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.
Latest Information Update: 10 Nov 2021
At a glance
- Drugs Pramipexole (Primary)
- Indications Restless legs syndrome
- Focus Therapeutic Use
- Sponsors Boehringer Ingelheim
- 02 Aug 2019 Planned number of patients changed from 367 to 520.
- 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.