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

This study has been completed.

First Received: April 13, 2006 Last Updated: May 21, 2009 History of Changes

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00314860

Purpose

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

Condition	Intervention	Phase
Restless Legs Syndrome (RLS)	Drug: ropinirole Extended Release (XR)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	A 12-Week, Randomized, Double-Blind, Parallel Group, Multicentre Study to Assess the Tolerability and Clinical Benefits of Ropinirole Extended Release (XR) Tablets Compared With Ropinirole Immediate Release (IR) Tablets in Subjects 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:

To demonstrate the superior tolerability of ropinirole extended release compared to ropinirole immediate release in adult subjects with RLS requiring evening and night-time coverage of RLS symptoms [ Time Frame: 12 Weeks ]

Secondary Outcome Measures:

To compare the safety profile and to evaluate the clinical benefits (as assessed by efficacy endpoints and patient-reported outcomes) of ropinirole extended release compared to ropinirole immediate release in subjects with RLS. [ Time Frame: 12 Weeks ]

Enrollment:	480
Study Start Date:	February 2006

Eligibility

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

Criteria

Inclusion Criteria:

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.

Exclusion criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00314860

Show 85 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	101468/204
Study First Received:	April 13, 2006
Last Updated:	May 21, 2009
ClinicalTrials.gov Identifier:	NCT00314860 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Restless Legs Syndrome

Additional relevant MeSH terms:

Ropinirole
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Sleep Disorders
Antiparkinson Agents
Psychomotor Agitation
Dopamine Agonists
Sleep Disorders, Intrinsic
Signs and Symptoms
Pathologic Processes
Mental Disorders
Syndrome

Therapeutic Uses
Restless Legs Syndrome
Psychomotor Disorders
Neurobehavioral Manifestations
Disease
Parasomnias
Nervous System Diseases
Dyssomnias
Dyskinesias
Pharmacologic Actions
Neurologic Manifestations
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010