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

November 7, 2013 updated by: Boehringer Ingelheim

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

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.

Study Overview

Status

Completed

Conditions

Restless Legs Syndrome

Intervention / Treatment

Drug: Pramipexole

Study Type

Interventional

Enrollment (Actual)

345

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Arizona
  - Peoria, Arizona, United States, 85381
    - Pivotal Research Centers
  - Scottsdale, Arizona, United States, 85259
    - Mayo Clinic - Scottsdale
- California
  - Fountain Valley, California, United States, 92708
    - Boehringer Ingelheim Investigational Site
  - San Diego, California, United States, 92123
    - HealthQuest Clinical Trials Research
  - Stanford, California, United States, 94305-5730
    - Stanford Sleep Clinic
- Colorado
  - Denver, Colorado, United States, 80262
    - University of Colorado Health Sciences Center
  - Denver, Colorado, United States, 80206
    - Adult CF Center
  - Englewood, Colorado, United States, 80113
    - CNI Movement Disorders Center
- District of Columbia
  - Washington, District of Columbia, United States, 20037
    - George Washington University Medical Faculty Associates
- Florida
  - Brandon, Florida, United States, 33511
    - PAB Clinical Research
  - Pembroke Pines, Florida, United States, 33026-1956
    - Broward Research Group
  - St.Petersburg, Florida, United States, 33707
    - Clinical Research Group of St Petersburg
  - Weston, Florida, United States, 33331
    - Cleveland Clinic Florida- Department of Neurology
- Georgia
  - Atlanta, Georgia, United States, 30342
    - 5671 Peachtree Dunwoody Road
  - Atlanta, Georgia, United States, 30342
    - Atlanta Pulmonary Group, LLC
  - Augusta, Georgia, United States, 30912
    - Movement Disorders Clinic
  - Macon, Georgia, United States, 31201
    - SleepMed, Inc
- Iowa
  - Iowa City, Iowa, United States, 52242-1053
    - University of Iowa Health Care
- Kansas
  - Lenexa, Kansas, United States, 66214
    - Mid America Neuroscience Institute
- Louisiana
  - Baton Rouge, Louisiana, United States, 70808
    - Boehringer Ingelheim Investigational Site
- Maryland
  - Chevy Chase, Maryland, United States, 20815
    - Center For Sleep and Wake Disorders
  - Frederick, Maryland, United States, 21702
    - 170 Thomas Johnson Dr, Suite 100
- Massachusetts
  - Newton Center, Massachusetts, United States, 02459
    - Sleep Health Centers
- Michigan
  - Detroit, Michigan, United States, 48202
    - Henry Ford Hospital - Sleep Disorders and Research Center
- Minnesota
  - Minneapolis, Minnesota, United States, 55415
    - Hennepin County Medical Center
- Mississippi
  - Jackson, Mississippi, United States, 39216
    - Sleep Disorders Center
- Missouri
  - St.Louis, Missouri, United States, 63108
    - Sleep Medicine Center
- New Mexico
  - Albuquerque, New Mexico, United States, 87108
    - Lovelace Scientific Resources
- New York
  - Mineola, New York, United States, 11501
    - Winthrop Sleep Disorders Center
- North Carolina
  - Durham, North Carolina, United States, 27705
    - 932 Morreene Road #264
  - Raleigh, North Carolina, United States, 27607
    - Raleigh Neurology Associates
  - Wilmington, North Carolina, United States, 28401
    - Wilmington Health Associates
- Ohio
  - Cincinnati, Ohio, United States, 45219
    - Attn: Dr. David Mayleben
  - Cleveland, Ohio, United States, 44109
    - MetroHealth Medical Center
  - Dublin, Ohio, United States, 43017
    - Ohio Sleep Medicine Institute
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73190-3046
    - Attn: Controller/Grants & Contracts Accounting
- Pennsylvania
  - Lafayette Hill, Pennsylvania, United States, 19444
    - Center for Sleep Medicine
  - Philadelphia, Pennsylvania, United States, 19152
    - The Arthritis Group
- South Carolina
  - Columbia, South Carolina, United States, 29201
    - Boehringer Ingelheim Investigational Site
- Texas
  - Houston, Texas, United States, 77030
    - Baylor College of Medicine
  - Plano, Texas, United States, 75093
    - Sleep Associates
- Virginia
  - Alexandria, Virginia, United States, 22311
    - 1500 N. Bearegard St, #300
  - Lynchburg, Virginia, United States, 24501
    - Lynchburg Pulmonary Associates, Inc.
  - Norfolk, Virginia, United States, 23507
    - Eastern Virginia Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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) Time Frame: week 12	week 12
CGI-I (CGI-Improvement) Time Frame: week 12	week 12

Secondary Outcome Measures

Outcome Measure	Time Frame
RLSRS response (≥50% reduction from baseline in RLSRS) Time Frame: at week 4, 6 and 12	at week 4, 6 and 12
CGI-I responder analysis Time Frame: at week 4, 6 and 12	at week 4, 6 and 12
Change from baseline in CGI-Severity Time Frame: at week 4, 6 and 12	at week 4, 6 and 12
CGI-therapeutic effect Time Frame: at week 4, 6 and 12	at week 4, 6 and 12
CGI-Side effects Time Frame: at week 4, 6 and 12	at week 4, 6 and 12
Patient Global Impression (PGI) Time Frame: at week 1-4, 6 and 12	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 Time Frame: at week 4, 6 and 12	at week 4, 6 and 12
Change from baseline in Epworth sleepiness scale (ESS) Time Frame: at week 4, 6 and 12	at week 4, 6 and 12
Change from baseline in RLS-QOL (Johns Hopkins Restless Legs Syndrome Quality of Life questionnaire) Time Frame: at week 6 and 12	at week 6 and 12
Change from baseline in Augmentation Severity Rating Scale of IRLSSG Time Frame: at week 6 and 12	at week 6 and 12
Change in systolic and diastolic blood pressure (after 5 minutes supine and subsequently after 1 minute standing) Time Frame: week 12	week 12
Change in pulse rate (palpation after 5 minute supine and subsequent after 1 minute standing) Time Frame: week 12	week 12
Change in routine laboratory tests Time Frame: week 12	week 12
Change in Physical examinations including eye examinations with ophthalmoscopic retinal eye examinations and a full skin dermatologic examination Time Frame: week 12	week 12
Change in Electrocardiogram Time Frame: 12 weeks	12 weeks
Incidence of Adverse evens (including withdrawal symptoms and rebound symptoms) Time Frame: up to 93 days	up to 93 days
Concomitant medication reporting Time Frame: 12 weeks	12 weeks
Early withdrawal phenomena Time Frame: 12 weeks	12 weeks
Assessment of sudden onset of sleep (SOOS) Time Frame: up to 93 days	up to 93 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (Actual)

February 1, 2005

Study Completion