12-week Polysomnography Study of Ropinirole Controlled Release for Restless Legs Syndrome ((CR-RLS))

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 4

Conditions

Restless Legs Syndrome

Restless Legs Syndrome (RLS)

Treatments

Drug: ropinirole CR-RLS

Study type

Interventional

Funder types

Industry

Identifiers

NCT00373542

RRL103660

Details and patient eligibility

About

The purpose of this study is to assess the efficacy and safety of ropinirole CR-RLS in the treatment of patients with Restless Legs Syndrome and associated sleep disturbance and period limb movements during sleep.

Enrollment

39 patients

Sex

All

Ages

18 to 79 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

provided written informed consent.
Diagnosed with primary RLS using the International RLS Study Group Diagnostic Criteria with a total score of 20 or greater on the International RLS (IRLS) Rating Scale and significant sleep disturbance indicated on Item 4 of the IRLS rating scale.
Have evening and nighttime symptoms of RLS, significant sleep impairment due to RLS symptoms, and symptoms requiring treatment prior to bedtime, but no earlier than 5:00PM.
Sleep efficiency <85% OR Latency to persistent sleep >20 minutes.

Exclusion criteria

Secondary RLS
Primary sleep disorder
Have any medical conditions that may impact efficacy assessments or that may present a safety concern.
Pregnant or lactating or women of child-bearing potential who are not practicing an acceptable method of birth control.
Use of any prohibited medication.