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

This study has been completed.

First Received on November 21, 2005. Last Updated on March 17, 2011 History of Changes

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

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: Restless Legs

Drug Information available for: Ropinirole hydrochloride Ropinirole

U.S. FDA Resources

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

Intervention Details:

Other Name: ropinirole controlled-release for RLS

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

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00256854 History of Changes
Other Study ID Numbers:	ROX104805
Study First Received:	November 21, 2005
Last Updated:	March 17, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Ropinirole
Restless Legs Syndrome
RLS

Additional relevant MeSH terms:

Restless Legs Syndrome
Psychomotor Agitation
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Parasomnias
Mental Disorders
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations

Signs and Symptoms
Ropinirole
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012