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NCT00133198 Clinical Trial

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

Restless Legs Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00133198
Other study ID # 248.543
Secondary ID
Status Completed
Phase Phase 3
First received August 22, 2005
Last updated November 7, 2013
Start date April 2004
Est. completion date February 2005

Study information
Verified date November 2013
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 345
Est. completion date February 2005
Est. primary completion date February 2005
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Pramipexole

Locations
Country Name City State
United States Lovelace Scientific Resources Albuquerque New Mexico
United States 1500 N. Bearegard St, #300 Alexandria Virginia
United States 5671 Peachtree Dunwoody Road Atlanta Georgia
United States Atlanta Pulmonary Group, LLC Atlanta Georgia
United States Movement Disorders Clinic Augusta Georgia
United States Boehringer Ingelheim Investigational Site Baton Rouge Louisiana
United States PAB Clinical Research Brandon Florida
United States Center for Sleep and Wake Disorders Chevy Chase Maryland
United States Attn: Dr. David Mayleben Cincinnati Ohio
United States Metrohealth Medical Center Cleveland Ohio
United States Boehringer Ingelheim Investigational Site Columbia South Carolina
United States Adult CF Center Denver Colorado
United States University of Colorado Health Sciences Center Denver Colorado
United States Henry Ford Hospital - Sleep Disorders and Research Center Detroit Michigan
United States Ohio Sleep Medicine Institute Dublin Ohio
United States 932 Morreene Road #264 Durham North Carolina
United States CNI Movement Disorders Center Englewood Colorado
United States Boehringer Ingelheim Investigational Site Fountain Valley California
United States 170 Thomas Johnson Dr, Suite 100 Frederick Maryland
United States Baylor College of Medicine Houston Texas
United States University of Iowa Health Care Iowa City Iowa
United States Sleep Disorders Center Jackson Mississippi
United States Center For Sleep Medicine Lafayette Hill Pennsylvania
United States Mid America NeuroScience Institute Lenexa Kansas
United States Lynchburg Pulmonary Associates, Inc. Lynchburg Virginia
United States Sleepmed, Inc Macon Georgia
United States Winthrop Sleep Disorders Center Mineola New York
United States Hennepin County Medical Center Minneapolis Minnesota
United States Sleep Health Centers Newton Center Massachusetts
United States Eastern Virginia Medical School Norfolk Virginia
United States Attn: Controller/Grants & Contracts Accounting Oklahoma City Oklahoma
United States Broward Research Group Pembroke Pines Florida
United States Pivotal Research Centers Peoria Arizona
United States The Arthritis Group Philadelphia Pennsylvania
United States Sleep Associates Plano Texas
United States Raleigh Neurology Associates Raleigh North Carolina
United States HealthQuest Clinical Trials Research San Diego California
United States Mayo Clinic - Scottsdale Scottsdale Arizona
United States Sleep Medicine Center St.Louis Missouri
United States Clinical Research Group of St Petersburg St.Petersburg Florida
United States Stanford Sleep Clinic Stanford California
United States George Washington University Medical Faculty Associates Washington District of Columbia
United States Cleveland Clinic Florida- Department of Neurology Weston Florida
United States Wilmington Health Associates Wilmington North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Primary CGI-I (CGI-Improvement) week 12 No
Secondary RLSRS response (=50% reduction from baseline in RLSRS) at week 4, 6 and 12 No
Secondary CGI-I responder analysis at week 4, 6 and 12 No
Secondary Change from baseline in CGI-Severity at week 4, 6 and 12 No
Secondary CGI-therapeutic effect at week 4, 6 and 12 No
Secondary CGI-Side effects at week 4, 6 and 12 No
Secondary Patient Global Impression (PGI) at week 1-4, 6 and 12 No
Secondary 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 No
Secondary Change from baseline in Epworth sleepiness scale (ESS) at week 4, 6 and 12 No
Secondary Change from baseline in RLS-QOL (Johns Hopkins Restless Legs Syndrome Quality of Life questionnaire) at week 6 and 12 No
Secondary Change from baseline in Augmentation Severity Rating Scale of IRLSSG at week 6 and 12 No
Secondary Change in systolic and diastolic blood pressure (after 5 minutes supine and subsequently after 1 minute standing) week 12 No
Secondary Change in pulse rate (palpation after 5 minute supine and subsequent after 1 minute standing) week 12 No
Secondary Change in routine laboratory tests week 12 No
Secondary Change in Physical examinations including eye examinations with ophthalmoscopic retinal eye examinations and a full skin dermatologic examination week 12 No
Secondary Change in Electrocardiogram 12 weeks No
Secondary Incidence of Adverse evens (including withdrawal symptoms and rebound symptoms) up to 93 days No
Secondary Concomitant medication reporting 12 weeks No
Secondary Early withdrawal phenomena 12 weeks No
Secondary Assessment of sudden onset of sleep (SOOS) up to 93 days No
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  Status Clinical Trial Phase
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Completed NCT00530530 - ASP8825 - Study in Patients With Restless Legs Syndrome Phase 2
Completed NCT00721279 - Sifrol (Pramipexole) Onset of Action and Impact: a 12-weeks Observational Study in Patients With Primary Restless Legs Syndrome N/A
Completed NCT00942253 - Exercise Training in Dialysis Patients With Restless Legs Syndrome (RLS) Phase 2
Completed NCT00375284 - A 6 Week Trial to Study the Efficacy and Safety of a Starting Dose 0.25 mg Pramipexole (Mirapex) in Patients With RLS Phase 4
Completed NCT00479531 - Sequential Compression Devices for Treatment of Restless Legs Syndrome Phase 3
Recruiting NCT05581576 - Pitolisant in Refractory Restless Legs Syndrome Phase 4
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Recruiting NCT05044520 - Clinical Features Associated With Restless Legs Syndrome.
Withdrawn NCT03849001 - Impact of Acute Leg Cycling at Various Intensities on RLS Severity in Persons With MS N/A
Completed NCT03076541 - Cardiovascular Variability, Heart Rate Response, and Electromyogram Power Associated With Periodic Leg Movements. N/A
Recruiting NCT04145674 - A Proof of Concept, Phase 2, Double-blind, Randomized Trial With d-Methadone Product Versus Placebo Phase 2
Completed NCT02532608 - Infra-slow Oscillations During Sleep N/A
Completed NCT01528462 - Sleep Disorders Managed and Assessed Rapidly in Transient Ischemic Attack (TIA) and In Early Stroke
Completed NCT00748098 - Polysomnography Study of GSK1838262 Extended Release Tablets Versus Placebo in RLS and Associated Sleep Disturbance Phase 3

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