A randomized, double-blind, placebo-controlled, crossover study of XP13512/GSK1838262 in the treatment of patients with primary restless legs syndrome

To evaluate the efficacy and tolerability of XP13512/ GSK1838262, an investigational nondopaminergic agent for the treatment of moderate-to-severe primary restless legs syndrome (RLS). Randomized, double-blind, placebo-controlled, crossover trial. Nine US clinical sites. Thirty-eight treatment-naive...

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Bibliographic Details
Published in:Sleep (New York, N.Y.) N.Y.), 2009-02, Vol.32 (2), p.159-168
Main Authors: Kushida, Clete A, Walters, Arthur S, Becker, Philip, Thein, Stephen G, Perkins, A Thomas, Roth, Thomas, Canafax, Daniel, Barrett, Ronald W
Format: Article
Language:English
Subjects:
Adult
Aged
Carbamates - adverse effects
Carbamates - therapeutic use
Cross-Over Studies
Delayed-Action Preparations
Dose-Response Relationship, Drug
Double-Blind Method
Drug Administration Schedule
Female
gamma-Aminobutyric Acid - adverse effects
gamma-Aminobutyric Acid - analogs & derivatives
gamma-Aminobutyric Acid - therapeutic use
Humans
Male
Middle Aged
Polysomnography - drug effects
Restless Legs Syndrome
Restless Legs Syndrome - drug therapy
Wakefulness - drug effects
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Summary:To evaluate the efficacy and tolerability of XP13512/ GSK1838262, an investigational nondopaminergic agent for the treatment of moderate-to-severe primary restless legs syndrome (RLS). Randomized, double-blind, placebo-controlled, crossover trial. Nine US clinical sites. Thirty-eight treatment-naive subjects with RLS (mean +/- SD age 50.1 +/- 13.2 years). XP13512 1800 mg/day followed by placebo or placebo followed by XP13512 1800 mg/day for 14 days, with a 7-day washout between treatment periods. The primary endpoint was mean change from baseline International RLS Study Group rating scale (IRLS) total score on Day 14, analyzed using analysis of variance with sequence, period, and treatment as fixed effects and subjects within sequence as a random effect. XP13512 significantly reduced IRLS total score on Day 14 compared with placebo (mean +/- SD: XP13512 -12.1 +/-6.5, placebo -1.9 +/- 6.3; P < 0.0001). Polysomnographic data showed that XP13512 significantly improved sleep architecture on Day 14 compared with placebo (mean +/- SD change from baseline sleep time [minutes]: stage 1: XP13512 -9.8 +/- 23.9, placebo 0.4 +/-23.2; adjusted P
ISSN:0161-8105
1550-9109
DOI:10.1093/sleep/32.2.159