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

NCT ID: NCT00256854

Last Updated: 2019-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-14
• Study Completion Date: 2006-09-21

Brief Summary

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.

Conditions

Restless Legs Syndrome; Restless Legs Syndrome (RLS)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT

Study Groups

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

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.

Group Type: EXPERIMENTAL

Ropinirole IR 1 mg

Intervention Type: DRUG

Ropinirole IR (SKF-101468) will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 1.0mg of active drug substance.

Ropinirole IR 1 mg Placebo

Intervention Type: DRUG

Ropinirole IR (SKF-101468) placebo will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing matching placebo tablets of 1 mg.

Ropinirole CR 2 mg

Intervention Type: DRUG

Ropinirole CR Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 2mg of the active drug substance.

Ropinirole CR 2 mg Placebo

Intervention Type: DRUG

Ropinirole CR placebo Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing matching placebo tablets of 2 mg.

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

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 Type: EXPERIMENTAL

Ropinirole IR 1 mg

Intervention Type: DRUG

Ropinirole IR (SKF-101468) will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 1.0mg of active drug substance.

Ropinirole IR 1 mg Placebo

Intervention Type: DRUG

Ropinirole IR (SKF-101468) placebo will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing matching placebo tablets of 1 mg.

Ropinirole CR 2 mg

Intervention Type: DRUG

Ropinirole CR Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 2mg of the active drug substance.

Ropinirole CR 2 mg Placebo

Intervention Type: DRUG

Ropinirole CR placebo Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing matching placebo tablets of 2 mg.

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

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 Type: EXPERIMENTAL

Ropinirole IR 2 mg

Intervention Type: DRUG

Ropinirole IR (SKF-101468) will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 2.0mg of active drug substance.

Ropinirole IR 2 mg Placebo

Intervention Type: DRUG

Ropinirole IR (SKF-101468) placebo will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing matching placebo tablets of 2 mg.

Ropinirole CR 3 mg

Intervention Type: DRUG

Ropinirole CR Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 3mg of the active drug substance.

Ropinirole CR 3 mg Placebo

Intervention Type: DRUG

Ropinirole CR placebo Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing matching placebo tablets of 3 mg.

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

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 Type: EXPERIMENTAL

Ropinirole IR 2 mg

Intervention Type: DRUG

Ropinirole IR (SKF-101468) will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 2.0mg of active drug substance.

Ropinirole IR 2 mg Placebo

Intervention Type: DRUG

Ropinirole IR (SKF-101468) placebo will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing matching placebo tablets of 2 mg.

Ropinirole CR 3 mg

Intervention Type: DRUG

Ropinirole CR Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 3mg of the active drug substance.

Ropinirole CR 3 mg Placebo

Intervention Type: DRUG

Ropinirole CR placebo Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing matching placebo tablets of 3 mg.

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

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 Type: EXPERIMENTAL

Ropinirole IR 2 mg

Intervention Type: DRUG

Ropinirole IR (SKF-101468) will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 2.0mg of active drug substance.

Ropinirole IR 2 mg Placebo

Intervention Type: DRUG

Ropinirole IR (SKF-101468) placebo will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing matching placebo tablets of 2 mg.

Ropinirole CR 3 mg

Intervention Type: DRUG

Ropinirole CR Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 3mg of the active drug substance.

Ropinirole CR 3 mg Placebo

Intervention Type: DRUG

Ropinirole CR placebo Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing matching placebo tablets of 3 mg.

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

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 Type: EXPERIMENTAL

Ropinirole IR 2 mg

Intervention Type: DRUG

Ropinirole IR (SKF-101468) will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 2.0mg of active drug substance.

Ropinirole IR 2 mg Placebo

Intervention Type: DRUG

Ropinirole IR (SKF-101468) placebo will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing matching placebo tablets of 2 mg.

Ropinirole CR 3 mg

Intervention Type: DRUG

Ropinirole CR Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 3mg of the active drug substance.

Ropinirole CR 3 mg Placebo

Intervention Type: DRUG

Ropinirole CR placebo Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing matching placebo tablets of 3 mg.

Interventions

Ropinirole IR 1 mg

Ropinirole IR (SKF-101468) will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 1.0mg of active drug substance.

Intervention Type: DRUG

Ropinirole IR 2 mg

Ropinirole IR (SKF-101468) will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 2.0mg of active drug substance.

Intervention Type: DRUG

Ropinirole IR 1 mg Placebo

Ropinirole IR (SKF-101468) placebo will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing matching placebo tablets of 1 mg.

Intervention Type: DRUG

Ropinirole IR 2 mg Placebo

Ropinirole IR (SKF-101468) placebo will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing matching placebo tablets of 2 mg.

Intervention Type: DRUG

Ropinirole CR 2 mg

Ropinirole CR Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 2mg of the active drug substance.

Intervention Type: DRUG

Ropinirole CR 3 mg

Ropinirole CR Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 3mg of the active drug substance.

Intervention Type: DRUG

Ropinirole CR 2 mg Placebo

Ropinirole CR placebo Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing matching placebo tablets of 2 mg.

Intervention Type: DRUG

Ropinirole CR 3 mg Placebo

Ropinirole CR placebo Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing matching placebo tablets of 3 mg.

Intervention Type: DRUG

Other Intervention Names

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.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Laguna Hills, California, United States

GSK Investigational Site

Oxnard, California, United States

GSK Investigational Site

Pasadena, California, United States

GSK Investigational Site

Reseda, California, United States

GSK Investigational Site

Boca Raton, Florida, United States

GSK Investigational Site

St. Petersburg, Florida, United States

GSK Investigational Site

Tampa, Florida, United States

GSK Investigational Site

Atlanta, Georgia, United States

GSK Investigational Site

Oak Brook, Illinois, United States

GSK Investigational Site

Lenexa, Kansas, United States

GSK Investigational Site

Baton Rouge, Louisiana, United States

GSK Investigational Site

Springfield, Massachusetts, United States

GSK Investigational Site

Bingham Farms, Michigan, United States

GSK Investigational Site

Las Vegas, Nevada, United States

GSK Investigational Site

Lebanon, New Hampshire, United States

GSK Investigational Site

Cherry Hill, New Jersey, United States

GSK Investigational Site

Toms River, New Jersey, United States

GSK Investigational Site

New York, New York, United States

GSK Investigational Site

Plainview, New York, United States

GSK Investigational Site

Greenville, North Carolina, United States

GSK Investigational Site

Dayton, Ohio, United States

GSK Investigational Site

Oklahoma City, Oklahoma, United States

GSK Investigational Site

Medford, Oregon, United States

GSK Investigational Site

Portland, Oregon, United States

GSK Investigational Site

Columbia, South Carolina, United States

GSK Investigational Site

Dallas, Texas, United States

GSK Investigational Site

San Antonio, Texas, United States

GSK Investigational Site

Tacoma, Washington, United States

GSK Investigational Site

Walla Walla, Washington, United States

GSK Investigational Site

Madison, Wisconsin, United States

Countries

United States

Study Documents

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

ROX104805

Identifier Type: -

Identifier Source: org_study_id