Clinical trial NCT00133198: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Restless Legs Syndrome
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2005-08-23
Enrollment: 345
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.



Primary outcomes:
measure: 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)
timeFrame: week 12
measure: CGI-I (CGI-Improvement)
timeFrame: week 12
Secondary outcomes:
measure: RLSRS response (≥50% reduction from baseline in RLSRS)
timeFrame: at week 4, 6 and 12
measure: CGI-I responder analysis
timeFrame: at week 4, 6 and 12
measure: Change from baseline in CGI-Severity
timeFrame: at week 4, 6 and 12
measure: CGI-therapeutic effect
timeFrame: at week 4, 6 and 12
measure: CGI-Side effects
timeFrame: at week 4, 6 and 12
measure: Patient Global Impression (PGI)
timeFrame: at week 1-4, 6 and 12
measure: Visual analogue scales to assess RLS severity before sleep onset, during night and during day, and satisfaction with sleep
timeFrame: at week 4, 6 and 12
measure: Change from baseline in Epworth sleepiness scale (ESS)
timeFrame: at week 4, 6 and 12
measure: Change from baseline in RLS-QOL (Johns Hopkins Restless Legs Syndrome Quality of Life questionnaire)
timeFrame: at week 6 and 12
measure: Change from baseline in Augmentation Severity Rating Scale of IRLSSG
timeFrame: at week 6 and 12
measure: Change in systolic and diastolic blood pressure (after 5 minutes supine and subsequently after 1 minute standing)
timeFrame: week 12
measure: Change in pulse rate (palpation after 5 minute supine and subsequent after 1 minute standing)
timeFrame: week 12
measure: Change in routine laboratory tests
timeFrame: week 12
measure: Change in Physical examinations including eye examinations with ophthalmoscopic retinal eye examinations and a full skin dermatologic examination
timeFrame: week 12
measure: Change in Electrocardiogram
timeFrame: 12 weeks
measure: Incidence of Adverse evens (including withdrawal symptoms and rebound symptoms)
timeFrame: up to 93 days
measure: Concomitant medication reporting
timeFrame: 12 weeks
measure: Early withdrawal phenomena
timeFrame: 12 weeks
measure: Assessment of sudden onset of sleep (SOOS)
timeFrame: up to 93 days
Other outcomes:
Locations:
city: Peoria
country: United States
facility: Pivotal Research Centers
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Clinic - Scottsdale
state: Arizona
city: Fountain Valley
country: United States
facility: Boehringer Ingelheim Investigational Site
state: California
city: San Diego
country: United States
facility: HealthQuest Clinical Trials Research
state: California
city: Stanford
country: United States
facility: Stanford Sleep Clinic
state: California
city: Denver
country: United States
facility: Adult CF Center
state: Colorado
city: Denver
country: United States
facility: University of Colorado Health Sciences Center
state: Colorado
city: Englewood
country: United States
facility: CNI Movement Disorders Center
state: Colorado
city: Washington
country: United States
facility: George Washington University Medical Faculty Associates
state: District of Columbia
city: Brandon
country: United States
facility: PAB Clinical Research
state: Florida
city: Pembroke Pines
country: United States
facility: Broward Research Group
state: Florida
city: St.Petersburg
country: United States
facility: Clinical Research Group of St Petersburg
state: Florida
city: Weston
country: United States
facility: Cleveland Clinic Florida- Department of Neurology
state: Florida
city: Atlanta
country: United States
facility: 5671 Peachtree Dunwoody Road
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Pulmonary Group, LLC
state: Georgia
city: Augusta
country: United States
facility: Movement Disorders Clinic
state: Georgia
city: Macon
country: United States
facility: Sleepmed, Inc
state: Georgia
city: Iowa City
country: United States
facility: University of Iowa Health Care
state: Iowa
city: Lenexa
country: United States
facility: Mid America NeuroScience Institute
state: Kansas
city: Baton Rouge
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Louisiana
city: Chevy Chase
country: United States
facility: Center for Sleep and Wake Disorders
state: Maryland
city: Frederick
country: United States
facility: 170 Thomas Johnson Dr, Suite 100
state: Maryland
city: Newton Center
country: United States
facility: Sleep Health Centers
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital - Sleep Disorders and Research Center
state: Michigan
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Jackson
country: United States
facility: Sleep Disorders Center
state: Mississippi
city: St.Louis
country: United States
facility: Sleep Medicine Center
state: Missouri
city: Albuquerque
country: United States
facility: Lovelace Scientific Resources
state: New Mexico
city: Mineola
country: United States
facility: Winthrop Sleep Disorders Center
state: New York
city: Durham
country: United States
facility: 932 Morreene Road #264
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Neurology Associates
state: North Carolina
city: Wilmington
country: United States
facility: Wilmington Health Associates
state: North Carolina
city: Cincinnati
country: United States
facility: Attn: Dr. David Mayleben
state: Ohio
city: Cleveland
country: United States
facility: Metrohealth Medical Center
state: Ohio
city: Dublin
country: United States
facility: Ohio Sleep Medicine Institute
state: Ohio
city: Oklahoma City
country: United States
facility: Attn: Controller/Grants & Contracts Accounting
state: Oklahoma
city: Lafayette Hill
country: United States
facility: Center For Sleep Medicine
state: Pennsylvania
city: Philadelphia
country: United States
facility: The Arthritis Group
state: Pennsylvania
city: Columbia
country: United States
facility: Boehringer Ingelheim Investigational Site
state: South Carolina
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Plano
country: United States
facility: Sleep Associates
state: Texas
city: Alexandria
country: United States
facility: 1500 N. Bearegard St, #300
state: Virginia
city: Lynchburg
country: United States
facility: Lynchburg Pulmonary Associates, Inc.
state: Virginia
city: Norfolk
country: United States
facility: Eastern Virginia Medical School
state: Virginia
Study officials:
affiliation: B.I. Pharmaceuticals,Inc./Ridgefield
name: Boehringer Ingelheim Study Coordinator
role: STUDY_CHAIR
References: