NCT01723904

A Phase 3b, Open-Label, Safety and Efficacy Study of Rotigotine as Add-On Therapy With Low Doses of Pramipexole or Ropinirole in Patients With Advanced Parkinson's Disease

An Open-Label Study to Investigate the Safety and Efficacy of Rotigotine Add-On Therapy With Low Doses of Pramipexole or Ropinirole in Patients With Advanced Parkinson's Disease Phase 3B

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: UCB BIOSCIENCES GmbH · Industry
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is to investigate the safety and efficacy of Rotigotine add-on therapy with low doses of Pramipexole or Ropinirole in patients with advanced-stage Parkinson's Disease (PD) who have insufficient response to L-dopa and low doses dopamine receptor agonists.

Conditions

• Advanced Parkinson's Disease

Interventions

Type	Name	Description
DRUG	Rotigotine	Application of Rotigotine up to 8 mg/24 h patches for 24 hours.

Timeline

• Start date: 2012-10-01
• Primary completion: 2013-03-01
• Completion: 2013-04-01
• First posted: 2012-11-08
• Last updated: 2014-06-03
• Results posted: 2014-06-03

Locations

22 sites across 5 countries: Australia, Malaysia, Singapore, South Korea, Taiwan