Ropinirole Tablets In Young Patients With Restless Legs Syndrome - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00140712

Purpose

This is a two-period dose rising study of Ropinirole Immediate Release in adolescent patients with restless legs syndrome (RLS) in order to determine the starting dose for the ropinirole titration regimen for this age group. Patients will receive two single doses unless poor tolerability is observed following the first dose.

Condition	Intervention	Phase
Restless Legs Syndrome (RLS)	Drug: Ropinirole Immediate Release	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study
Official Title:	An Open Label, Single Dose, Dose Rising, Multi-Centre Study to Assess the Tolerability and Pharmacokinetics of Ropinirole Immediate Release in Adolescent Patients With 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:

AUC(0-8), Cmax. Safety (adverse events, vital signs, ECG, laboratory parameters), Change in BP, Incidence of adverse events. Number of periodic limb movements and Number of periodic limb movements per hour (as measured by actigraphy).

Secondary Outcome Measures:

PK - tmax, t1/2, For SKF-89124 and SKF-104557 - ratio of metabolite AUC:ropinirole AUC. PD - Leg movement as measured by actigraphy.

Estimated Enrollment:	20
Study Start Date:	June 2005

Eligibility

Ages Eligible for Study:	12 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adolescent subjects diagnosed with probable or definite Restless Leg Syndrome (RLS).

Exclusion Criteria:

Subjects who require RLS treatment during the daytime, suffer from other primary sleep disorders or are taking medication known to induce drowsiness, affect RLS or sleep, or to induce or treat alertness, including methylphenidate.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00140712

Locations

United States, District of Columbia
GSK Investigational Site
Washington, District of Columbia, United States, 20010
United States, Georgia
GSK Investigational Site
Macon, Georgia, United States, 31201
United States, Illinois
GSK Investigational Site
Chicago, Illinois, United States, 60611
United States, Kentucky
GSK Investigational Site
Louisville, Kentucky, United States, 40202
United States, Missouri
GSK Investigational Site
Kansas City, Missouri, United States, 64108
United States, New Jersey
GSK Investigational Site
Edison, New Jersey, United States, 08818
United States, North Carolina
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27599
Belgium
GSK Investigational Site
Brussels, Belgium, 1020
France
GSK Investigational Site
Paris, France, 75019

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:	101468/253, SK&F101468/253
Study First Received:	August 31, 2005
Last Updated:	June 4, 2009
ClinicalTrials.gov Identifier:	NCT00140712 History of Changes
Health Authority:	United States: Food and Drug Administration; Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment; France: Afssaps - French Health Products Safety Agency; United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Adolescent
Periodic Limb Movements of Sleep
PLMS
RLS
Ropinirole

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 November 27, 2009