Study of Pregabalin in the Prevention of Central Neuropathic Pain in Acute Spinal Cord Injury
Information source: Nova Scotia Health Authority
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Spinal Cord Trauma; Pain
Intervention: Lyrica (Drug); matching placebo (Drug)
Phase: Phase 3
Sponsored by: Nova Scotia Health Authority
Official(s) and/or principal investigator(s):
Christine A. Short, Md FRCPC, Principal Investigator, Affiliation: Capital Health DHA Canada
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, 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.
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.
- 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
- 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
Locations and Contacts
N.S Rehabilitation Center ,Capital Health, Halifax, Nova Scotia B3h 4K4, Canada
Starting date: September 2009
Last updated: July 29, 2013