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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pramipexole | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the total score of RLSRS (Restless Legs Syndrome rating scale for severity) of the IRLSSG (International Restless Legs Syndrome Study Group) | week 12 | |
| CGI-I (CGI-Improvement) | week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| RLSRS response (≥50% reduction from baseline in RLSRS) | at week 4, 6 and 12 | |
| CGI-I responder analysis | at week 4, 6 and 12 | |
| Change from baseline in CGI-Severity |
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim Study Coordinator | B.I. Pharmaceuticals,Inc./Ridgefield | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pivotal Research Centers | Peoria | Arizona | 85381 | United States | ||
| Mayo Clinic - Scottsdale |
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| at week 4, 6 and 12 |
| CGI-therapeutic effect | at week 4, 6 and 12 |
| CGI-Side effects | at week 4, 6 and 12 |
| Patient Global Impression (PGI) | at week 1-4, 6 and 12 |
| Visual analogue scales to assess RLS severity before sleep onset, during night and during day, and satisfaction with sleep | at week 4, 6 and 12 |
| Change from baseline in Epworth sleepiness scale (ESS) | at week 4, 6 and 12 |
| Change from baseline in RLS-QOL (Johns Hopkins Restless Legs Syndrome Quality of Life questionnaire) | at week 6 and 12 |
| Change from baseline in Augmentation Severity Rating Scale of IRLSSG | at week 6 and 12 |
| Change in systolic and diastolic blood pressure (after 5 minutes supine and subsequently after 1 minute standing) | week 12 |
| Change in pulse rate (palpation after 5 minute supine and subsequent after 1 minute standing) | week 12 |
| Change in routine laboratory tests | week 12 |
| Change in Physical examinations including eye examinations with ophthalmoscopic retinal eye examinations and a full skin dermatologic examination | week 12 |
| Change in Electrocardiogram | 12 weeks |
| Incidence of Adverse evens (including withdrawal symptoms and rebound symptoms) | up to 93 days |
| Concomitant medication reporting | 12 weeks |
| Early withdrawal phenomena | 12 weeks |
| Assessment of sudden onset of sleep (SOOS) | up to 93 days |
| Scottsdale |
| Arizona |
| 85259 |
| United States |
| Boehringer Ingelheim Investigational Site | Fountain Valley | California | 92708 | United States |
| HealthQuest Clinical Trials Research | San Diego | California | 92123 | United States |
| Stanford Sleep Clinic | Stanford | California | 94305-5730 | United States |
| Adult CF Center | Denver | Colorado | 80206 | United States |
| University of Colorado Health Sciences Center | Denver | Colorado | 80262 | United States |
| CNI Movement Disorders Center | Englewood | Colorado | 80113 | United States |
| George Washington University Medical Faculty Associates | Washington D.C. | District of Columbia | 20037 | United States |
| PAB Clinical Research | Brandon | Florida | 33511 | United States |
| Broward Research Group | Pembroke Pines | Florida | 33026-1956 | United States |
| Clinical Research Group of St Petersburg | St. Petersburg | Florida | 33707 | United States |
| Cleveland Clinic Florida- Department of Neurology | Weston | Florida | 33331 | United States |
| 5671 Peachtree Dunwoody Road | Atlanta | Georgia | 30342 | United States |
| Atlanta Pulmonary Group, LLC | Atlanta | Georgia | 30342 | United States |
| Movement Disorders Clinic | Augusta | Georgia | 30912 | United States |
| Sleepmed, Inc | Macon | Georgia | 31201 | United States |
| University of Iowa Health Care | Iowa City | Iowa | 52242-1053 | United States |
| Mid America NeuroScience Institute | Lenexa | Kansas | 66214 | United States |
| Boehringer Ingelheim Investigational Site | Baton Rouge | Louisiana | 70808 | United States |
| Center for Sleep and Wake Disorders | Chevy Chase | Maryland | 20815 | United States |
| 170 Thomas Johnson Dr, Suite 100 | Frederick | Maryland | 21702 | United States |
| Sleep Health Centers | Newton Center | Massachusetts | 02459 | United States |
| Henry Ford Hospital - Sleep Disorders and Research Center | Detroit | Michigan | 48202 | United States |
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | United States |
| Sleep Disorders Center | Jackson | Mississippi | 39216 | United States |
| Sleep Medicine Center | St Louis | Missouri | 63108 | United States |
| Lovelace Scientific Resources | Albuquerque | New Mexico | 87108 | United States |
| Winthrop Sleep Disorders Center | Mineola | New York | 11501 | United States |
| 932 Morreene Road #264 | Durham | North Carolina | 27705 | United States |
| Raleigh Neurology Associates | Raleigh | North Carolina | 27607 | United States |
| Wilmington Health Associates | Wilmington | North Carolina | 28401 | United States |
| Attn: Dr. David Mayleben | Cincinnati | Ohio | 45219 | United States |
| Metrohealth Medical Center | Cleveland | Ohio | 44109 | United States |
| Ohio Sleep Medicine Institute | Dublin | Ohio | 43017 | United States |
| Attn: Controller/Grants & Contracts Accounting | Oklahoma City | Oklahoma | 73190-3046 | United States |
| Center For Sleep Medicine | Lafayette Hill | Pennsylvania | 19444 | United States |
| The Arthritis Group | Philadelphia | Pennsylvania | 19152 | United States |
| Boehringer Ingelheim Investigational Site | Columbia | South Carolina | 29201 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Sleep Associates | Plano | Texas | 75093 | United States |
| 1500 N. Bearegard St, #300 | Alexandria | Virginia | 22311 | United States |
| Lynchburg Pulmonary Associates, Inc. | Lynchburg | Virginia | 24501 | United States |
| Eastern Virginia Medical School | Norfolk | Virginia | 23507 | United States |
| ID | Term |
|---|---|
| D012148 | Restless Legs Syndrome |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D020447 | Parasomnias |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077487 | Pramipexole |
| ID | Term |
|---|---|
| D052160 | Benzothiazoles |
| D013844 | Thiazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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