CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 295 enrolled
Drug / intervention
Requip PRdrug
Likely dose
Requip PR 8mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01536574
NCT01536574Phase 3Completed
CompareCT.gov

An Open Label Extension Study With REQUIP PR for Subjects From Study ROP111528

GlaxoSmithKline·interventional·Posted Feb 22, 2012·Updated Aug 13, 2018

In Brief

A Phase 3 clinical trial evaluating Requip PR for Parkinson Disease. Completed, enrolled 295 participants across 18 sites.

Detailed Summary

This open label extension study allows assessment of the long term safety profile of REQUIP PR in subjects who have completed 24 weeks of randomised treatment in study ROP111528. Subjects must not have a break in study medication between completing the feeder study and entering extension study, treatment must be continuous. Subjects will be dispensed down-titration medication at the study completion/early withdrawal visit and should be scheduled to return for a follow up visit 4 to 14 days after the last dose of study medication.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson Disease
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 22, 2012
Enrollment StartSep 2, 2010
Primary CompletionMar 1, 2012
Study CompletionMar 28, 2012
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 14.4 years ago

Interventions

Requip PRdrug

Eligible patients will be dispensed medication to uptitrate their REQUIP PR dose (2, 4, 6, 8mg respectively) during the first 4 weeks of treatment. During the 24 week treatment phase, the subjects dose will be adjusted according to the recommended schedule to achieve symptomatic control.