NCT01536015

Effect of Rotigotine on Motor Symptoms in Patients With Advanced Parkinson's Disease (PD) With Motor Fluctuations and Symptoms of Gastrointestinal Dysfunction

A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Effect of Rotigotine on Motor Symptoms in Patients With Advanced Parkinson's Disease With Motor Fluctuations and Symptoms of Gastrointestinal Dysfunction

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose is to demonstrate superiority of Rotigotine over Placebo on motor symptoms when used in subjects with symptoms of Gastrointestinal Dysfunction. Hypothesis: Rotigotine will decrease OFF time compared to Placebo.

Conditions

• Advanced Parkinson's Disease

Interventions

Type	Name	Description
DRUG	Rotigotine	Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours Dosage and Frequency: One patch every 24 hours Duration: 10 weeks
DRUG	Placebo	Frequency: One patch applied every 24 hours Duration: 10 weeks

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2012-02-20
• Last updated: 2014-08-01
• Results posted: 2014-08-01

Locations

26 sites across 1 country: United States