drugset / Trial / NCT01646255
Rotigotine Versus Placebo, A Study To Evaluate The Efficacy In Advanced Stage Idiopathic Parkinson's Disease Patients
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — | — |