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NCT00133198 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Boehringer Ingelheim.

Completed
Registry status
Phase 3
Development phase
345
Enrollment target

NCT00133198: Completed Phase 3 study, sponsored by Boehringer Ingelheim.

NCT00133198 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 345 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00133198, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.

COMPLETED
Registry status
Phase 3
Development phase
345 participants
Enrollment target

Study Summary

A 12 week clinical trial was conducted in the United States in order to compare pramipexole (Mirapex®) versus placebo for the ability to reduce the symptoms of restless legs syndrome in adult subjects.

Interventions

  • DRUG Pramipexole

Trial Details

FieldValue
Enrollment Target 345 participants
Start Date 2004-04
Est. Completion 2005-02
Phase Phase 3
Boehringer Ingelheim

515 total trials

What the finished NCT00133198 record still lists

NCT00133198 is an interventional study that assigns participants to a tested intervention. The registered 345 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower).

The record links to 0 conditions, and to 1 intervention - of which Pramipexole is the first listed.

NCT00133198 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00133198 about?

NCT00133198 is a clinical study titled "Efficacy and Safety of Pramipexole Compared to Placebo in the Treatment of Restless Legs Syndrome (RLS)". A 12 week clinical trial was conducted in the United States in order to compare pramipexole (Mirapex®) versus placebo for the ability to reduce the symptoms of restless legs syndrome in adult subjects.

What is the current status of trial NCT00133198?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 345 participants. The study started on 2004-04. Estimated completion is 2005-02.

What interventions are being tested in trial NCT00133198?

The interventions under investigation include: Pramipexole (DRUG).

Who is sponsoring clinical trial NCT00133198?

This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00133198's enrollment target sits among peer trials

345 1050th of 2000 higher than 951 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00133198, the US trial registry maintained by the National Library of Medicine. NCT00133198 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.