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Gabapentin Enacarbil Relieves Pain Associated With Restless Legs Syndrome: Presented at APS

By Kristina Rebelo

SAN DIEGO -- May 14, 2009 -- Gabapentin enacarbil (GEn) improves restless legs syndrome (RLS) while reducing associated pain, according to phase 3 results presented here at the 28th Annual Scientific Meeting of the American Pain Society (APS).

Results, which were presented on May 9, showed that at week 12 last observation carried forward (LOCF), significantly more patients treated with GEn reported a more than 50% reduction in pain compared with patients receiving a placebo (58.6% vs 35.2%; adjusted odds ratio = 2.6; 95% confidence interval, 1.5-4.5; P = .0006)

The 12-week, multicentre, randomised, double-blind, placebo-controlled Patient Improvement in Vital Outcomes Following Treatment for RLS (PIVOT RLS) study assessed the efficacy and tolerability of GEn 1,200 mg daily in patients with moderate to severe primary RLS.

Coprimary endpoints were mean change from baseline in International Restless Legs Scale (IRLS) total score. Patients recorded pain associated with RLS symptoms on an 11-point pain scale (0 = no pain; 10 = most intense pain imaginable) for 7 days before assessment.

Daniel M. Canafax, XenoPort, Inc., Santa Clara, California, and colleagues randomised patients to GEn extended release tablets 1,200 mg daily with food (n = 114) or a placebo (n = 108).

Of the patients treated with GEn, 100 completed the study (all placebo-treated patients completed the study). Patients who withdrew from the study before 2 weeks of randomisation were counted as nonresponders in the pain responder analysis. And those who had no pain at both baseline and week 12 were also counted as nonresponders. Average daily pain scores were calculated for each 7-day period.

GEn significantly improved mean IRLS total score versus placebo at week 12 LOCF (P = .0003). Overall, 89% of GEn-treated patients and 51% of placebo-treated patients reported baseline average daily RLS-associated pain scores of >0 and >=4, respectively.

Somnolence (27%) and dizziness (19%) were reported in the GEn group and in the placebo group (7% and 5%, respectively). These adverse events, although mild or moderate in intensity, led to the withdrawal of 5 patients in the GEn group (2 due to the somnolence, 3 to dizziness).

Funding for this study was provided by XenoPort, Inc.

[Presentation title: Gabapentin Enacarbil Relieves the Pain Associated With Restless Legs Syndrome. Abstract 134]

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