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

Purpose

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.

Condition	Intervention	Phase
Restless Legs Syndrome	Drug: ropinirole controlled-release for RLS	Phase III

MedlinePlus related topics:

Restless Legs

ChemIDplus related topics:

Ropinirole Ropinirole hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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)

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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)

Estimated Enrollment:	150
Study Start Date:	November 2005

Eligibility

Ages Eligible for Study:	18 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00256854

Show 29 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials, MD	GlaxoSmithKline

More Information

Study ID Numbers:	ROX104805
First Received:	November 21, 2005
Last Updated:	October 26, 2006
ClinicalTrials.gov Identifier:	NCT00256854
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Ropinirole

Restless Legs Syndrome

RLS

Study placed in the following topic categories:

Ropinirole

Ekbom syndrome

Sleep Disorders

Dyssomnias

Psychomotor Agitation

Dyskinesias

Sleep Disorders, Intrinsic

Signs and Symptoms

Dopamine

Mental Disorders

Restless Legs Syndrome

Neurologic Manifestations

Neurobehavioral Manifestations

Additional relevant MeSH terms:

Neurotransmitter Agents

Disease

Molecular Mechanisms of Pharmacological Action

Anti-Dyskinesia Agents

Physiological Effects of Drugs

Nervous System Diseases

Parasomnias

Antiparkinson Agents

Dopamine Agonists

Pharmacologic Actions

Pathologic Processes

Syndrome

Therapeutic Uses

Psychomotor Disorders

Dopamine Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on September 19, 2008

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00256854