CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 287 enrolled
Drug / intervention
Rotigotine +1 moredrug
Likely dose
Rotigotine 2mgfrom 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/NCT00474058
NCT00474058Phase 3Completed
CompareCT.gov

Phase 3B, Multicenter, Multinational, Double-Blind, Placebo Controlled, 2-Arm Trial to Evaluate the Effect of the 24-Hour Transdermal Delivery of Rotigotine on the Control of Early Morning Motor Function, Sleep Quality, Nocturnal Symptoms, and Non-Motor Symptoms in Subjects With Idiopathic Parkinson's Disease

UCB Pharma·interventional·Posted May 16, 2007·Updated Jun 22, 2015

In Brief

A Phase 3 clinical trial evaluating Rotigotine and Placebo for Parkinson's Disease. Completed, enrolled 287 participants across 47 sites in 12 countries.

Detailed Summary

The objective of this trial is to assess the effects of transdermal rotigotine on the control of early morning motor function and sleep disorders compared to placebo in subjects with idiopathic Parkinsons´s disease. In addition, effects of rotigotine on specific nocturnal and non-motor symptoms of Parkinson´s disease will be evaluated.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson's Disease
CountriesAustralia, Austria, Finland, Germany, Hungary, Italy, New Zealand, Poland, South Africa, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 16, 2007
Enrollment StartMay 1, 2007
Primary CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 19.1 years ago

Interventions

Rotigotinedrug

Rotigotine transdermal patches: 10cm2 (2mg/24h); 20cm2 (4mg/24h); 30cm2 (6mg/24h); 40cm2 (8mg/24h) Optimal dosing: The maximum Rotigotine dose allowed is 16mg/24h

Placeboother

Placebo transdermal patches