A Study to Determine the Efficacy and Safety of Cabergoline for the Treatment of Patients With RLS

Pfizer361 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

361

Conditions

Restless Legs Syndrome

Interventions

cabergolineDRUG

Cabergoline oral tablets: 0.5 mg daily on Days 1 to 3, 1.0 mg daily on Days 4 to 7, 1.5 mg daily on Days 8 to 10, and 2.0 mg daily on Days 11 to 14 and then administered as a stable dose for a further 4 weeks; at Week 6, dose could be increased to 3 mg daily if patient experienced insufficient efficacy without impairing adverse events

levodopaDRUG

Levodopa oral capsules: 25 mg twice daily on Days 1 to 3, 50 mg twice daily on Days 4 to 7, 100 mg twice daily on Days 8 to 14 and then administered as a stable dose for a further 4 weeks; at Week 6, dose could be increased to 150 mg twice daily if patient experienced insufficient efficacy without impairing adverse events

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (50)

Outcomes

Primary Outcomes

Change from baseline in the total score of the International RLS Study Group Rating Scale (IRLSSG-RS)

Time frame: Week 6

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

RLS quality-of-life questionnaire

Time frame: Weeks 6 and 30

Clinical Global Impression

Time frame: Weeks 6 and 30

Patient Global Impression

Time frame: Weeks 6 and 30

Sleep questionnaire form A

Time frame: Weeks 6 and 30

IRLSSG-RS

Time frame: Week 30

Safety evaluation including adverse events, clinically relevant changes in laboratory data, physical exam findings, and abnormalities observed in electrocardiogram

Time frame: Weeks 2, 6, and 8 during Period 1 and every 4 weeks during Period 2

Rating of severity of RLS at night (RLS-6 scale)

Time frame: Weeks 6 and 30

Rating of severity of RLS before bedtime (RLS-6 scale)

Time frame: Weeks 6 and 30

Rating of severity of RLS at day when at rest and during activities, severity of daytime sleepiness (RLS-6 scales)

Data from ClinicalTrials.gov

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Pfizer Investigational Site

Innsbruck, Austria

Pfizer Investigational Site

Vienna, Austria

Pfizer Investigational Site

Altötting, Germany

Pfizer Investigational Site

Aschaffenburg, Germany

Pfizer Investigational Site

Bad Honnef, Germany

Pfizer Investigational Site

Bad Saarow, Germany

Pfizer Investigational Site

Beckum, Germany

Pfizer Investigational Site

Berlin, Germany

Pfizer Investigational Site

Berlin, Germany

Pfizer Investigational Site

Berlin, Germany

...and 40 more locations