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

Pfizer

Status and phase: Completed; Phase 3

Conditions: Restless Legs Syndrome

Treatments: Drug: levodopa; Drug: cabergoline

Study type: Interventional

Funder types: Industry

Identifiers

NCT00625547

CABAS-0067-031

Details and patient eligibility

About

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

Enrollment: 361 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

361 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: cabergoline

2

Experimental group

Treatment:

Drug: levodopa