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

Completed · Phase 3 · Has a placebo group

Conditions studied: Restless Legs Syndrome, Restless Legs Syndrome (RLS)

In brief

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.

Key facts

Study ID

NCT00256854

Run by

GlaxoSmithKline

People needed

135

Starts

2005-11-14

Expected to finish

2006-09-21

Last updated by the study team

2019-03-15

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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