A Phase IV Randomised, Double-Blind, Placebo-Controlled, Dose Titration Trial With Pramipexole (Sifrol, Mirapexin) 0.125-0.75 mg/Day Per os to Investigate the Long-Term Efficacy, Safety and Tolerability in Patients With Idiopathic Moderate to Severe Restless Legs Syndrome for 26 Weeks Followed by a 26 Week Open-Label Extension Treatment Period.

Trial Profile

A Phase IV Randomised, Double-Blind, Placebo-Controlled, Dose Titration Trial With Pramipexole (Sifrol, Mirapexin) 0.125-0.75 mg/Day Per os to Investigate the Long-Term Efficacy, Safety and Tolerability in Patients With Idiopathic Moderate to Severe Restless Legs Syndrome for 26 Weeks Followed by a 26 Week Open-Label Extension Treatment Period.

Completed
Phase of Trial: Phase IV

Latest Information Update: 26 Feb 2017

At a glance

  • Drugs Pramipexole (Primary)
  • Indications Restless legs syndrome
  • Focus Therapeutic Use
  • Sponsors Boehringer Ingelheim
  • Most Recent Events

    • 07 Jun 2009 Results were presented at the 13th International Congress of Parkinson's Disease and Movement Disorders.
    • 30 Apr 2009 Results published in the proceedings of the 61st Annual Meeting of the American Academy of Neurology.
    • 27 Jan 2009 Official Title amended as reported by ClinicalTrials.gov.
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