At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 186 enrolled
Drug / intervention
Rotigotinedrug
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.
A Multicenter, Multinational, Phase 3b, Open-Label Extension Trial to Assess the Safety and Tolerability of Long-Term Treatment of Rotigotine Patch in Subjects With Idiopathic Parkinson's Disease
In Brief
A Phase 3 clinical trial evaluating Rotigotine for Idiopathic Parkinson's Disease. Completed, enrolled 186 participants across 26 sites in 8 countries.
Detailed Summary
The objective of this open-label extension is to assess the safety and tolerability of long-term treatment of rotigotine in subjects with idiopathic PD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIdiopathic Parkinson's Disease
CountriesAustria, Germany, Israel, Italy, South Africa, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2005
First PostedJul 2007
Primary CompletionDec 2008
TodayJul 2026
First PostedJul 23, 2007
Enrollment StartFeb 1, 2005
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 18.9 years ago
Interventions
Rotigotinedrug
Rotigotine transdermal patches: 10 cm2 (2 mg/24 hours); 20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours) Optimal dosing: The maximum rotigotine dose allowed is 16 mg/24 hours.