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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 is a Phase 4 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 404 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00375284
The ClinicalTrials.gov registry entry for NCT00375284 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 404 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Pramipexole is the first listed.
NCT00375284 reports 0 study locations.
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.
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