Clinical trial NCT00625547: A Study to Determine the Efficacy and Safety of Cabergoline for the Treatment of Patients With RLS
Official title: A Double-Blind, Randomized, Active-Controlled Multicenter Efficacy Trial for the Treatment of Patients With Restless Legs Syndrome (RLS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Restless Legs Syndrome
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-02-28
Enrollment: 361
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of cabergoline compared with levodopa in the treatment of patients with RLS.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of idiopathic RLS and had all 4 clinical manifestations of RLS
* Moderate to severe symptoms of RLS as indicated by an IRLSSG-RS total score greater than or equal to 10 and a severity at night score of greater than or equal to 4 on an 11-point RLS-6 rating scale
* No previous treatment for RLS or dissatisfaction with their current therapy

Exclusion Criteria:

* Not available

Primary outcomes:
measure: Change from baseline in the total score of the International RLS Study Group Rating Scale (IRLSSG-RS)
timeFrame: Week 6
measure: Time to dropout due to a necessary change in RLS therapy because of augmentation or loss of efficacy (e.g., dose increment of study drug, switch to another therapy, or start of a drug-free period)
Secondary outcomes:
measure: RLS quality-of-life questionnaire
timeFrame: Weeks 6 and 30
measure: Clinical Global Impression
timeFrame: Weeks 6 and 30
measure: Patient Global Impression
timeFrame: Weeks 6 and 30
measure: Sleep questionnaire form A
timeFrame: Weeks 6 and 30
measure: IRLSSG-RS
timeFrame: Week 30
measure: Safety evaluation including adverse events, clinically relevant changes in laboratory data, physical exam findings, and abnormalities observed in electrocardiogram
timeFrame: Weeks 2, 6, and 8 during Period 1 and every 4 weeks during Period 2
measure: Rating of severity of RLS at night (RLS-6 scale)
timeFrame: Weeks 6 and 30
measure: Rating of severity of RLS before bedtime (RLS-6 scale)
timeFrame: Weeks 6 and 30
measure: Rating of severity of RLS at day when at rest and during activities, severity of daytime sleepiness (RLS-6 scales)
timeFrame: Weeks 6 and 30
measure: Global rating of quality of sleep (RLS-6 scale)
timeFrame: Weeks 6 and 30
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Pfizer Investigational Site
city: Wien
country: Austria
facility: Pfizer Investigational Site
city: Altoetting
country: Germany
facility: Pfizer Investigational Site
city: Aschaffenburg
country: Germany
facility: Pfizer Investigational Site
city: Bad Honnef
country: Germany
facility: Pfizer Investigational Site
city: Bad Saarow
country: Germany
facility: Pfizer Investigational Site
city: Beckum
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Bochum
country: Germany
facility: Pfizer Investigational Site
city: Bremerhaven
country: Germany
facility: Pfizer Investigational Site
city: Dillingen
country: Germany
facility: Pfizer Investigational Site
city: Duesseldorf
country: Germany
facility: Pfizer Investigational Site
city: Duisburg
country: Germany
facility: Pfizer Investigational Site
city: Gelsenkirchen
country: Germany
facility: Pfizer Investigational Site
city: Gera
country: Germany
facility: Pfizer Investigational Site
city: Goettingen
country: Germany
facility: Pfizer Investigational Site
city: Goettingen
country: Germany
facility: Pfizer Investigational Site
city: Halle
country: Germany
facility: Pfizer Investigational Site
city: Hamburg
country: Germany
facility: Pfizer Investigational Site
city: Heilbronn
country: Germany
facility: Pfizer Investigational Site
city: Jena
country: Germany
facility: Pfizer Investigational Site
city: Kaiserslautern
country: Germany
facility: Pfizer Investigational Site
city: Karlsruhe
country: Germany
facility: Pfizer Investigational Site
city: Karlsruhe
country: Germany
facility: Pfizer Investigational Site
city: Kassel
country: Germany
facility: Pfizer Investigational Site
city: Köthen
country: Germany
facility: Pfizer Investigational Site
city: Marburg
country: Germany
facility: Pfizer Investigational Site
city: Mittweida
country: Germany
facility: Pfizer Investigational Site
city: Moenchengladbach
country: Germany
facility: Pfizer Investigational Site
city: Neubrandenburg
country: Germany
facility: Pfizer Investigational Site
city: Oldenburg
country: Germany
facility: Pfizer Investigational Site
city: Quickborn
country: Germany
facility: Pfizer Investigational Site
city: Regensburg
country: Germany
facility: Pfizer Investigational Site
city: Schwalmstadt
country: Germany
facility: Pfizer Investigational Site
city: Schwerin
country: Germany
facility: Pfizer Investigational Site
city: Stuttgart
country: Germany
facility: Pfizer Investigational Site
city: Tuttlingen
country: Germany
facility: Pfizer Investigational Site
city: Ulm
country: Germany
facility: Pfizer Investigational Site
city: Wiesbaden
country: Germany
facility: Pfizer Investigational Site
city: Wolfsburg
country: Germany
facility: Pfizer Investigational Site
city: Goteborg
country: Sweden
facility: Pfizer Investigational Site
city: Karlstad
country: Sweden
facility: Pfizer Investigational Site
city: Linköping
country: Sweden
facility: Pfizer Investigational Site
city: Basel
country: Switzerland
facility: Pfizer Investigational Site
city: Bern
country: Switzerland
facility: Pfizer Investigational Site
city: Zürich
country: Switzerland
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: