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

Condition(s) targeted: Restless Legs Syndrome

Intervention: ropinirole controlled-release for RLS (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

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.

Official title: A 4-Week, Randomized, Double-Blind, Cohort Study to Evaluate the Safety and Tolerability of Converting From Ropinirole Immediate Release (IR) to Ropinirole Extended Release (XR) Formulation in Patients With Restless Legs Syndrome (RLS)

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: adverse events (AE) post-conversion from ropinirole IR to ropinirole controlled-release for RLS

Secondary outcome: Proportion discontinuing drug due to AEs after conversion from ropinirole IR to ropinirole controlled-release for RLS, analyses of AEs and vital signs, efficacy parameters(International RLS (IRLS) Rating Scale)

Minimum age: 18 Years. Maximum age: 79 Years. Gender(s): Both.

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.

GSK Clinical Trials Call Center, Reseda, California 91306, United States

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Starting date: November 2005
Last updated: October 26, 2006