Gabapentin Enacarbil in Restless Legs Syndrome

Aug 12, 2009Clinical neuropharmacology

Gabapentin enacarbil’s effects in restless legs syndrome: a 2-week controlled trial

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Abstract

Gabapentin enacarbil at 1200 mg resulted in a mean change of -16.1 in the International Restless Legs Scale total score compared to -8.9 for placebo.

The efficacy of gabapentin enacarbil at 1200 mg was significantly greater than placebo, with a treatment difference of -7.2.
Investigator-rated Clinical Global Impression-Improvement scale outcomes also favored gabapentin enacarbil at 1200 mg over placebo.
Gabapentin enacarbil at 600 mg showed a mean change from baseline IRLS total score of -9.1, which was similar to placebo.
Common treatment-emergent adverse events included somnolence (36% for 1200 mg) and dizziness (18% for 1200 mg), mostly mild or moderate.
Both doses of gabapentin enacarbil were generally well tolerated.

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OBJECTIVES: Assess the efficacy and tolerability of gabapentin enacarbil (GEn), a transported prodrug of gabapentin with improved gabapentin exposure, in adults with moderate-to-severe primary restless legs syndrome.

METHODS: This 14-day, double-blind, randomized, controlled trial of GEn at 1200 or 600 mg or placebo taken once daily, evaluated the mean change from baseline International Restless Legs Scale (IRLS) total score at end of treatment (day 14:primary comparison, GEn at 1200 mg vs placebo). Secondary end points included Clinical Global Impression-Improvement scale outcomes at day 14.

RESULTS: Ninety-five subjects were randomized (GEn: 1200 mg, n = 33 and 600 mg, n = 29; placebo, n = 33); 2 subjects (GEn at 1200 mg) withdrew because of adverse events. At day 14,the mean (SD) change from baseline IRLS total score was significantly greater with GEn at 1200 mg (-16.1 [7.93]) compared with placebo (-8.9 [7.72]; adjusted mean treatment difference, -7.2; P < 0.0001). Investigator-rated Clinical Global Impression-Improvement scale responses also significantly favored GEn at 1200 mg compared with placebo (P G 0.0001).The mean (SD) change from baseline IRLS total score with GEn at 600 mg at day 14 was -9.1 (5.95), similar to placebo. The most commonly reported treatment-emergent adverse events were somnolence (GEn: 1200 mg, 36% and 600 mg, 14%; placebo,15%) and dizziness (GEn: 1200 mg, 18% and 600 mg, 14%; placebo, 3%), most of which were rated mild or moderate in intensity.

CONCLUSIONS: Gabapentin enacarbil at 1200 mg significantly improved restless legs syndrome symptoms compared with placebo. Efficacy outcomes for GEn at 600 mg were similar to placebo. Both GEn doses were generally well tolerated.

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Gabapentin Enacarbil in Restless Legs Syndrome

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