Study of Pregabalin in the Prevention of Central Neuropathic Pain in Acute Spinal Cord Injury

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Can Pregabalin Prevent the Development of Neuropathic Pain Following Spinal Cord Injury? A Double-Blind, Randomized, Placebo Controlled Trial.

Conditions
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Spinal Cord Trauma, Pain

Intervention / Treatment
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* Drug: Lyrica
* Drug: matching placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Pregabalin, (other name) Lyrica<br>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<br>* 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.<br>* Other names: Pregablin , also known as Lyrica, an approved drug.;|
| Placebo Comparator: pregabalin, drug<br>study subjects that are randomized to the placebo group will receive matching placebo | Drug: matching placebo<br>* 150 mg by mouth ,twice a day for 49 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome measures will be the development of Neuropathic Pain and intensity of pain . |  | the trial is 74 weeks in length | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcome measures will be Ashworth's Scale for spasticity and ASIA motor and Sensory Scores. |  | trail is 74 weeks in length | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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The outcome is to prevent Central Neuropathic Pain, participants will have suffered spinal cord trauma