Study of Pregabalin in the Prevention of Central Neuropathic Pain in Acute Spinal Cord Injury
|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 ]
|Study Start Date:||September 2009|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Placebo Comparator: Pregabalin, (other name) Lyrica
Study subjects wil be randomized to either the Pregabalin or Placebo group. There is a 5o ,50 chance of being in either group.
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.
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00879021
|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|