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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00419692

Enrollment

Registered

2007-01-09

Start date

2006-08-24

Completion date

2006-12-12

Last updated

2017-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Restless Legs Syndrome

Keywords

pharmacokinetic,, RLS, formulation,, food effect,, controlled release for RLS,, SK&F101468,

Brief 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.

Interventions

DRUGRopinirole

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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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 taken for ropinirole concentration to fall to half initial value

Countries

Germany, South Africa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026