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

Condition(s) targeted: Spinal Cord Trauma; Pain

Intervention: Lyrica (Drug); pregabalin (Drug); matching placebo (Drug); matching placebo (Drug)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: Capital District Health Authority, Canada

Official(s) and/or principal investigator(s):
Christine A. Short, Md FRCPC, Principal Investigator, Affiliation: Capital Health DHA Canada

Overall contact:
Dr. Christine A. Short, MD FRCPC, Phone: 902-473-1409, Email: christine.short@cdha.nshealth.ca

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.

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

Study design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: The primary outcome measures will be the development of Neuropathic Pain and intensity of pain .

Secondary outcome: Secondary outcome measures will be Ashworth's Scale for spasticity and ASIA motor and Sensory Scores.

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.

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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

Dr. Christine A. Short, MD FRCPC, Phone: 902-473-1409, Email: christine.short@cdha.nshealth.ca

N.S Rehabilitation Center ,Capital Health, Halifax, Nova Scotia B3h 4K4, Canada

Starting date: September 2009
Last updated: July 8, 2009