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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Restless Legs Syndrome; Restless Legs Syndrome (RLS)

Treatments: Drug: Ropinirole IR 1 mg; Drug: Ropinirole IR 2 mg; Drug: Ropinirole CR 2 mg Placebo; Drug: Ropinirole CR 2 mg; Drug: Ropinirole CR 3 mg Placebo; Drug: Ropinirole CR 3 mg; Drug: Ropinirole IR 2 mg Placebo; Drug: Ropinirole IR 1 mg Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00256854

ROX104805

Details and patient eligibility

About

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.

Enrollment: 135 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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.
• Subjects who have given written informed consent to participate.

Exclusion criteria

• Subjects who require treatment of daytime RLS symptoms.
• Signs of secondary RLS, serum ferritin level less than 10 mcg/L.
• Movement Disorders, Clinically significant or unstable medical conditions.
• Abnormal labs, electrocardiogram (ECG) or physical findings.
• Receiving prohibited medications.
• Sleeping habits incompatible with study design.
• Intolerance to ropinirole or other dopamine agonist.
• Pregnant or lactating.
• Women of child-bearing potential who are not practicing an acceptable method of birth control.

Trial design

135 participants in 6 patient groups

Ropinirole cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR

Experimental group

Description:

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.

Treatment:

Drug: Ropinirole CR 2 mg Placebo

Drug: Ropinirole CR 2 mg

Drug: Ropinirole IR 1 mg Placebo

Drug: Ropinirole IR 1 mg

Ropinirole cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS

Experimental group

Description:

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.

Treatment:

Drug: Ropinirole CR 2 mg Placebo

Drug: Ropinirole CR 2 mg

Drug: Ropinirole IR 1 mg Placebo

Drug: Ropinirole IR 1 mg

Ropinirole cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR

Experimental group

Description:

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.

Treatment:

Drug: Ropinirole IR 2 mg Placebo

Drug: Ropinirole CR 3 mg Placebo

Drug: Ropinirole CR 3 mg

Drug: Ropinirole IR 2 mg

Ropinirole cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS

Experimental group

Description:

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.

Treatment:

Drug: Ropinirole IR 2 mg Placebo

Drug: Ropinirole CR 3 mg Placebo

Drug: Ropinirole CR 3 mg

Drug: Ropinirole IR 2 mg

Ropinirole cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR

Experimental group

Description:

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.

Treatment:

Drug: Ropinirole IR 2 mg Placebo

Drug: Ropinirole CR 3 mg Placebo

Drug: Ropinirole CR 3 mg

Drug: Ropinirole IR 2 mg

Ropinirole cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS

Experimental group

Description:

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.

Treatment:

Drug: Ropinirole IR 2 mg Placebo

Drug: Ropinirole CR 3 mg Placebo

Drug: Ropinirole CR 3 mg

Drug: Ropinirole IR 2 mg