Converting From Ropinirole Immediate Release (IR) To Ropinirole Controlled-Release for RLS (Restless Legs Syndrome)

Recruiting in Palo Alto (17 mi)

+29 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: GlaxoSmithKline

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This is a multi-center, Phase III study to evaluate the safety and tolerability of proposed dose conversion recommendations for RLS subjects converting from ropinirole immediate release to ropinirole controlled-release for RLS.

Eligibility Criteria

Inclusion Criteria

Diagnosis of RLS using IRLS Study Group (IRLSSG) diagnostic criteria.

Subjects currently being treated for RLS with a stable dose (for at least 2 weeks) of ropinirole IR given once daily.

Subjects with RLS symptoms during both the evening and night or night time only.

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Treatment Details

Interventions

Ropinirole CR (Dopamine Agonist)
Ropinirole IR (Dopamine Agonist)

Participant Groups

6Treatment groups

Experimental Treatment

Group I: Ropinirole cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLSExperimental Treatment4 Interventions

Participants received Placebo in the evening and Ropinirole 4 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 6 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.

Group II: Ropinirole cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IRExperimental Treatment4 Interventions

Participants received Placebo in the evening and Ropinirole 4 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 6 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 4 mg IR at bedtime and continued to receive the same till the end of Week 4.

Group III: Ropinirole cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLSExperimental Treatment4 Interventions

Participants received Placebo in the evening and Ropinirole 2 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 3 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.

Group IV: Ropinirole cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IRExperimental Treatment4 Interventions

Participants received Placebo in the evening and Ropinirole 2 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 3 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 2 mg IR at bedtime and continued to receive the same till the end of Week 4.

Group V: Ropinirole cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLSExperimental Treatment4 Interventions

Participants received Placebo in the evening and Ropinirole 1 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 2 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.

Group VI: Ropinirole cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IRExperimental Treatment4 Interventions

Participants received Placebo in the evening and Ropinirole 1 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 2 mg controlled release for Restless Legs Syndrome (CR-RLS) in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 1 mg IR at bedtime and continued to receive the same till the end of Week 4.