12-week Polysomnography Study of Ropinirole Controlled Release for Restless Legs Syndrome

A 12-Week, Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group, Flexible Dose Polysomnography Study of Ropinirole Controlled Release for Restless Legs Syndrome (RLS) in RLS Patients With Sleep Disturbance and Periodic Limb Movements (PLM) During Sleep

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00373542

Acronym

(CR-RLS)

Enrollment

Registered

2006-09-08

Start date

2006-10-31

Completion date

2007-06-30

Last updated

2016-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Restless Legs Syndrome, Restless Legs Syndrome (RLS)

Keywords

Restless Legs Syndrome, ropinirole, polysomnography, RLS, PSG

Brief summary

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.

Interventions

DRUGropinirole CR-RLS

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 79 Years

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.

Design outcomes

Primary

Measure	Time frame
Change from baseline in the Periodic Limb Movements in Sleep associated with Arousal/hour of sleep (PLMAI) at Week 12 Change from baseline in sleep Latency at Week 12.	12 Weeks

Secondary

Measure	Time frame
Assess safety, tolerability, polysomnography efficacy measures, and patient reported outcomes.	12 Weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026