Clinical Trials Logo
  1. Home
  2. Restless Legs Syndrome
  3. NCT00625547
  4. Details
NCT00625547 Clinical Trial

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

Restless Legs Syndrome Clinical Trial

Official title:
A Double-Blind, Randomized, Active-Controlled Multicenter Efficacy Trial for the Treatment of Patients With Restless Legs Syndrome (RLS)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00625547
Other study ID # CABAS-0067-031
Secondary ID
Status Completed
Phase Phase 3
First received February 19, 2008
Last updated October 28, 2008
Start date January 2003
Est. completion date December 2004

Study information
Verified date October 2008
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 361
Est. completion date December 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• cabergoline
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
• levodopa
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

Locations
Country Name City State
Austria Pfizer Investigational Site Innsbruck
Austria Pfizer Investigational Site Wien
Germany Pfizer Investigational Site Altoetting
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 Pfizer Investigational Site Berlin
Germany Pfizer Investigational Site Berlin
Germany Pfizer Investigational Site Bochum
Germany Pfizer Investigational Site Bremerhaven
Germany Pfizer Investigational Site Dillingen
Germany Pfizer Investigational Site Duesseldorf
Germany Pfizer Investigational Site Duisburg
Germany Pfizer Investigational Site Gelsenkirchen
Germany Pfizer Investigational Site Gera
Germany Pfizer Investigational Site Goettingen
Germany Pfizer Investigational Site Goettingen
Germany Pfizer Investigational Site Halle
Germany Pfizer Investigational Site Hamburg
Germany Pfizer Investigational Site Heilbronn
Germany Pfizer Investigational Site Jena
Germany Pfizer Investigational Site Kaiserslautern
Germany Pfizer Investigational Site Karlsruhe
Germany Pfizer Investigational Site Karlsruhe
Germany Pfizer Investigational Site Kassel
Germany Pfizer Investigational Site Köthen
Germany Pfizer Investigational Site Marburg
Germany Pfizer Investigational Site Mittweida
Germany Pfizer Investigational Site Moenchengladbach
Germany Pfizer Investigational Site Neubrandenburg
Germany Pfizer Investigational Site Oldenburg
Germany Pfizer Investigational Site Quickborn
Germany Pfizer Investigational Site Regensburg
Germany Pfizer Investigational Site Schwalmstadt
Germany Pfizer Investigational Site Schwerin
Germany Pfizer Investigational Site Stuttgart
Germany Pfizer Investigational Site Tuttlingen
Germany Pfizer Investigational Site Ulm
Germany Pfizer Investigational Site Wiesbaden
Germany Pfizer Investigational Site Wolfsburg
Sweden Pfizer Investigational Site Goteborg
Sweden Pfizer Investigational Site Karlstad
Sweden Pfizer Investigational Site Linköping
Switzerland Pfizer Investigational Site Basel
Switzerland Pfizer Investigational Site Bern
Switzerland Pfizer Investigational Site Zürich

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

Austria,  Germany,  Sweden,  Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in the total score of the International RLS Study Group Rating Scale (IRLSSG-RS) Week 6 No
Primary 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) No
Secondary RLS quality-of-life questionnaire Weeks 6 and 30 No
Secondary Clinical Global Impression Weeks 6 and 30 No
Secondary Patient Global Impression Weeks 6 and 30 No
Secondary Sleep questionnaire form A Weeks 6 and 30 No
Secondary IRLSSG-RS Week 30 No
Secondary Safety evaluation including adverse events, clinically relevant changes in laboratory data, physical exam findings, and abnormalities observed in electrocardiogram Weeks 2, 6, and 8 during Period 1 and every 4 weeks during Period 2 No
Secondary Rating of severity of RLS at night (RLS-6 scale) Weeks 6 and 30 No
Secondary Rating of severity of RLS before bedtime (RLS-6 scale) Weeks 6 and 30 No
Secondary Rating of severity of RLS at day when at rest and during activities, severity of daytime sleepiness (RLS-6 scales) Weeks 6 and 30 No
Secondary Global rating of quality of sleep (RLS-6 scale) Weeks 6 and 30 No
See also
  Status Clinical Trial Phase
Recruiting NCT04786314 - The Effect of Hot and Cold Water Application on Pregnant Women With Restless Leg Syndrome N/A
Completed NCT01455012 - Effects of Neupro on Cardiovascular Observations in Patients With Restless Legs Syndrome Phase 4
Terminated NCT01192503 - Safety and Efficacy of Rasagiline in Restless Legs Syndrome Phase 2/Phase 3
Completed NCT00530530 - ASP8825 - Study in Patients With Restless Legs Syndrome Phase 2
Completed NCT00721279 - Sifrol (Pramipexole) Onset of Action and Impact: a 12-weeks Observational Study in Patients With Primary Restless Legs Syndrome N/A
Completed NCT00375284 - A 6 Week Trial to Study the Efficacy and Safety of a Starting Dose 0.25 mg Pramipexole (Mirapex) in Patients With RLS Phase 4
Completed NCT00942253 - Exercise Training in Dialysis Patients With Restless Legs Syndrome (RLS) Phase 2
Completed NCT00479531 - Sequential Compression Devices for Treatment of Restless Legs Syndrome Phase 3
Recruiting NCT05581576 - Pitolisant in Refractory Restless Legs Syndrome Phase 4
Active, not recruiting NCT03218969 - Treatment of Restless Leg Syndrome (RLS) Augmentation With Ecopipam, a D1 Specific Antagonist Phase 1/Phase 2
Recruiting NCT04144790 - Impact of Iron Supplementation Treatment on Brain Iron Concentrations
Completed NCT05787080 - Massage, Oxidative and Antioxidant Enzymes in Hemodialysis Patients With Restless Legs Syndrome(RLS) N/A
Not yet recruiting NCT05529095 - Sublingual Apomorphine in Refractory Restless Legs Syndrome Phase 4
Recruiting NCT05044520 - Clinical Features Associated With Restless Legs Syndrome.
Withdrawn NCT03849001 - Impact of Acute Leg Cycling at Various Intensities on RLS Severity in Persons With MS N/A
Completed NCT03076541 - Cardiovascular Variability, Heart Rate Response, and Electromyogram Power Associated With Periodic Leg Movements. N/A
Recruiting NCT04145674 - A Proof of Concept, Phase 2, Double-blind, Randomized Trial With d-Methadone Product Versus Placebo Phase 2
Completed NCT02532608 - Infra-slow Oscillations During Sleep N/A
Completed NCT01528462 - Sleep Disorders Managed and Assessed Rapidly in Transient Ischemic Attack (TIA) and In Early Stroke
Completed NCT00748098 - Polysomnography Study of GSK1838262 Extended Release Tablets Versus Placebo in RLS and Associated Sleep Disturbance Phase 3

External Links