Loading clinical trials...

Restless Legs Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole And The Effect Of Food | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

An Open Label, Repeat Dose, Dose Escalation Study Conducted in RLS Patients to Characterize Pharmacokinetics and Food Effect of Ropinirole Controlled Release for RLS

NCT00419692•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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

Locations (2)

GSK Investigational Site

Berlin, Germany

GSK Investigational Site

George, South Africa

Key Dates

Start Date

August 24, 2006

Primary Completion Date

December 12, 2006

Completion Date

December 12, 2006

Last Updated

October 13, 2017

Enrollment

ACTUAL participants

Conditions

Restless Legs Syndrome

Interventions

Ropinirole

DRUG

Functional Connectivity of the Interoceptive Network in RLS

NCT07001891

Restless Legs Syndrome

View study

RECRUITINGNA

The Application of Wide Pulse High Frequency Neuromuscular Electrical Stimulation in Disorders Associated With Motoneuron Hyperexcitability

NCT05908214

StrokeCramp+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 13, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Functional Connectivity of the Interoceptive Network in RLS

The Application of Wide Pulse High Frequency Neuromuscular Electrical Stimulation in Disorders Associated With Motoneuron Hyperexcitability

Quality Improvement and Practice Based Research in Neurology Using the EMR

A Post-Market Study for Long-Term Effectiveness and Safety of the NTX100 for RLS

Adverse Long-term Consequences of Sleep Disordered Breathing: The Ottawa Hospital (TOH) Sleep Database

Impact of Iron Supplementation Treatment on Brain Iron Concentrations