Restless Legs Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole And The Effect Of Food

This study has been completed.

First Received: January 5, 2007 Last Updated: October 15, 2008 History of Changes

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00419692

Purpose

This study in RLS patients is designed to assess the affect food has on the absorption, distribution, metabolism and excretion of ropinirole (by dosing some patients in the fasted state and other patients following a high-fat breakfast), and to assess the difference in absorption, distribution, metabolism and excretion of ropinirole if patients are given two 3mg ropinirole tablets versus one 6mg tablet.

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study
Official Title:	An Open Label, Repeat Dose, Dose Escalation Study Conducted in RLS Patients to Characterize Pharmacokinetics and Food Effect of Ropinirole Controlled Release for 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:

Ropinirole AUC (area under the plasma concentration-time curve) over the dosing interval Ropinirole maximum plasma concentration [ Time Frame: dosing interval ]

Secondary Outcome Measures:

Time to attain the maximum plasma concentration Time taken for ropinirole concentration to fall to half initial value Incidence of adverse events Vital signs, ECG and clinical laboratory data As above, but for ropinirole metabolites [ Time Frame: Time taken for ropinirole concentration to fall to half initial value ]

Enrollment:	32
Study Start Date:	August 2006

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Patients with a diagnosis of RLS
Body mass index of 18 to 32 kg/m², with a body weight of at least 50 kg
Normal blood pressure pre-study
Light smokers only (<20/day)

Exclusion criteria:

History of postural hypotension or faints
Secondary RLS
Patients who suffer from a primary sleep disorder other than RLS
Patients diagnosed with movement disorders
Patients with unstable medical conditions
Patients with personal or family history of adverse reactions or hypersensitivity to the study drug
Patients with abnormal laboratory values
Patients with hepatitis or HIV
Patients who abuse alcohol or drugs
Patients taking the following medications: dopamine agonists (including ropinirole), dopamine antagonists (e.g., metoclopramide and domperidone), levodopa/carbidopa

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00419692

Locations

Germany
GSK Investigational Site
Berlin, Germany, 14050
South Africa
GSK Investigational Site
George, South Africa, 6530

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, PhD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	ROR106470
Study First Received:	January 5, 2007
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00419692 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; South Africa: Medicines Control Council

Keywords provided by GlaxoSmithKline:

SK&F101468,
controlled release for RLS,
formulation,

pharmacokinetic,
food effect,
RLS

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