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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00879021
• Other study ID #: Pregabalin and SCI-Short
• Status: Terminated
• Phase: Phase 3
• First received: April 8, 2009
• Last updated: July 29, 2013
• Start date: September 2009
• Est. completion date: June 2012

Study information

• Verified date: July 2013
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Neuralgia
• Pain
• Spinal Cord Injuries
• Spinal Cord Trauma

Intervention

Drug:
• Lyrica
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.
• matching placebo
150 mg by mouth ,twice a day for 49 weeks

Locations

Country	Name	City	State
Canada	N.S Rehabilitation Center ,Capital Health	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
Nova Scotia Health Authority

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measures will be the development of Neuropathic Pain and intensity of pain .		the trial is 74 weeks in length	Yes
Secondary	Secondary outcome measures will be Ashworth's Scale for spasticity and ASIA motor and Sensory Scores.		trail is 74 weeks in length	Yes