drugset / Trial / NCT01646255

Rotigotine Versus Placebo, A Study To Evaluate The Efficacy In Advanced Stage Idiopathic Parkinson's Disease Patients

NCT01646255 ↗

Phase 3 Completed 346 enrolled UCB Pharma UCB Trading (Shanghai) Co. Ltd. · collab
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2012-07
Primary completion
2014-10
Completion
2014-10

Outcome

Met primary endpoint

paper Rotigotine significantly reduced "off" time vs placebo (LS mean [95% CI] treatment difference: -1.20 h/day [-1.83, -0.57]; p = 0.0002) PMID 28827011 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Rotigotine Unknown 4 mg Other
Subject Rotigotine Unknown 6 mg Other
Subject Rotigotine Unknown 8 mg Other
Subject Rotigotine Unknown 16 mg Other
Background L-dopa Peptide — —

Indications