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

• Status: Terminated
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nova Scotia Health Authority
• Treatments: Pregabalin

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study she will be un-blinded and, if on pregabalin, she will be weaned from the medication as quickly as is safe and withdrawn from the study.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