, Reflex Sympathetic Dystrophy, RSD, Chronic Pain, Ethosuximide, Zarontin, Anticonvulsant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Title
2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
250mg matching placebo capsules
Intervention Type
Drug
Intervention Name(s)
Ethosuximide
Other Intervention Name(s)
Zarontin
Intervention Description
500-1500mg/day over a 1-5 week dose titration period until maximal tolerated dose (MTD) attained, followed by 1 week MTD plateau period.
Primary Outcome Measure Information:
Title
Maximum tolerated dose (500mg-1500mg per day) and Safety profile
Description
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
Secondary Outcome Measure Information:
Title
Pain Intensity Scores on the Visual Analogue Scale (VAS)
Description
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
Title
Pain Intensity Scores on the Numerical Rating Scale (NRS)
Description
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
Title
Neuropathic Pain Symptom Inventory (NPSI)
Description
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
Title
Short Form 12v2 (SF-12v2)
Description
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
Title
Short Form McGill Pain Questionnaire (SF-MPQ)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark A Ware, MD
Organizational Affiliation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada

12. IPD Sharing Statement

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

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