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

Restless Legs Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00419692
• Other study ID #: ROR106470
• Status: Completed
• Phase: Phase 1
• First received: January 5, 2007
• Last updated: October 11, 2017
• Start date: August 24, 2006
• Est. completion date: December 12, 2006

Study information

• Verified date: October 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 12, 2006
• Est. primary completion date: December 12, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Psychomotor Agitation
• Restless Legs Syndrome

Intervention

Drug:
• Ropinirole
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.

Locations

Country	Name	City	State
Germany	GSK Investigational Site	Berlin
South Africa	GSK Investigational Site	George

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Germany,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ropinirole AUC (area under the plasma concentration-time curve) over the dosing interval Ropinirole maximum plasma concentration		dosing interval
Secondary	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

External Links

•   Results for study ROR106470 can be found on the GSK Clinical Study Register.