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

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.

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.

• Spinal Cord Trauma
• Pain

• 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
• 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

• 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.
  Interventions:

  • Drug: Lyrica
  • Drug: pregabalin
• Placebo Comparator: pregabalin, drug
  study subjects that are randomized to the placebo group will receive matching placebo
  Interventions:

  • Drug: matching placebo
  • Drug: matching placebo

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