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

Phase 1CompletedNCT00419692

GlaxoSmithKline32 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Restless Legs Syndrome

Interventions

RopiniroleDRUG

Subjects will receive ropinirole 0.5 mg for first 7 days, 1 mg from Day 8-14, 2 mg from Day 15-21, 3 mg from Day 22-28, 4 mg from Day 29-35, 5 mg from Day 36-42 and 6 mg from Day 43-51.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Ropinirole AUC (area under the plasma concentration-time curve) over the dosing interval Ropinirole maximum plasma concentration

Time frame: dosing interval

Secondary Outcomes

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

Data from ClinicalTrials.gov

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