Study of Pregabalin in the Prevention of Central Neuropathic Pain in Acute Spinal Cord Injury
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Purpose
This research study will test to see if people who receive pregabalin after their spinal cord injury will develop less nerve damage pain than people who do not receive it.
| Condition | Intervention | Phase |
|---|---|---|
|
Spinal Cord Trauma Pain |
Drug: Lyrica Drug: pregabalin Drug: matching placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Can Pregabalin Prevent the Development of Neuropathic Pain Following Spinal Cord Injury? A Double-Blind, Randomized, Placebo Controlled Trial. |
- The primary outcome measures will be the development of Neuropathic Pain and intensity of pain . [ Time Frame: the trial is 74 weeks in length ] [ Designated as safety issue: Yes ]
- Secondary outcome measures will be Ashworth's Scale for spasticity and ASIA motor and Sensory Scores. [ Time Frame: trail is 74 weeks in length ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 30 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Pregabalin
Study subjects wil be randomized to either the Pregabalin or Placebo group. There is a 5o ,50 chance of being in either group.
|
Drug: Lyrica
study participants will start will be on 150mg of Pregabalin or placebo capsules by mouth , twice a day.They will be on drug approx. 49 weeks and followed for another 49 weeks after stopping the medication.
Other Name: Pregablin , also known as Lyrica, an approved drug.
Drug: pregabalin
150 mg capsules by mouth twice a day for 49 weeks
Other Name: Lyrica
|
|
Placebo Comparator: pregabalin, drug
study subjects that are randomized to the placebo group will receive matching placebo
|
Drug: matching placebo
150 mg by mouth ,twice a day for 49 weeks
Drug: matching placebo
150 mg by mouth twice a day for 49 weeks
|
Detailed Description:
Pregabalin is one of the few agents that have demonstrated effectiveness in the treatment of central NeP in SCI. Research is now proving that it is possible to prevent the development of pain in certain conditions. Pregabalin has been proven effective in this area with post surgical pain. Therefore, after traumatic SCI there may be a small window of time where we could prevent the development of NeP by administering an agent like Pregabalin.
Objective: To test the hypothesis that pregabalin is an effective treatment in preventing post-spinal cord injury neuropathic pain.
Design: double-blind, placebo controlled, randomized, trial Setting: Spinal cord injury program, neurosurgery and tertiary care rehabilitation center Subjects: 30 patients with acute traumatic spinal cord injury Method: Pregabalin will be offered to patients with acute traumatic spinal cord injury pain in a double blind crossover, placebo control design.
Main Outcome Measures: The primary outcome measures will be the development of Neuropathic Pain and intensity of pain Secondary outcome measures will be Ashworth's Scale for spasticity and ASIA motor and Sensory Scores.
Results: To be determined. Conclusion: To be determined.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Eligible participants will be 18 years of age or older
- Have suffered a traumatic spinal cord injury (complete or incomplete)
- Be free of Neuropathic pain
- Be in stable medical condition
Exclusion Criteria:
- Pregnant or lactating women: Because we do not know the risks of pregabalin in pregnancy, females of child bearing years must have a negative pregnancy test (performed on screening and subsequent follow up visits) and be using a reliable method of birth control including oral or injectible birth control hormones, barriers, intrauterine devices or tubal ligation, or abstinence throughout the duration of the study.
- Should a female become pregnant while participating in the study she will be un-blinded and, if on pregabalin, she will be weaned from the medication as quickly as is safe and withdrawn from the study. Appropriate follow-up for any pregnancy complications will be conducted.
- Persons with known hypersensitivity to pregabalin or its constituents
- Persons with Neuropathic pain at the time of enrollment
- Persons with a chronic pain diagnoses that may interfere with the evaluation of the presence of Neuropathic pain
Contacts and Locations| Canada, Nova Scotia | |
| N.S Rehabilitation Center ,Capital Health | |
| Halifax, Nova Scotia, Canada, B3h 4K4 | |
| Principal Investigator: | Christine A. Short, Md FRCPC | Capital Health DHA Canada |
More Information
No publications provided
| Responsible Party: | Dr. Christine Short, QE11, Capital Health .N.S. Physical Medicine andRehabilitation Center |
| ClinicalTrials.gov Identifier: | NCT00879021 History of Changes |
| Other Study ID Numbers: | Pregabalin and SCI-Short |
| Study First Received: | April 8, 2009 |
| Last Updated: | June 21, 2011 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Capital District Health Authority, Canada:
|
The outcome is to prevent Central Neuropathic Pain participants will have suffered spinal cord trauma |
Additional relevant MeSH terms:
|
Neuralgia Spinal Cord Injuries Pain Neurologic Manifestations Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Signs and Symptoms Spinal Cord Diseases Central Nervous System Diseases Trauma, Nervous System |
Wounds and Injuries Pregabalin Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anticonvulsants |
ClinicalTrials.gov processed this record on May 23, 2013