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

PHASE3CompletedINTERVENTIONAL
Enrollment

361

Participants

Timeline

Start Date

January 31, 2003

Study Completion Date

December 31, 2004

Conditions
Restless Legs Syndrome
Interventions
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

DRUG

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

Trial Locations (50)

4031

Pfizer Investigational Site, Basel

6020

Pfizer Investigational Site, Innsbruck

10969

Pfizer Investigational Site, Berlin

12163

Pfizer Investigational Site, Berlin

12687

Pfizer Investigational Site, Berlin

13053

Pfizer Investigational Site, Berlin

13507

Pfizer Investigational Site, Berlin

15526

Pfizer Investigational Site, Bad Saarow

17033

Pfizer Investigational Site, Neubrandenburg

19055

Pfizer Investigational Site, Schwerin

22359

Pfizer Investigational Site, Hamburg

25451

Pfizer Investigational Site, Quickborn

26122

Pfizer Investigational Site, Oldenburg

27568

Pfizer Investigational Site, Bremerhaven

34128

Pfizer Investigational Site, Kassel

34613

Pfizer Investigational Site, Schwalmstadt

35039

Pfizer Investigational Site, Marburg

37037

Pfizer Investigational Site, Göttingen

37075

Pfizer Investigational Site, Göttingen

40211

Pfizer Investigational Site, Düsseldorf

41179

Pfizer Investigational Site, Mönchengladbach

45891

Pfizer Investigational Site, Gelsenkirchen

49269

Pfizer Investigational Site, Beckum

53604

Pfizer Investigational Site, Bad Honnef

63739

Pfizer Investigational Site, Aschaffenburg

65191

Pfizer Investigational Site, Wiesbaden

66763

Pfizer Investigational Site, Dillingen

67655

Pfizer Investigational Site, Kaiserslautern

70176

Pfizer Investigational Site, Stuttgart

74072

Pfizer Investigational Site, Heilbronn

76137

Pfizer Investigational Site, Karlsruhe

78532

Pfizer Investigational Site, Tuttlingen

84503

Pfizer Investigational Site, Altötting

89073

Pfizer Investigational Site, Ulm

93053

Pfizer Investigational Site, Regensburg

A-1090

Pfizer Investigational Site, Vienna

Unknown

Pfizer Investigational Site, Bochum

Pfizer Investigational Site, Duisburg

Pfizer Investigational Site, Jena

Pfizer Investigational Site, Karlsruhe

Pfizer Investigational Site, Köthen

Pfizer Investigational Site, Wolfsburg

Pfizer Investigational Site, Karlstad

Pfizer Investigational Site, Bern

0755

Pfizer Investigational Site, Gera

06118

Pfizer Investigational Site, Halle

09648

Pfizer Investigational Site, Mittweida

S-413 45

Pfizer Investigational Site, Gothenburg

581 85

Pfizer Investigational Site, Linköping

CH-8091

Pfizer Investigational Site, Zurich

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY