Status:
TERMINATED
Study of Pregabalin in the Prevention of Central Neuropathic Pain in Acute Spinal Cord Injury
Lead Sponsor:
Nova Scotia Health Authority
Conditions:
Spinal Cord Trauma
Pain
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
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
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 certa...
Eligibility Criteria
Inclusion
- 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
- 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study she will be un-blinded and, if on pregabalin, she will be weaned from the medication as quickly as is safe and withdrawn from the study.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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00879021
Start Date
September 1 2009
End Date
June 1 2012
Last Update
July 30 2013
Active Locations (1)
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1
N.S Rehabilitation Center ,Capital Health
Halifax, Nova Scotia, Canada, B3h 4K4