At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 90 enrolled
Drug / intervention
Rotigotinedrug
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.
An Open-Label Study to Investigate the Safety and Efficacy of Rotigotine Add-On Therapy With Low Doses of Pramipexole or Ropinirole in Patients With Advanced Parkinson's Disease Phase 3B
In Brief
A Phase 3 clinical trial evaluating Rotigotine for Advanced Parkinson's Disease. Completed, enrolled 90 participants across 22 sites in 5 countries.
Detailed Summary
This study is to investigate the safety and efficacy of Rotigotine add-on therapy with low doses of Pramipexole or Ropinirole in patients with advanced-stage Parkinson's Disease (PD) who have insufficient response to L-dopa and low doses dopamine receptor agonists.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Parkinson's Disease
CountriesAustralia, Malaysia, Singapore, South Korea, Taiwan
CollaboratorsOtsuka Pharmaceutical Co., Ltd.
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2012
First PostedNov 2012
Primary CompletionMar 2013
Study CompletionApr 2013
TodayJul 2026
First PostedNov 8, 2012
Enrollment StartOct 1, 2012
Primary CompletionMar 1, 2013
Study CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 13.7 years ago
Interventions
Rotigotinedrug
Application of Rotigotine up to 8 mg/24 h patches for 24 hours.