CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 349 enrolled
Drug / intervention
Rotigotine +1 moredrug
Likely dose
Rotigotine 8 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/NCT01300819
NCT01300819Phase 4Completed
CompareCT.gov

Multicenter, Double-blind, Placebo-controlled, Parallel-group, Phase IV Study to Assess the Effect of Rotigotine on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease

UCB Pharma·interventional·Posted Feb 23, 2011·Updated May 9, 2014

In Brief

A Phase 4 clinical trial evaluating Placebo and Rotigotine for Idiopathic Parkinson's Disease. Completed, enrolled 349 participants across 87 sites in 12 countries.

Detailed Summary

The primary objective of this study was to demonstrate that Rotigotine improves non-motor symptoms compared to Placebo in subjects with Parkinson's Disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIdiopathic Parkinson's Disease
CountriesAustria, Belgium, Bulgaria, Czechia, France, Germany, Hungary, Italy, Romania, Slovakia, Spain, Switzerland
Collaborators--

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 23, 2011
Enrollment StartFeb 1, 2011
Primary CompletionOct 1, 2012
Study CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 15.4 years ago

Interventions

Placeboother

Placebo patches of 2, 4, 6 \& 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose was up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose was reached. Maximal dose was 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients. Optimal or maximal dose was maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.

Rotigotinedrug

Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose was up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose was reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients. Optimal or maximal dose was maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.