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A Study to Evaluate the Efficacy of 18 to 24mg/Day Ropinirole Controlled Release (CR) Tablets in Early and Advanced Parkinson's Disease (PD) Patients.

NCT01929317 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2018-06-20

Study results available
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Summary

This study is a Phase III, multicentre, randomized, initial double-blind study with subsequent open label phases. The study will havea screening phase (4 weeks), a dose increase effect verification phase (12 weeks), a down titration 1 phase (1 week), a long-term phase (39 weeks), down titration 2 phase (1 to 2 weeks) and a follow up phase. Subjects will be assigned to Ropinirole CR high-dose group or Ropinirole CR maintenance group at a ratio of 3:1. This study is being conducted to evaluate the efficacy (effect of increasing Ropinirole dose from 16 mg/day to 18-24 mg/day) of the Ropinirole CR tablets in early and advanced PD patients who have not achieved an optimal therapeutic response with marketed Ropinirole Immediate release (IR) (15 mg/day) or marketed Ropinirole CR (16 mg/day) formulations.

Conditions

  • Parkinson Disease

Interventions

DRUG

Ropinirole CR 2mg tablet

Ropinirole CR 2mg tablets will be supplied as white oval film-coated tablets.

DRUG

Ropinirole CR 8mg tablet

Ropinirole CR 8mg tablets will be supplied as white oval film-coated tablets.

DRUG

Ropinirole CR matching Placebo tablet

Ropinirole CR matching Placebo tablet tablets (containing no active ingredients) indistinguishable in appearance from Ropinirole CR 2 mg tablets.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-28
Primary Completion
2014-09-16
Completion
2015-06-09

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 NCT01929317 on ClinicalTrials.gov