Complex Regional Pain SyndromesPhase 2NCT00689585
Safety and Efficacy Study of Ethosuximide for the Treatment of Complex Regional Pain Syndrome (CRPS)
A Phase 2 study testing Ethosuximide in people with Complex Regional Pain Syndromes, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complex Regional Pain Syndromes
- What is being tested?
- Ethosuximide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2008to Jul 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Complex Regional Pain Syndromes
- Being tested
- Placebo, Ethosuximide
- Keywords
- Complex Regional Pain Syndrome, Reflex Sympathetic Dystrophy, RSD, Chronic Pain, Ethosuximide, Zarontin, Anticonvulsant
- Medical subject headings
- Complex Regional Pain Syndromes, Reflex Sympathetic Dystrophy, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
250mg matching placebo capsules
EthosuximideDrug
Also called Zarontin
500-1500mg/day over a 1-5 week dose titration period until maximal tolerated dose (MTD) attained, followed by 1 week MTD plateau period.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Drug: Placebo |
| 2 | Experimental | Not described Receives: Drug: Ethosuximide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 10 weeks
Secondary outcomes (5)
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)
Measured: up to 7 weeks
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).
Measured: up to 5 weeks
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)
Measured: up to 7 weeks
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)
Measured: up to 7 weeks
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)
Measured: up to 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2008 (estimated)
- Study startSep 2008
- Primary completionJul 2010
- Study completionJul 2010
Why it stopped: Recruitment difficult and enrolment low: decision was made to stop the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Regional Pain SyndromesStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University
- Investigators
- Mark A Ware, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00689585
- Sponsor's protocol ID
- GEN#07-062
- Status last verified
- May 2011
- First submitted
- 29 May 2008
- Last updated
- 13 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00689585
- Acronym / sponsor ID
- GEN#07-062
- Conditions
- Complex Regional Pain Syndromes
- Keywords
- Complex Regional Pain Syndrome, Reflex Sympathetic Dystrophy, RSD, Chronic Pain, Ethosuximide, Zarontin, Anticonvulsant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment difficult and enrolment low: decision was made to stop the study.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- McGill University
- Study start
- Sep 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 3 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Placebo |
| 2 | Experimental | Drug: Ethosuximide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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%;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo250mg matching placebo capsules | Drug | 1 |
| EthosuximideAlso: Zarontin500-1500mg/day over a 1-5 week dose titration period until maximal tolerated dose (MTD) attained, followed by 1 week MTD plateau period. | Drug | 2 |
Primary outcome
Maximum tolerated dose (500mg-1500mg per day) and Safety profile
Time frame: up to 10 weeks
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.
5 secondary outcomes
Pain Intensity Scores on the Visual Analogue Scale (VAS)
Time frame: up to 7 weeks
Pain Intensity Scores on the Numerical Rating Scale (NRS)
Time frame: up to 5 weeks
Neuropathic Pain Symptom Inventory (NPSI)
Time frame: up to 7 weeks
Short Form 12v2 (SF-12v2)
Time frame: up to 7 weeks
Short Form McGill Pain Questionnaire (SF-MPQ)
Time frame: up to 7 weeks
Results and safety
The study was stopped early (reason given: Recruitment difficult and enrolment low: decision was made to stop the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2011.
Related trials for Complex Regional Pain Syndromes
Enrolling by invitationPhase 4
Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome
Complex Regional Pain Syndrome, Chronic Pain
RecruitingPhase 3
Evaluation of IV AMBTX-01 (Neridronate) for Treatment of CRPS Type 1 (CRPS-RISE)
Complex Regional Pain Syndrome Type I
Recruiting
The Effectiveness of Conservative Treatment in Patients With Complex Regional Pain Syndrome.
CRPS (Complex Regional Pain Syndromes)
RecruitingPhase 3
Phase 3, Open-Label Extension Study of AMBTX-01 (Neridronate) for Complex Regional Pain Syndrome Type 1
Complex Regional Pain Syndrome Type I
Active, not recruiting
Transcranial Magnetic Stimulation for Chronic Neuropathic Pain
Chronic Neuropathic Pain, Post-Stroke Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark A Ware, MD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ethosuximide in people with Complex Regional Pain Syndromes, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Recruitment difficult and enrolment low: decision was made to stop the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (500mg-1500mg per day) and Safety profile (time frame: up to 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2011.