Study to Determine if a Reduction in Pain Can be Measured in Spinal Cord Injured Patients Using a New Study Design

A Methodology Study to Assess the Ability of a Randomised, Double Blind, Placebo Controlled, Crossover Trial Design in Spinal Cord Injury Patients With Pain of Neuropathic Origin to Detect Improvement in Pain Endpoints Using Pregabalin as a Benchmark Compound

The study is designed to assess if spinal cord injury patients have reduced pain after taking either pregabalin or placebo in a cross over design. Patients had either pain at the level of their injury or below the level of their injury.

This methodology study was terminated on October 13, 2008 based on interim results for an exploratory, novel endpoint. The results of the primary analysis at the interim for N=12 patients showed results that generally favored pregabalin but were not statistically significant compared to placebo. Based on the estimated conditional power, this result is unlikely to change with full recruitment of N=24 patients and therefore the data monitoring committee recommended termination of the trial. The decision to terminate the trial was not based on any safety concerns.

Inclusion Criteria:

• subjects who are outpatients or inpatients
• written informed consent obtained (signed by the subject or the subject's legally acceptable representative)
• traumatic spinal cord injury of at least 1 year duration with a nonprogressive, i.e., chronic, stage of at least 6 months duration
• At-level neuropathic pain: spontaneous or evoked pain with neuropathic features (sharp, shooting, electric or burning pain sensation) in the region of sensory disturbance in a segmental pattern and located within two dermatomes above or below the level of spinal cord injury
• Below-level neuropathic pain: spontaneous or evoked pain with neuropathic features (sharp, shooting, electric or burning pain sensation) in the region of sensory disturbance located at least three dermatomes below the level of spinal cord injury

Exclusion Criteria:

• spinal cord injury (subjects with central pain and musculoskeletal pain must be able to make a distinction between the two)
• subjects who have previously not responded to 300 mg/day pregabalin: a non-responder is defined as a subject who has a reduction in pain score of less than 30% from baseline