At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 395 enrolled
Drug / intervention
Rotigotinedrug
Likely dose
Rotigotine 4 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.
An Open-Label Extension to the Double-Blind SP515 (NCT00244387) Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Advanced-Stage Idiopathic Parkinson's Disease Who Are Not Well Controlled on L-Dopa
In Brief
A Phase 3 clinical trial evaluating Rotigotine for Advanced Stage Parkinson's Disease. Completed, enrolled 395 participants across 53 sites in 17 countries.
Detailed Summary
The objective of this open-label extension is to assess the safety and tolerability of long-term treatment of the rotigotine patch in subjects with advanced-stage idiopathic Parkinson's disease
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Stage Parkinson's Disease
CountriesAustralia, Austria, Croatia, Czechia, Finland, France, Germany, Hungary, Israel, Italy, New Zealand, Norway, Poland, South Africa, Spain, Sweden, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2004
First PostedJul 2007
Primary CompletionDec 2008
TodayJul 2026
First PostedJul 17, 2007
Enrollment StartAug 1, 2004
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 19.0 years ago
Interventions
Rotigotinedrug
Rotigotine trans-dermal patches once daily: 20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours) 50 cm2 (10 mg/24 hours) 60 cm2 (12 mg/24 hours) 70 cm2 (14 mg/24 hours) 80 cm2 (16 mg/24 hours)