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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2012-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Spinal Cord Trauma Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Pregabalin, (other name) Lyrica

Study subjects wil be randomized to either the Pregabalin or Placebo group. There is a 5o ,50 chance of being in either group.

Group Type PLACEBO_COMPARATOR

Lyrica

Intervention Type DRUG

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.

pregabalin, drug

study subjects that are randomized to the placebo group will receive matching placebo

Group Type PLACEBO_COMPARATOR

matching placebo

Intervention Type DRUG

150 mg by mouth ,twice a day for 49 weeks

Interventions

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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.

Intervention Type DRUG

matching placebo

150 mg by mouth ,twice a day for 49 weeks

Intervention Type DRUG

Other Intervention Names

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Pregablin , also known as Lyrica, an approved drug.

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No