RLS In Adults: Comparing Immediate Release Formulation With Extended Release Formulation Of Ropinirole

Completed · Phase 3

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

In brief

Restless Legs Syndrome (RLS) study in adults comparing immediate release ropinirole with extended release ropinirole over 12 weeks

Key facts

Study ID

NCT00314860

Run by

GlaxoSmithKline

People needed

568

Starts

2006-02-01

Expected to finish

2006-12-01

Last updated by the study team

2016-10-18

Who can join

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

You may qualify if…

• Diagnosis of primary RLS according to RLS Diagnostic Clinical Interview and International Restless Legs Syndrome Study Group Diagnostic Criteria.
• Disturbed sleep, with both evening (between 5:00 pm and 8:00 pm) and night time (between 8:00 pm and 8:00 am) symptoms requiring treatment.

You may not qualify if…

• Signs of secondary RLS.
• Primary sleep disorder or movement disorder other than RLS.
• Unstable medical conditions.
• Inability to tolerate dopamine agonists or dopamine antagonists.
• Unwilling to discontinue any medications currently being taken to treat RLS symptoms.

Where it is running

• GSK Investigational Site — Mesa, Arizona, United States
• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Sun City, Arizona, United States
• GSK Investigational Site — Anaheim, California, United States
• GSK Investigational Site — Burlingame, California, United States
• GSK Investigational Site — Long Beach, California, United States
• GSK Investigational Site — Newport Beach, California, United States
• GSK Investigational Site — Pasadena, California, United States
• GSK Investigational Site — Redondo Beach, California, United States
• GSK Investigational Site — Santa Monica, California, United States
• GSK Investigational Site — Stanford, California, United States
• GSK Investigational Site — Winnetka, California, United States
• GSK Investigational Site — Boca Raton, Florida, United States
• GSK Investigational Site — Coeur d'Alene, Idaho, United States
• GSK Investigational Site — Springfield, Massachusetts, United States
• GSK Investigational Site — West Yarmouth, Massachusetts, United States
• GSK Investigational Site — Worcester, Massachusetts, United States
• GSK Investigational Site — Kalamazoo, Michigan, United States
• GSK Investigational Site — Saint Paul, Minnesota, United States
• GSK Investigational Site — St Louis, Missouri, United States
• GSK Investigational Site — Las Vegas, Nevada, United States
• GSK Investigational Site — Albany, New York, United States
• GSK Investigational Site — Tabor City, North Carolina, United States
• GSK Investigational Site — Fargo, North Dakota, United States
• GSK Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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