CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 381 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.

Search/NCT00599196
NCT00599196Phase 3Completed
CompareCT.gov

An Open-Label Extension to the Double-Blind SP513 Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Early-Stage Idiopathic Parkinson's Disease

UCB Pharma·interventional·Posted Jan 23, 2008·Updated Oct 2, 2014

In Brief

A Phase 3 clinical trial evaluating Rotigotine for Early Stage Parkinson's Disease. Completed, enrolled 381 participants across 63 sites in 20 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 early-stage idiopathic Parkinson's disease

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEarly Stage Parkinson's Disease
CountriesAustralia, Austria, Belgium, Croatia, Czechia, Finland, France, Germany, Hungary, Israel, Italy, Netherlands, New Zealand, Norway, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 23, 2008
Enrollment StartAug 1, 2002
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 18.4 years ago

Interventions

Rotigotinedrug

Rotigotine trans-dermal patches, once daily: 10 cm2 (2 mg/24 hours); 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); Optimal dosing: During the first year: The maximum Rotigotine dose allowed is 8 mg/24 hours. After the first year: allowed dose increase of rotigotine up to a maximum of 16 mg/24 hours.