Efficacy and Safety of Pramipexole Compared to Placebo in the Treatment of Restless Legs Syndrome (RLS)
Public ClinicalTrials.gov record NCT00133198. 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 Randomized, Double-blind, Placebo-controlled, Parallel Group Clinical Trial Comparing Fixed Doses of 0.25 mg, 0.50 mg and 0.75 mg Pramipexole (Mirapex®) Administered Orally to Investigate the Safety and Efficacy in Patients With Idiopathic Restless Legs Syndrome for 12 Weeks
Study identification
- NCT ID
- NCT00133198
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Boehringer Ingelheim
- Industry
- Enrollment
- 345 participants
Conditions and interventions
Conditions
Interventions
- Pramipexole Drug
Drug
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
- Mar 31, 2004
- Primary completion
- Jan 31, 2005
- Completion
- Jan 31, 2005
- Last update posted
- Nov 7, 2013
2004 – 2005
United States locations
- U.S. sites
- 44
- U.S. states
- 24
- U.S. cities
- 42
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pivotal Research Centers | Peoria | Arizona | 85381 | — |
| Mayo Clinic - Scottsdale | Scottsdale | Arizona | 85259 | — |
| Boehringer Ingelheim Investigational Site | Fountain Valley | California | 92708 | — |
| HealthQuest Clinical Trials Research | San Diego | California | 92123 | — |
| Stanford Sleep Clinic | Stanford | California | 94305-5730 | — |
| Adult CF Center | Denver | Colorado | 80206 | — |
| University of Colorado Health Sciences Center | Denver | Colorado | 80262 | — |
| CNI Movement Disorders Center | Englewood | Colorado | 80113 | — |
| George Washington University Medical Faculty Associates | Washington D.C. | District of Columbia | 20037 | — |
| PAB Clinical Research | Brandon | Florida | 33511 | — |
| Broward Research Group | Pembroke Pines | Florida | 33026-1956 | — |
| Clinical Research Group of St Petersburg | St. Petersburg | Florida | 33707 | — |
| Cleveland Clinic Florida- Department of Neurology | Weston | Florida | 33331 | — |
| 5671 Peachtree Dunwoody Road | Atlanta | Georgia | 30342 | — |
| Atlanta Pulmonary Group, LLC | Atlanta | Georgia | 30342 | — |
| Movement Disorders Clinic | Augusta | Georgia | 30912 | — |
| Sleepmed, Inc | Macon | Georgia | 31201 | — |
| University of Iowa Health Care | Iowa City | Iowa | 52242-1053 | — |
| Mid America NeuroScience Institute | Lenexa | Kansas | 66214 | — |
| Boehringer Ingelheim Investigational Site | Baton Rouge | Louisiana | 70808 | — |
| Center for Sleep and Wake Disorders | Chevy Chase | Maryland | 20815 | — |
| 170 Thomas Johnson Dr, Suite 100 | Frederick | Maryland | 21702 | — |
| Sleep Health Centers | Newton Center | Massachusetts | 02459 | — |
| Henry Ford Hospital - Sleep Disorders and Research Center | Detroit | Michigan | 48202 | — |
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | — |
| Sleep Disorders Center | Jackson | Mississippi | 39216 | — |
| Sleep Medicine Center | St Louis | Missouri | 63108 | — |
| Lovelace Scientific Resources | Albuquerque | New Mexico | 87108 | — |
| Winthrop Sleep Disorders Center | Mineola | New York | 11501 | — |
| 932 Morreene Road #264 | Durham | North Carolina | 27705 | — |
| Raleigh Neurology Associates | Raleigh | North Carolina | 27607 | — |
| Wilmington Health Associates | Wilmington | North Carolina | 28401 | — |
| Attn: Dr. David Mayleben | Cincinnati | Ohio | 45219 | — |
| Metrohealth Medical Center | Cleveland | Ohio | 44109 | — |
| Ohio Sleep Medicine Institute | Dublin | Ohio | 43017 | — |
| Attn: Controller/Grants & Contracts Accounting | Oklahoma City | Oklahoma | 73190-3046 | — |
| Center For Sleep Medicine | Lafayette Hill | Pennsylvania | 19444 | — |
| The Arthritis Group | Philadelphia | Pennsylvania | 19152 | — |
| Boehringer Ingelheim Investigational Site | Columbia | South Carolina | 29201 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| Sleep Associates | Plano | Texas | 75093 | — |
| 1500 N. Bearegard St, #300 | Alexandria | Virginia | 22311 | — |
| Lynchburg Pulmonary Associates, Inc. | Lynchburg | Virginia | 24501 | — |
| Eastern Virginia Medical School | Norfolk | Virginia | 23507 | — |
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 NCT00133198, 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 Nov 7, 2013 · Synced Jul 22, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00133198 live on ClinicalTrials.gov.