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

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	Drug: Ropinirole Immediate Release	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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:

Genetics Home Reference related topics: restless legs syndrome

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). [ Designated as safety issue: Yes ]

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. [ Designated as safety issue: No ]


Enrollment:	20
Study Start Date:	June 2005
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Ropinirole single dose .25mg of IR formulation, .05mg of RLS controlled release	Drug: Ropinirole Immediate Release

Eligibility


Ages Eligible for Study:	12 Years to 17 Years (Child)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Bruxelles, Belgium, 1020
France
GSK Investigational Site
Paris, France, 75019

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information


Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00140712 History of Changes
Other Study ID Numbers:	101468/253
Study First Received:	August 31, 2005
Last Updated:	September 24, 2015
Health Authority:	United States: Food and Drug Administration France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

Keywords provided by GlaxoSmithKline:


Adolescent RLS Periodic Limb Movements of Sleep PLMS Ropinirole

Additional relevant MeSH terms:


Syndrome Psychomotor Agitation Restless Legs Syndrome Disease Pathologic Processes Dyskinesias Neurologic Manifestations Nervous System Diseases Psychomotor Disorders Neurobehavioral Manifestations Signs and Symptoms Sleep Disorders, Intrinsic	Dyssomnias Sleep Wake Disorders Parasomnias Mental Disorders Ropinirole Antiparkinson Agents Anti-Dyskinesia Agents Dopamine Agonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 23, 2016