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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Restless Legs Syndrome

Intervention: cabergoline (Drug); levodopa (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Clinical Details

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

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

Primary outcome:

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

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 outcome:

RLS quality-of-life questionnaire

Clinical Global Impression

Patient Global Impression

Sleep questionnaire form A

IRLSSG-RS

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

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

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

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

Global rating of quality of sleep (RLS-6 scale)

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

Locations and Contacts

Pfizer Investigational Site, Innsbruck 6020, Austria

Pfizer Investigational Site, Wien A-1090, Austria

Pfizer Investigational Site, Altoetting 84503, Germany

Pfizer Investigational Site, Aschaffenburg 63739, Germany

Pfizer Investigational Site, Bad Honnef 53604, Germany

Pfizer Investigational Site, Bad Saarow 15526, Germany

Pfizer Investigational Site, Beckum 49269, Germany

Pfizer Investigational Site, Berlin 10969, Germany

Pfizer Investigational Site, Berlin 12163, Germany

Pfizer Investigational Site, Berlin 12687, Germany

Pfizer Investigational Site, Berlin 13053, Germany

Pfizer Investigational Site, Berlin 13507, Germany

Pfizer Investigational Site, Bochum, Germany

Pfizer Investigational Site, Bremerhaven 27568, Germany

Pfizer Investigational Site, Dillingen 66763, Germany

Pfizer Investigational Site, Duesseldorf 40211, Germany

Pfizer Investigational Site, Duisburg, Germany

Pfizer Investigational Site, Gelsenkirchen 45891, Germany

Pfizer Investigational Site, Gera 0755, Germany

Pfizer Investigational Site, Goettingen 37037, Germany

Pfizer Investigational Site, Goettingen 37075, Germany

Pfizer Investigational Site, Halle 06118, Germany

Pfizer Investigational Site, Hamburg 22359, Germany

Pfizer Investigational Site, Heilbronn 74072, Germany

Pfizer Investigational Site, Jena, Germany

Pfizer Investigational Site, Kaiserslautern 67655, Germany

Pfizer Investigational Site, Karlsruhe 76137, Germany

Pfizer Investigational Site, Karlsruhe, Germany

Pfizer Investigational Site, Kassel 34128, Germany

Pfizer Investigational Site, Köthen, Germany

Pfizer Investigational Site, Marburg 35039, Germany

Pfizer Investigational Site, Mittweida 09648, Germany

Pfizer Investigational Site, Moenchengladbach 41179, Germany

Pfizer Investigational Site, Neubrandenburg 17033, Germany

Pfizer Investigational Site, Oldenburg 26122, Germany

Pfizer Investigational Site, Quickborn 25451, Germany

Pfizer Investigational Site, Regensburg 93053, Germany

Pfizer Investigational Site, Schwalmstadt 34613, Germany

Pfizer Investigational Site, Schwerin 19055, Germany

Pfizer Investigational Site, Stuttgart 70176, Germany

Pfizer Investigational Site, Tuttlingen 78532, Germany

Pfizer Investigational Site, Ulm 89073, Germany

Pfizer Investigational Site, Wiesbaden 65191, Germany

Pfizer Investigational Site, Wolfsburg, Germany

Pfizer Investigational Site, Goteborg S-413 45, Sweden

Pfizer Investigational Site, Karlstad, Sweden

Pfizer Investigational Site, Linköping 581 85, Sweden

Pfizer Investigational Site, Basel 4031, Switzerland

Pfizer Investigational Site, Bern, Switzerland

Pfizer Investigational Site, Zürich CH-8091, Switzerland

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: January 2003
Last updated: October 28, 2008

Page last updated: August 23, 2015

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