Clincosm LogoSign in Get a demo

Efficacy and Safety of Pramipexole Compared to Placebo in the Treatment of Restless Legs Syndrome (RLS)

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT00133198
Collaborator
(none)
345
Enrollment
44
Locations
10.1
Duration (Months)
7.8
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
345 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
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 Start Date :
Apr 1, 2004
Actual Primary Completion Date :
Feb 1, 2005
Study Completion Date :
Feb 1, 2005

Outcome Measures

Primary Outcome Measures

  1. 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]

  2. CGI-I (CGI-Improvement) [week 12]

Secondary Outcome Measures

  1. RLSRS response (≥50% reduction from baseline in RLSRS) [at week 4, 6 and 12]

  2. CGI-I responder analysis [at week 4, 6 and 12]

  3. Change from baseline in CGI-Severity [at week 4, 6 and 12]

  4. CGI-therapeutic effect [at week 4, 6 and 12]

  5. CGI-Side effects [at week 4, 6 and 12]

  6. Patient Global Impression (PGI) [at week 1-4, 6 and 12]

  7. 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]

  8. Change from baseline in Epworth sleepiness scale (ESS) [at week 4, 6 and 12]

  9. Change from baseline in RLS-QOL (Johns Hopkins Restless Legs Syndrome Quality of Life questionnaire) [at week 6 and 12]

  10. Change from baseline in Augmentation Severity Rating Scale of IRLSSG [at week 6 and 12]

  11. Change in systolic and diastolic blood pressure (after 5 minutes supine and subsequently after 1 minute standing) [week 12]

  12. Change in pulse rate (palpation after 5 minute supine and subsequent after 1 minute standing) [week 12]

  13. Change in routine laboratory tests [week 12]

  14. Change in Physical examinations including eye examinations with ophthalmoscopic retinal eye examinations and a full skin dermatologic examination [week 12]

  15. Change in Electrocardiogram [12 weeks]

  16. Incidence of Adverse evens (including withdrawal symptoms and rebound symptoms) [up to 93 days]

  17. Concomitant medication reporting [12 weeks]

  18. Early withdrawal phenomena [12 weeks]

  19. Assessment of sudden onset of sleep (SOOS) [up to 93 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pivotal Research Centers Peoria Arizona United States 85381
2 Mayo Clinic - Scottsdale Scottsdale Arizona United States 85259
3 Boehringer Ingelheim Investigational Site Fountain Valley California United States 92708
4 HealthQuest Clinical Trials Research San Diego California United States 92123
5 Stanford Sleep Clinic Stanford California United States 94305-5730
6 Adult CF Center Denver Colorado United States 80206
7 University of Colorado Health Sciences Center Denver Colorado United States 80262
8 CNI Movement Disorders Center Englewood Colorado United States 80113
9 George Washington University Medical Faculty Associates Washington District of Columbia United States 20037
10 PAB Clinical Research Brandon Florida United States 33511
11 Broward Research Group Pembroke Pines Florida United States 33026-1956
12 Clinical Research Group of St Petersburg St.Petersburg Florida United States 33707
13 Cleveland Clinic Florida- Department of Neurology Weston Florida United States 33331
14 5671 Peachtree Dunwoody Road Atlanta Georgia United States 30342
15 Atlanta Pulmonary Group, LLC Atlanta Georgia United States 30342
16 Movement Disorders Clinic Augusta Georgia United States 30912
17 Sleepmed, Inc Macon Georgia United States 31201
18 University of Iowa Health Care Iowa City Iowa United States 52242-1053
19 Mid America NeuroScience Institute Lenexa Kansas United States 66214
20 Boehringer Ingelheim Investigational Site Baton Rouge Louisiana United States 70808
21 Center for Sleep and Wake Disorders Chevy Chase Maryland United States 20815
22 170 Thomas Johnson Dr, Suite 100 Frederick Maryland United States 21702
23 Sleep Health Centers Newton Center Massachusetts United States 02459
24 Henry Ford Hospital - Sleep Disorders and Research Center Detroit Michigan United States 48202
25 Hennepin County Medical Center Minneapolis Minnesota United States 55415
26 Sleep Disorders Center Jackson Mississippi United States 39216
27 Sleep Medicine Center St.Louis Missouri United States 63108
28 Lovelace Scientific Resources Albuquerque New Mexico United States 87108
29 Winthrop Sleep Disorders Center Mineola New York United States 11501
30 932 Morreene Road #264 Durham North Carolina United States 27705
31 Raleigh Neurology Associates Raleigh North Carolina United States 27607
32 Wilmington Health Associates Wilmington North Carolina United States 28401
33 Attn: Dr. David Mayleben Cincinnati Ohio United States 45219
34 Metrohealth Medical Center Cleveland Ohio United States 44109
35 Ohio Sleep Medicine Institute Dublin Ohio United States 43017
36 Attn: Controller/Grants & Contracts Accounting Oklahoma City Oklahoma United States 73190-3046
37 Center For Sleep Medicine Lafayette Hill Pennsylvania United States 19444
38 The Arthritis Group Philadelphia Pennsylvania United States 19152
39 Boehringer Ingelheim Investigational Site Columbia South Carolina United States 29201
40 Baylor College of Medicine Houston Texas United States 77030
41 Sleep Associates Plano Texas United States 75093
42 1500 N. Bearegard St, #300 Alexandria Virginia United States 22311
43 Lynchburg Pulmonary Associates, Inc. Lynchburg Virginia United States 24501
44 Eastern Virginia Medical School Norfolk Virginia United States 23507

Sponsors and Collaborators

  • Boehringer Ingelheim

Investigators

  • Study Chair: Boehringer Ingelheim Study Coordinator, B.I. Pharmaceuticals,Inc./Ridgefield

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00133198
Other Study ID Numbers:
  • 248.543
First Posted:
Aug 23, 2005
Last Update Posted:
Nov 8, 2013
Last Verified:
Nov 1, 2013
Additional relevant MeSH terms:
Psychomotor Agitation
Restless Legs Syndrome
Syndrome
Pramipexole

Study Results

No Results Posted as of Nov 8, 2013