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

NCT00256854 | Completed Phase 3 Results

• 1 other identifier: ROX104805
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 30

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)

Keywords

RLS; Ropinirole; Restless Legs Syndrome

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events (AEs) Post-conversion From Ropinirole IR to Ropinirole CR Over Period

  AE is an unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain time period after the study has ended. This change may or may not be caused by the intervention being studied. In each of the 6 cohorts, there were 2 conversions, one of which was IR to CR-RLS and the other one IR to IR. Two populations were defined: the first conversion population and the second conversion population. The first conversion population consisted of all participants receiving at least one dose of randomized drug during the pre-conversion 1 period and during the post-conversion 1 period. The second conversion population consisted of all participants receiving at least one dose of randomized drug during the pre-conversion 2 period and during the post-conversion 2 period.

  Up to 5 weeks

Secondary Outcomes (8)

• Number of Participants Discontinuing the Drug Due to AEs Post Conversion From Ropinirole IR to Ropinirole CR-RLS

  Up to 5 weeks

• Number of Participants With SAEs and Severity of AEs

  Up to 5 weeks

• Number of Participants With Positive Scores (Improved) on Clinical Global Impression Improvement Scale (CGI-I) Pre-conversion and One Week Post-conversion

  Up to 4 weeks

• Change From Pre-conversion in International RLS (IRLS) Rating Scale Total Score to One Week Post-conversion

  Up to 5 weeks

• Number of Participants With pre-and One Week Post-conversion Values of Vital Signs of Potential Clinical Concern (PCC)

  Up to 5 weeks

Study Arms (6)

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

EXPERIMENTAL

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.

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

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

EXPERIMENTAL

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.

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

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

EXPERIMENTAL

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.

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

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

EXPERIMENTAL

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.

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

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

EXPERIMENTAL

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.

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

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

EXPERIMENTAL

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.

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

Interventions

Ropinirole IR 1 mg 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.

Also known as: ropinirole controlled-release for RLS

Ropinirole cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR; Ropinirole cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS

Ropinirole IR 2 mg 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 cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR; Ropinirole cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS; Ropinirole cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR; Ropinirole cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS

Ropinirole IR 1 mg Placebo 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 cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR; Ropinirole cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS

Ropinirole IR 2 mg Placebo 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 cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR; Ropinirole cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS; Ropinirole cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR; Ropinirole cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS

Ropinirole CR 2 mg 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 cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR; Ropinirole cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS

Ropinirole CR 3 mg 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 cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR; Ropinirole cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS; Ropinirole cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR; Ropinirole cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS

Ropinirole CR 2 mg Placebo 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 A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR; Ropinirole cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS

Ropinirole CR 3 mg Placebo 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 B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR; Ropinirole cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS; Ropinirole cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR; Ropinirole cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (30)

GSK Investigational Site

Laguna Hills, California, 82653, United States

Location

GSK Investigational Site

Oxnard, California, 93030, United States

Location

GSK Investigational Site

Pasadena, California, 91106, United States

Location

GSK Investigational Site

Reseda, California, 91355, United States

Location

GSK Investigational Site

Boca Raton, Florida, 33486, United States

Location

GSK Investigational Site

St. Petersburg, Florida, 33701, United States

Location

GSK Investigational Site

Tampa, Florida, 33609, United States

Location

GSK Investigational Site

Atlanta, Georgia, 30342, United States

Location

GSK Investigational Site

Oak Brook, Illinois, 60523, United States

Location

GSK Investigational Site

Lenexa, Kansas, 66214, United States

Location

GSK Investigational Site

Baton Rouge, Louisiana, 70808, United States

Location

GSK Investigational Site

Springfield, Massachusetts, 01104, United States

Location

GSK Investigational Site

Bingham Farms, Michigan, 48025, United States

Location

GSK Investigational Site

Las Vegas, Nevada, 89119, United States

Location

GSK Investigational Site

Lebanon, New Hampshire, 03766, United States

Location

GSK Investigational Site

Cherry Hill, New Jersey, 08003, United States

Location

GSK Investigational Site

Toms River, New Jersey, 08755, United States

Location

GSK Investigational Site

New York, New York, 10021, United States

Location

GSK Investigational Site

Plainview, New York, 11803, United States

Location

GSK Investigational Site

Greenville, North Carolina, 27834, United States

Location

GSK Investigational Site

Dayton, Ohio, 46432, United States

Location

GSK Investigational Site

Oklahoma City, Oklahoma, 73112, United States

Location

GSK Investigational Site

Medford, Oregon, 97504-8456, United States

Location

GSK Investigational Site

Portland, Oregon, 97210, United States

Location

GSK Investigational Site

Columbia, South Carolina, 29201, United States

Location

GSK Investigational Site

Dallas, Texas, 75213, United States

Location

GSK Investigational Site

San Antonio, Texas, 78229, United States

Location

GSK Investigational Site

Tacoma, Washington, 98405, United States

Location

GSK Investigational Site

Walla Walla, Washington, 99362, United States

Location

GSK Investigational Site

Madison, Wisconsin, 53715, United States

Location

Related Links

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

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

ropinirole

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2005
• First Posted: November 22, 2005
• Study Start: November 14, 2005
• Primary Completion: September 21, 2006
• Study Completion: September 21, 2006
• Last Updated: March 15, 2019
• Results First Posted: March 15, 2019

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will share

Locations

US (30)