deltatrials
Completed PHASE4 INTERVENTIONAL NCT00349531

A Phase IV Trial With Pramipexole to Investigate the Effects on RLS Symptoms and Sleep Disturbance in Patients With RLS

A Phase IV Randomised, Double-blind, Placebo-controlled, Dose Titration Trial With Pramipexole (Sifrol®, Mirapexin®) 0.125-0.75 mg/Day Per os for 12 Weeks to Investigate the Effects on RLS Symptoms (IRLS) and Sleep Disturbance (MOS Sleep Scale) in Out-patients With Idiopathic Restless Legs Syndrome

Sponsor: Boehringer Ingelheim

Interventions Pramipexole
Updated 6 times since 2017 Last updated: May 18, 2012 Started: Jul 31, 2006 Primary completion: May 31, 2007
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE4 clinical study on Restless Legs Syndrome, this trial is completed. The trial is conducted by Boehringer Ingelheim and has accumulated 6 data snapshots since 2006. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 9 months · monthly snapshotCompleted

Change History

6 versions recorded
  1. Sep 2025 — Present [monthly]

    Completed PHASE4

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE4

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE4

  4. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE4

  5. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE4

Show 1 earlier version
  1. Jan 2017 — Jun 2018 [monthly]

    Completed PHASE4

    First recorded

Jul 2006

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 .