CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 514 enrolled
Drug / intervention
Rotigotine +4 moredrug
Likely dose
Rotigotine 2 mgfrom 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/NCT00522379
NCT00522379Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Double-blind, Placebo-controlled, 5-arm, Parallel-group Trial to Assess Rotigotine Transdermal System Dose Response in Subjects With Advanced-stage Parkinson's Disease

UCB Pharma·interventional·Posted Aug 29, 2007·Updated Oct 27, 2014

In Brief

A Phase 3 clinical trial evaluating Rotigotine and Placebo for Parkinson's Disease. Completed, enrolled 514 participants across 77 sites in 5 countries.

Detailed Summary

The purpose of this study is to show Rotigotine dose response at four doses of Rotigotine used with L-dopa in treating advanced stage Parkinson's disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson's Disease
CountriesChile, India, Mexico, Peru, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 29, 2007
Enrollment StartJul 1, 2007
Primary CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 18.8 years ago

Interventions

Rotigotinedrug

2 mg/24 hr (one 10 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks

Rotigotinedrug

4 mg/24 hr (one 20 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks

Placeboother

Placebo transdermal patch applied daily

Rotigotinedrug

6 mg/24 hr (one 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks

Rotigotinedrug

8 mg/24 hr (two 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks