CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 249 enrolled
Drug / intervention
Rotigotine +1 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/NCT01646268
NCT01646268Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study Of The Efficacy And Safety Of The Rotigotine Transdermal Patch In Chinese Subjects With Early-stage Idiopathic Parkinson's Disease

UCB Pharma·interventional·Posted Jul 20, 2012·Updated Aug 11, 2015

In Brief

A Phase 3 clinical trial evaluating Rotigotine and Placebo Patch for IDIOPATHIC PARKINSON'S DISEASE. Completed, enrolled 249 participants across 24 sites.

Detailed Summary

The primary objective is to demonstrate that the Rotigotine transdermal patch is efficacious in Chinese subjects with early-stage idiopathic Parkinson's disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIDIOPATHIC PARKINSON'S DISEASE
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 20, 2012
Enrollment StartJul 1, 2012
Primary CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 14.0 years ago

Interventions

Rotigotinedrug

Transdermal Patch Content: 2 mg /24 h (10 cm\^2), 4 mg /24 h (20 cm\^2), 6 mg /24 h (30 cm\^2), 8 mg /24 h (40 cm\^2) For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period

Placebo Patchdrug

Transdermal Patch Size: 10 cm\^2, 20 cm\^2, 30 cm\^2, 40 cm\^2 Subjects randomized to placebo will receive matching placebo patches