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

Primary Purpose

Restless Legs Syndrome

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Pramipexole
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Restless Legs Syndrome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Sites / Locations

  • Pivotal Research Centers
  • Mayo Clinic - Scottsdale
  • Boehringer Ingelheim Investigational Site
  • HealthQuest Clinical Trials Research
  • Stanford Sleep Clinic
  • Adult CF Center
  • University of Colorado Health Sciences Center
  • CNI Movement Disorders Center
  • George Washington University Medical Faculty Associates
  • PAB Clinical Research
  • Broward Research Group
  • Clinical Research Group of St Petersburg
  • Cleveland Clinic Florida- Department of Neurology
  • 5671 Peachtree Dunwoody Road
  • Atlanta Pulmonary Group, LLC
  • Movement Disorders Clinic
  • Sleepmed, Inc
  • University of Iowa Health Care
  • Mid America NeuroScience Institute
  • Boehringer Ingelheim Investigational Site
  • Center for Sleep and Wake Disorders
  • 170 Thomas Johnson Dr, Suite 100
  • Sleep Health Centers
  • Henry Ford Hospital - Sleep Disorders and Research Center
  • Hennepin County Medical Center
  • Sleep Disorders Center
  • Sleep Medicine Center
  • Lovelace Scientific Resources
  • Winthrop Sleep Disorders Center
  • 932 Morreene Road #264
  • Raleigh Neurology Associates
  • Wilmington Health Associates
  • Attn: Dr. David Mayleben
  • Metrohealth Medical Center
  • Ohio Sleep Medicine Institute
  • Attn: Controller/Grants & Contracts Accounting
  • Center For Sleep Medicine
  • The Arthritis Group
  • Boehringer Ingelheim Investigational Site
  • Baylor College of Medicine
  • Sleep Associates
  • 1500 N. Bearegard St, #300
  • Lynchburg Pulmonary Associates, Inc.
  • Eastern Virginia Medical School

Outcomes

Primary Outcome Measures

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)
CGI-I (CGI-Improvement)

Secondary Outcome Measures

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

Full Information

First Posted
August 22, 2005
Last Updated
November 7, 2013
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00133198
Brief Title
Efficacy and Safety of Pramipexole Compared to Placebo in the Treatment of Restless Legs Syndrome (RLS)
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 Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
February 2005 (Actual)
Study Completion Date
February 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Restless Legs Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
345 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim Study Coordinator
Organizational Affiliation
B.I. Pharmaceuticals,Inc./Ridgefield
Official's Role
Study Chair
Facility Information:
Facility Name
Pivotal Research Centers
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Mayo Clinic - Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
HealthQuest Clinical Trials Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Stanford Sleep Clinic
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5730
Country
United States
Facility Name
Adult CF Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
University of Colorado Health Sciences Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
CNI Movement Disorders Center
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
George Washington University Medical Faculty Associates
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
PAB Clinical Research
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Broward Research Group
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33026-1956
Country
United States
Facility Name
Clinical Research Group of St Petersburg
City
St.Petersburg
State/Province
Florida
ZIP/Postal Code
33707
Country
United States
Facility Name
Cleveland Clinic Florida- Department of Neurology
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
5671 Peachtree Dunwoody Road
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Atlanta Pulmonary Group, LLC
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Movement Disorders Clinic
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Sleepmed, Inc
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
University of Iowa Health Care
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1053
Country
United States
Facility Name
Mid America NeuroScience Institute
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66214
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Center for Sleep and Wake Disorders
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
170 Thomas Johnson Dr, Suite 100
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21702
Country
United States
Facility Name
Sleep Health Centers
City
Newton Center
State/Province
Massachusetts
ZIP/Postal Code
02459
Country
United States
Facility Name
Henry Ford Hospital - Sleep Disorders and Research Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
Sleep Disorders Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Sleep Medicine Center
City
St.Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Lovelace Scientific Resources
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Facility Name
Winthrop Sleep Disorders Center
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
932 Morreene Road #264
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Raleigh Neurology Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Wilmington Health Associates
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Attn: Dr. David Mayleben
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Metrohealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Ohio Sleep Medicine Institute
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43017
Country
United States
Facility Name
Attn: Controller/Grants & Contracts Accounting
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73190-3046
Country
United States
Facility Name
Center For Sleep Medicine
City
Lafayette Hill
State/Province
Pennsylvania
ZIP/Postal Code
19444
Country
United States
Facility Name
The Arthritis Group
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19152
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Sleep Associates
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
1500 N. Bearegard St, #300
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22311
Country
United States
Facility Name
Lynchburg Pulmonary Associates, Inc.
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
Facility Name
Eastern Virginia Medical School
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/248/248.543_U05-3094.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/248/248.543_literature.pdf
Description
Related Info

Learn more about this trial

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

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