Completed
PHASE3
INTERVENTIONAL
NCT01646255
Rotigotine Versus Placebo, A Study To Evaluate The Efficacy In Advanced Stage Idiopathic Parkinson's Disease Patients
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
The primary objective of this study was to demonstrate that Rotigotine transdermal patch is efficacious in Chinese subjects with advanced-stage Idiopathic Parkinson's Disease as an adjuvant therapy.
Detailed Description
The study included a maximum 4-week Screening Period, a maximum 7-week Titration Period for advanced-stage Parkinson's disease, 12-week Maintenance Period, a maximum 12-day De-escalation Period for advanced-stage Parkinson's Disease and 30-day Safety Follow-Up Period. The maximum study duration for an individual subject with advanced-stage Parkinson's disease was 27 weeks.
Interventions
Name:
Rotigotine
Type:
DRUG
Description:
Transdermal Patch
Content:
4 mg /24 h (20 cm\^2), 6 mg /24 h (30 cm\^2), 8 mg /24 h (40 cm\^2)
For advanced-stage Parkinson's Disease, subjects received Rotigotine patches in escalating weekly dose (starting with daily doses 4 mg/24 h to 16 mg/24 h) for a maximum 7-week Titration Period, then 12 week maintenance period
Name:
Placebo Patch
Type:
DRUG
Description:
Transdermal Patch
Size:
20 cm\^2, 30 cm\^2, 40 cm\^2
Subjects randomized to placebo received matching placebo patches
Name:
L-dopa
Type:
DRUG
Description:
Subject must be on a stable dose of L-dopa (either short-acting or sustained release \[in combination with benserazide or carbidopa\]) of at least 200 mg/day, administered in at least 2 intakes, for at least 28 days prior to Baseline.
Primary Outcomes
Measure:
Absolute Change in Absolute Time Spent 'Off' From Baseline to the End of Double-blind Maintenance Period
TimeFrame:
From Baseline (Week 0) to end of Maintenance Period (up to Week 12)
Description:
A subject has been considered "off" when he/she began to lose the optimum effects of anti-Parkinson's medication. A negative mean indicates a reduction of the time off during the conduct of the study
Trial Information
NCT ID
NCT01646255
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE3
Sponsor
UCB Pharma
Last Updated
December 15, 2025