Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00375284 · ClinicalTrials.gov registry record · Phase 4
A 6 Week Trial to Study the Efficacy and Safety of a Starting Dose 0.25 mg Pramipexole (Mirapex) in Patients With RLS
A Phase 4 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 4
- Development phase
- 404
- Enrollment target
NCT00375284: Completed Phase 4 study, sponsored by Boehringer Ingelheim.
NCT00375284 is a Phase 4 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 404 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00375284, a Phase 4 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 404 participants
- Enrollment target
Study Summary
This trial is a 6-week, double-blind, randomized, active and placebo-controlled parallel-group study with a primary objective of comparison of starting doses of pramipexole fixed-dose (0.25 mg daily) and pramipexole titrated-dose (0.125 mg qd for 1 week, then 0.25 mg qd for the remaining 5 weeks) with placebo to evaluate efficacy and safety in treating RLS symptoms in patients diagnosed with idiopathic RLS. The secondary objectives of this study will be to assess the onset of action of symptomatic relief of RLS for pramipexole with daily assessment of PGI and modified IRLS during two intervals of the first 2 weeks (Days 2, 3 and 4 and Days 9, 10, and 11) and assessment of IRLS, PGI and CGI-I at Weeks 1, 2, 4 and 6 (CGI-I additionally on Day 3).
Interventions
- DRUG Pramipexole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 404 participants |
| Start Date | 2006-09 |
| Phase | Phase 4 |
What the finished NCT00375284 record still lists
NCT00375284 is an interventional study that assigns participants to a tested intervention. The registered 404 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (22% lower).
The record links to 0 conditions, and to 1 intervention - of which Pramipexole is the first listed.
NCT00375284 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00375284 about?
NCT00375284 is a clinical study titled "A 6 Week Trial to Study the Efficacy and Safety of a Starting Dose 0.25 mg Pramipexole (Mirapex) in Patients With RLS". This trial is a 6-week, double-blind, randomized, active and placebo-controlled parallel-group study with a primary objective of comparison of starting doses of pramipexole fixed-dose (0.25 mg daily) and pramipexole titrated-dose (0.125 mg qd for 1 week, then 0.25 mg qd for the remaining 5 weeks) wi...
What is the current status of trial NCT00375284?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 404 participants. The study started on 2006-09.
What interventions are being tested in trial NCT00375284?
The interventions under investigation include: Pramipexole (DRUG).
Who is sponsoring clinical trial NCT00375284?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00375284's enrollment target sits among peer trials
404 209th of 2000 higher than 1,791 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05049057 · 404 participants · Phase 2
Treatment of Acute PTH With a CGRP Receptor mAb in Military Service Members and Civilians With mTBI
- NCT05611242 · 404 participants · Phase 3
Proximal Internal Carotid Artery Acute Stroke Secondary to Tandem or Local Occlusion Thrombectomy Trial
- NCT06072612 · 404 participants · Phase 3
Study of the Bria-IMT Regimen and CPI vs Physicians' Choice in Advanced Metastatic Breast Cancer.
- NCT05576350 · 405 participants · NA
TRAC-ER Intervention to Reduce Risky Alcohol Use and HIV Risk
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia