Randomized trial of pramipexole for patients with restless legs syndrome (RLS) and RLS-related impairment of mood

Sleep Med. 2011 Jan;12(1):34-40. doi: 10.1016/j.sleep.2010.08.005. Epub 2010 Oct 20.


Objectives: Patients with restless legs syndrome (RLS) have an elevated prevalence of mood disorders compared with the general population. We investigated the change of RLS-related mood impairment during treatment of RLS with pramipexole, a dopamine D(3)/D(2) agonist.

Methods: Adults with moderate to very severe RLS were enrolled in a 12-week, double-blind, placebo-controlled Phase IV pramipexole trial. A moderate to very severe RLS-related mood disturbance at baseline (score ≥2 on Item 10 of the International RLS Study Group Rating Scale [IRLS]) was also required. Pramipexole (0.125 to 0.75 mg once daily) was flexibly titrated over the first 4 weeks.

Results: The intent-to-treat population comprised 199 patients on placebo and 203 on pramipexole. At week 12, adjusted mean total-score changes on IRLS were -14.2±0.7 for pramipexole and -8.1±0.7 for placebo (p<0.0001), and on the Beck Depression Inventory version II, -7.3±0.4 for pramipexole and -5.8±0.5 for placebo (p=0.0199). For IRLS item 10, the 12-week responder rate (reduction to no or mild mood disturbance) was 75.9% for pramipexole and 57.3% for placebo (p<0.0001). Study withdrawal rates were higher for placebo (20.5%) than for pramipexole (12.8%).

Conclusions: In patients with RLS-related mood disturbance, pramipexole improved RLS while also improving RLS-related mood impairment. Tolerability of pramipexole was similar to that in previous studies.

Publication types

  • Clinical Trial, Phase IV
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Affect / drug effects
  • Benzothiazoles / administration & dosage
  • Benzothiazoles / therapeutic use*
  • Dopamine Agonists / administration & dosage
  • Dopamine Agonists / therapeutic use*
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Middle Aged
  • Mood Disorders / drug therapy*
  • Mood Disorders / etiology
  • Pramipexole
  • Psychiatric Status Rating Scales
  • Restless Legs Syndrome / complications
  • Restless Legs Syndrome / drug therapy*
  • Restless Legs Syndrome / psychology
  • Treatment Outcome


  • Benzothiazoles
  • Dopamine Agonists
  • Pramipexole