NCT00505687

An Open-Label Extension Trial to Assess the Safety and Tolerability of Long Term Treatment of Rotigotine in Subjects With Idiopathic Parkinson's Disease

A Multicenter, Multinational, Phase 3b, Open-Label Extension Trial to Assess the Safety and Tolerability of Long-Term Treatment of Rotigotine Patch in Subjects With Idiopathic Parkinson's Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 186 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 31 Years
• Healthy volunteers: Not accepted

Summary

The objective of this open-label extension is to assess the safety and tolerability of long-term treatment of rotigotine in subjects with idiopathic PD.

Detailed description

This is the open-label extension to the open-label trials SP824 (NCT00242008), SP825 (NCT00243971), and SP826 (NCT00243945) that assessed the efficacy and safety and tolerability of rotigotine in subjects with idiopathic Parkinson's Disease.

Conditions

• Idiopathic Parkinson's Disease

Interventions

Type	Name	Description
DRUG	Rotigotine	Rotigotine transdermal patches: 10 cm2 (2 mg/24 hours); 20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours) Optimal dosing: The maximum rotigotine dose allowed is 16 mg/24 hours.

Timeline

• Start date: 2005-02-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2007-07-23
• Last updated: 2014-10-02
• Results posted: 2010-01-12

Locations

26 sites across 8 countries: United States, Austria, Germany, Israel, Italy, South Africa, Spain, United Kingdom