A 6 Week Trial to Study the Efficacy and Safety of a Starting Dose 0.25 mg Pramipexole (Mirapex) in Patients With RLS
Public ClinicalTrials.gov record NCT00375284. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase IV Randomised, Double-blind, Active and Placebo-controlled, 6-week Trial to Investigate the Efficacy and Safety of a Starting (and Fixed) Dose 0.25 mg Pramipexole (Mirapex®) in Patients With Idiopathic Restless Legs Syndrome
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT00375284
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 404 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 2006 (Type not available)
- Primary completion
- Jul 2007 (Actual)
- Completion
- Not listed
- Last update posted
- Oct 31, 2013
Started 2006
United States locations
- U.S. sites
- 52
- U.S. states
- 25
- U.S. cities
- 50
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 248.616.065 Boehringer Ingelheim Investigational Site | Birmingham | Alabama | — | — |
| 248.616.028 Boehringer Ingelheim Investigational Site | Dothan | Alabama | — | — |
| 248.616.035 Boehringer Ingelheim Investigational Site | Mesa | Arizona | — | — |
| 248.616.025 Boehringer Ingelheim Investigational Site | Peoria | Arizona | — | — |
| 248.616.073 Boehringer Ingelheim Investigational Site | Phoenix | Arizona | — | — |
| 248.616.067 Boehringer Ingelheim Investigational Site | Tucson | Arizona | — | — |
| 248.616.009 Boehringer Ingelheim Investigational Site | Fayetteville | Arkansas | — | — |
| 248.616.040 Boehringer Ingelheim Investigational Site | Foothill Ranch | California | — | — |
| 248.616.062 Boehringer Ingelheim Investigational Site | Fullerton | California | — | — |
| 248.616.050 Boehringer Ingelheim Investigational Site | Pasadena | California | — | — |
| 248.616.031 Boehringer Ingelheim Investigational Site | Colorado Springs | Colorado | — | — |
| 248.616.017 Boehringer Ingelheim Investigational Site | Pueblo | Colorado | — | — |
| 248.616.071 Boehringer Ingelheim Investigational Site | Wallingford | Connecticut | — | — |
| 248.616.043 Boehringer Ingelheim Investigational Site | DeLand | Florida | — | — |
| 248.616.014 Boehringer Ingelheim Investigational Site | Jacksonville | Florida | — | — |
| 248.616.020 Boehringer Ingelheim Investigational Site | Naples | Florida | — | — |
| 248.616.048 Boehringer Ingelheim Investigational Site | Pembroke Pines | Florida | — | — |
| 248.616.072 Boehringer Ingelheim Investigational Site | Spring Hill | Florida | — | — |
| 248.616.018 Boehringer Ingelheim Investigational Site | St. Petersburg | Florida | — | — |
| 248.616.049 Boehringer Ingelheim Investigational Site | Augusta | Georgia | — | — |
| 248.616.033 Boehringer Ingelheim Investigational Site | Columbus | Georgia | — | — |
| 248.616.057 Boehringer Ingelheim Investigational Site | Macon | Georgia | — | — |
| 248.616.066 Boehringer Ingelheim Investigational Site | Savannah | Georgia | — | — |
| 248.616.047 Boehringer Ingelheim Investigational Site | Stockbridge | Georgia | — | — |
| 248.616.059 Boehringer Ingelheim Investigational Site | Chicago | Illinois | — | — |
| 248.616.045 Boehringer Ingelheim Investigational Site | Lenexa | Kansas | — | — |
| 248.616.061 Boehringer Ingelheim Investigational Site | Olathe | Kansas | — | — |
| 248.616.060 Boehringer Ingelheim Investigational Site | Baton Rouge | Louisiana | — | — |
| 248.616.058 Boehringer Ingelheim Investigational Site | Brighton | Massachusetts | — | — |
| 248.616.051 Boehringer Ingelheim Investigational Site | Wellesley Hills | Massachusetts | — | — |
| 248.616.001 Boehringer Ingelheim Investigational Site | Minneapolis | Minnesota | — | — |
| 248.616.004 Boehringer Ingelheim Investigational Site | Jackson | Mississippi | — | — |
| 248.616.064 Boehringer Ingelheim Investigational Site | Florissant | Missouri | — | — |
| 248.616.016 Boehringer Ingelheim Investigational Site | St Louis | Missouri | — | — |
| 248.616.063 Boehringer Ingelheim Investigational Site | St Louis | Missouri | — | — |
| 248.616.053 Boehringer Ingelheim Investigational Site | Dover | New Hampshire | — | — |
| 248.616.036 Boehringer Ingelheim Investigational Site | Albuquerque | New Mexico | — | — |
| 248.616.021 Boehringer Ingelheim Investigational Site | Albany | New York | — | — |
| 248.616.013 Boehringer Ingelheim Investigational Site | Cincinnati | Ohio | — | — |
| 248.616.003 Boehringer Ingelheim Investigational Site | Cleveland | Ohio | — | — |
| 248.616.068 Boehringer Ingelheim Investigational Site | Marion | Ohio | — | — |
| 248.616.012 Boehringer Ingelheim Investigational Site | Norman | Oklahoma | — | — |
| 248.616.006 Boehringer Ingelheim Investigational Site | Oklahoma City | Oklahoma | — | — |
| 248.616.019 Boehringer Ingelheim Investigational Site | Oklahoma City | Oklahoma | — | — |
| 248.616.069 Boehringer Ingelheim Investigational Site | Clarks Summit | Pennsylvania | — | — |
| 248.616.008 Boehringer Ingelheim Investigational Site | Columbia | South Carolina | — | — |
| 248.616.005 Boehringer Ingelheim Investigational Site | Dallas | Texas | — | — |
| 248.616.070 Boehringer Ingelheim Investigational Site | Rockwall | Texas | — | — |
| 248.616.039 Boehringer Ingelheim Investigational Site | San Marcos | Texas | — | — |
| 248.616.011 Boehringer Ingelheim Investigational Site | Alexandria | Virginia | — | — |
| 248.616.055 Boehringer Ingelheim Investigational Site | Norfolk | Virginia | — | — |
| 248.616.024 Boehringer Ingelheim Investigational Site | Milwaukee | Wisconsin | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00375284, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 31, 2013 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00375284 live on ClinicalTrials.gov.