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Pregabalin in central neuropathic pain associated with spinal cord injury

A placebo-controlled trial

From the Pain Management Research Institute (P.J.S., M.J.C.), University of Sydney, Royal North Shore Hospital, Sydney, NSW, Australia; International Medical Research (A.O.), Pfizer Global Pharmaceuticals, Freiburg, Germany; and Pfizer Pharmaceuticals Group (T.G., R.C., T.K.M.), New York, NY.

Address correspondence and reprint requests to Dr. Philip J. Siddall, Pain Management and Research Institute, University of Sydney, Royal North Shore Hospital, Sydney, NSW, 2065, Australia; e-mail: phils{at}med.usyd.edu.au

Objective: To evaluate pregabalin in central neuropathic pain associated with spinal cord injury.

Methods: A 12-week, multicenter study of patients randomized to either flexible-dose pregabalin 150 to 600 mg/day (n = 70) or placebo (n = 67), administered BID. Patients were allowed to remain on existing, stable pain therapy. The primary efficacy variable was the endpoint mean pain score, derived from patients’ last 7 days daily pain diary entries. Key secondary endpoints included pain responder rates, the SF-MPQ, sleep interference, mood, and the patient global measure of change.

Results: The mean baseline pain score was 6.54 in the pregabalin group and 6.73 in the placebo group. The mean endpoint pain score was lower in the pregabalin group (4.62) than the placebo group (6.27; p < 0.001), with efficacy observed as early as week 1 and maintained for the duration of the study. The average pregabalin dose after the 3-week stabilization phase was 460 mg/day. Pregabalin was significantly superior to placebo in endpoint assessments on the SF-MPQ. The 30% and 50% pain responder rates were higher with pregabalin than placebo (p < 0.05). Pregabalin was associated with improvements in disturbed sleep (p < 0.001) and anxiety (p < 0.05), and more patients reported global improvement at endpoint in the pregabalin group (p < 0.001). Mild or moderate, typically transient, somnolence and dizziness were the most common adverse events.

Conclusions: Pregabalin 150 to 600 mg/day was effective in relieving central neuropathic pain, improving sleep, anxiety, and overall patient status in patients with spinal cord injury.

Supported by Pfizer Global Pharmaceuticals, New York, NY.

Disclosures: Drs. Otte, Griesing, Chambers, and Murphy are employees of Pfizer. Dr. Siddall and Prof. Cousins have received an honorarium for a presentation at a Pfizer-sponsored symposium at an international meeting.

Received October 24, 2005. Accepted in final form August 14, 2006.

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