RLS In Adults: Comparing Immediate Release Formulation With Extended Release Formulation Of Ropinirole

A 12-Week, Randomized, Double-Blind, Parallel Group, Multicentre Study to Assess the Tolerability and Clinical Benefits of Ropinirole Extended Release (XR) Tablets Compared With Ropinirole Immediate Release (IR) Tablets in Subjects With Restless Legs Syndrome (RLS)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00314860

Enrollment

568

Registered

2006-04-17

Start date

2006-02-28

Completion date

2006-12-31

Last updated

2016-10-18

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

Brief summary

Restless Legs Syndrome (RLS) study in adults comparing immediate release ropinirole with extended release ropinirole over 12 weeks

Interventions

DRUGropinirole Extended Release (XR)

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

* Diagnosis of primary RLS according to RLS Diagnostic Clinical Interview and International Restless Legs Syndrome Study Group Diagnostic Criteria. * Disturbed sleep, with both evening (between 5:00 pm and 8:00 pm) and night time (between 8:00 pm and 8:00 am) symptoms requiring treatment.

Exclusion criteria

* Signs of secondary RLS. * Primary sleep disorder or movement disorder other than RLS. * Unstable medical conditions. * Inability to tolerate dopamine agonists or dopamine antagonists. * Unwilling to discontinue any medications currently being taken to treat RLS symptoms.

Design outcomes

Primary

Measure	Time frame
To demonstrate the superior tolerability of ropinirole extended release compared to ropinirole immediate release in adult subjects with RLS requiring evening and night-time coverage of RLS symptoms	12 Weeks

Secondary

Measure	Time frame
To compare the safety profile and to evaluate the clinical benefits (as assessed by efficacy endpoints and patient-reported outcomes) of ropinirole extended release compared to ropinirole immediate release in subjects with RLS.	12 Weeks

Countries

Australia, Austria, Belgium, Denmark, France, Germany, Italy, Netherlands, Norway, Spain, Sweden, United Kingdom, United States

Outcome results

None listed

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