Completed PHASE3 NCT00133198

Efficacy and Safety of Pramipexole Compared to Placebo in the Treatment of Restless Legs Syndrome (RLS)

A Randomized, Double-blind, Placebo-controlled, Parallel Group Clinical Trial Comparing Fixed Doses of 0.25 mg, 0.50 mg and 0.75 mg Pramipexole (Mirapex®) Administered Orally to Investigate the Safety and Efficacy in Patients With Idiopathic Restless Legs Syndrome for 12 Weeks

Sponsor: Boehringer Ingelheim

Conditions Restless Legs Syndrome

Interventions Pramipexole

Updated 6 times since 2017 Last updated: Nov 7, 2013 Started: Apr 30, 2004 Primary completion: Feb 28, 2005 Completion: Feb 28, 2005

A PHASE3 clinical study on Restless Legs Syndrome, this trial is completed. The trial is conducted by Boehringer Ingelheim and has accumulated 6 data snapshots since 2004. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

Change History

6 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3
Jun 2018 — Jan 2021 [monthly]

Completed PHASE3

▶ Show 1 earlier version

Jan 2017 — Jun 2018 [monthly]

Completed PHASE3

First recorded

Apr 2004

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Boehringer Ingelheim

Data source: Boehringer Ingelheim

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Albuquerque, United States , Alexandria, United States , Atlanta, United States , Augusta, United States , Baton Rouge, United States , Brandon, United States , Chevy Chase, United States , Cincinnati, United States , Cleveland, United States , Columbia, United States and 32 more locations