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 Restless Legs Syndrome (RLS)	Drug: ropinirole controlled-release for RLS	Phase 3

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

Hide Study Locations

Locations

United States, California
GSK Investigational Site
Oxnard, California, United States, 93030
GSK Investigational Site
Pasadena, California, United States, 91106
GSK Investigational Site
Reseda, California, United States, 91355
United States, Florida
GSK Investigational Site
Boca Raton, Florida, United States, 33486
GSK Investigational Site
St. Petersburg, Florida, United States, 33701
GSK Investigational Site
Tampa, Florida, United States, 33609
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30342
United States, Illinois
GSK Investigational Site
Oak Brook, Illinois, United States, 60523
United States, Kansas
GSK Investigational Site
Lenexa, Kansas, United States, 66214
United States, Louisiana
GSK Investigational Site
Baton Rouge, Louisiana, United States, 70808
United States, Massachusetts
GSK Investigational Site
Springfield, Massachusetts, United States, 01104
United States, Michigan
GSK Investigational Site
Bingham Farms, Michigan, United States, 48025
United States, Nevada
GSK Investigational Site
Las Vegas, Nevada, United States, 89119
United States, New Hampshire
GSK Investigational Site
Lebanon, New Hampshire, United States, 03766
United States, New Jersey
GSK Investigational Site
Cherry Hill, New Jersey, United States, 08003
GSK Investigational Site
Toms River, New Jersey, United States, 08755
United States, New York
GSK Investigational Site
New York, New York, United States, 10021
GSK Investigational Site
Plainview, New York, United States, 11803
United States, North Carolina
GSK Investigational Site
Greenville, North Carolina, United States, 27834
United States, Ohio
GSK Investigational Site
Dayton, Ohio, United States, 46432
United States, Oklahoma
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73112
United States, Oregon
GSK Investigational Site
Medford, Oregon, United States, 97504-8456
GSK Investigational Site
Portland, Oregon, United States, 97210
United States, South Carolina
GSK Investigational Site
Columbia, South Carolina, United States, 29201
United States, Texas
GSK Investigational Site
Dallas, Texas, United States, 75213
GSK Investigational Site
San Antonio, Texas, United States, 78229
United States, Washington
GSK Investigational Site
Tacoma, Washington, United States, 98405
GSK Investigational Site
Walla Walla, Washington, United States, 99362
United States, Wisconsin
GSK Investigational Site
Madison, Wisconsin, United States, 53715

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00256854 History of Changes
Other Study ID Numbers:	ROX104805
Study First Received:	November 21, 2005
Last Updated:	May 31, 2012
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 June 18, 2013