At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 87 enrolled
Drug / intervention
Rotigotinedrug
Likely dose
Rotigotine 16 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, Multicenter, Multinational Study to Assess the Feasibility of Switching Therapy From Pramipexole or Ropinirole to the Rotigotine Transdermal System and Its Effect on Motor and Non-Motor Symptoms in Subjects With Advanced Idiopathic Parkinson's Disease Phase 4
In Brief
A Phase 4 clinical trial evaluating Rotigotine for Advanced Idiopathic Parkinson's Disease. Completed, enrolled 87 participants across 21 sites in 5 countries.
Detailed Summary
The purpose of this study is to assess the safety and feasibility of switching subjects with advanced Parkinson's Disease (PD) from Pramipexole or Ropinirole to Rotigotine and to assess the effects of Rotigotine on motor and non-motor symptoms of Parkinson's Disease in subjects switched from previous treatment with either Pramipexole or Ropinirole.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Idiopathic Parkinson's Disease
CountriesMalaysia, Singapore, South Korea, Taiwan, United States
CollaboratorsOtsuka Pharmaceutical Co., Ltd.
Timeline
Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2012
First PostedOct 2012
Primary CompletionMar 2013
TodayJul 2026
First PostedOct 22, 2012
Enrollment StartSep 1, 2012
Primary CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 13.7 years ago
Interventions
Rotigotinedrug
Rotigotine up to 16 mg / 24 hours, 4 weeks.