Placebo-controlled Study in Patients With Parkinson's Disease to Evaluate the Effect of Rotigotine on Non-motor Symptoms

Phase 4 Completed 349 enrolled UCB Pharma

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective of this study was to demonstrate that Rotigotine improves non-motor symptoms compared to Placebo in subjects with Parkinson's Disease.

Timeline

Start: 2011-02
Primary completion: 2012-10
Completion: 2012-11

Outcome

Missed primary endpoint

paper the treatment difference was not statistically significant (-3.58; 95% confidence interval -8.43, 1.26; P = 0.147). PMID 26095948 ↗

Publications

Antonini A, Bauer L, Dohin E, Oertel WH, Rascol O, Reichmann H, Schmid M, Singh P, Tolosa E, Chaudhuri KR. Effects of rotigotine transdermal patch in patients with Parkinson's disease presenting with non-motor symptoms - results of a double-blind, randomized, placebo-controlled trial. Eur J Neurol. 2015 Oct;22(10):1400-7. doi: 10.1111/ene.12757. Epub 2015 Jun 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rotigotine	Unknown	2 mg	Other
Subject	Rotigotine	Unknown	4 mg	Other
Subject	Rotigotine	Unknown	6 mg	Other
Subject	Rotigotine	Unknown	8 mg	Other
Subject	Rotigotine	Unknown	16 mg	Other