MedTrace Logo

Clinical Evaluation of Ropinirole PR/XR Tablets in Monotherapy for Parkinson's Disease (PD)

NCT00434304 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2018-09-27

Study results available
· View outcomes & findings →

Summary

This study was designed to evaluate the pharmacokinetic profile, safety and efficacy in Parkinson's Disease patients.

Conditions

  • Parkinson Disease

Interventions

DRUG

Ropinirole prolonged release/extended release(PR/XR)

Subjects will take the investigational drug once daily at the same time each day, it is recommended that this is in the morning for optimal benefit. Investigational drug is taken for 52 weeks, starting on the next day of the Week 0 visit. One tablet of ropinirole PR/XR 2 mg tablets will be orally dosed as the initial dose. The dose will be titrated weekly by 2 mg/day, and increased to 8 mg/day in Week 4. From Week 5 up to 16, the dose will be increased at minimum intervals of one week between titration steps until sufficient efficacy is obtained, according to individual clinical response and tolerability (the dose may be titrated up to 16 mg/day). In Week 16 and further, treatment dose at Week 16 will be continuously administered up to Week 52. If insufficient efficacy is judged in a subject during treatment, or unable to maintain the dose due to adverse event, the treatment dose may be changed. The dose is down tapered according to the maintenance dose at Week 52 (or withdrawal).

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-09
Primary Completion
2009-03-01
Completion
2009-03-10

Countries

  • Japan

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00434304 on ClinicalTrials.gov