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A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Tolerability of Gabapentin Enacarbil in Subjects with Restless Legs Syndrome
Gabapentin enacarbil’s effects and side effects in restless legs syndrome: a controlled clinical trial
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Abstract
325 subjects were randomized to evaluate the efficacy of gabapentin enacarbil (GEn) 1200 mg and 600 mg against placebo in treating moderate-to-severe restless legs syndrome.
- GEn 1200 mg significantly reduced the mean International Restless Legs Scale (IRLS) total score from 23.2 to 10.2, compared to placebo which decreased from 23.8 to 14.0.
- 77.5% of subjects receiving GEn 1200 mg were rated as 'very much' or 'much' improved on the Clinical Global Impression-Improvement scale, compared to 44.8% of placebo subjects.
- GEn 600 mg also significantly improved the IRLS total score and showed 72.8% of subjects as CGI-I responders compared to 44.8% in the placebo group.
- GEn significantly enhanced sleep outcomes based on various subjective sleep measures when compared to placebo.
- The most common adverse events reported were somnolence and dizziness, with a dose-dependent increase in dizziness.
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