Pregabalin versus pramipexole: effects on sleep disturbance in restless legs syndrome.

ABSTRACT:

Study objectives

To compare pregabalin versus placebo and pramipexole for reducing restless legs syndrome (RLS)-related sleep disturbance.

Design

Randomized, double-blinded, crossover trial.

Setting

Twenty-three US sleep centers.

Participants

Eighty-five individuals with moderate to severe idiopathic RLS and associated sleep disturbance.

Interventions

Participants were randomized across 6 treatment sequences comprising three 4-week periods on pregabalin 300 mg/day (n = 75), pramipexole 0.5 mg/day (n = 76), or placebo (n = 73).

Measurements and results

Polysomnography was conducted over 2 nights at the end of each period. Primary (wake after sleep onset [WASO], pregabalin vs placebo) and key secondary endpoints were analyzed for statistical signifi

SUBMITTER: Garcia-Borreguero D 

PROVIDER: S-EPMC4044751 | biostudies-literature | 2014 Apr

REPOSITORIES: biostudies-literature