A Phase IV Randomised, Double-Blind, Placebo-Controlled, Dose Titration Trial With 0.125-0.75 mg/Day Pramipexole (Sifrol, Mirapexin) Orally for 12 Weeks to Investigate the Safety and Efficacy in Out-Patients With Idiopathic Restless Legs Syndrome Associated With Mood Disturbances.

Trial Profile

A Phase IV Randomised, Double-Blind, Placebo-Controlled, Dose Titration Trial With 0.125-0.75 mg/Day Pramipexole (Sifrol, Mirapexin) Orally for 12 Weeks to Investigate the Safety and Efficacy in Out-Patients With Idiopathic Restless Legs Syndrome Associated With Mood Disturbances.

Completed
Phase of Trial: Phase IV

Latest Information Update: 02 Jun 2011

At a glance

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

    • 20 May 2009 Actual initiation date (Jul 2006) added, patient numbers amended from 402 to 404 as reported by ClinicalTrials.gov.
    • 26 Aug 2008 Results have been published in the proceedings of the 12th Congress of the European Federation of Neurological Societies.
    • 26 Aug 2008 Results presented at the 12th European Federation of Neurological Sciences annual congress, as reported in a Boehringer Ingelheim media release.
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