NCT00501969

An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advanced-Stage Parkinson's Disease

An Open-Label Extension to the Double-Blind SP515 (NCT00244387) Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Advanced-Stage Idiopathic Parkinson's Disease Who Are Not Well Controlled on L-Dopa

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 395 (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 the rotigotine patch in subjects with advanced-stage idiopathic Parkinson's disease

Detailed description

This is the open-label extension to the randomized, double-blind, placebo-and active controlled SP515 (NCT00244387) trial that assessed the efficacy and safety and tolerability of the Rotigotine patch in subjects with advanced-stage idiopathic Parkinson's Disease that were not well-controlled on levodopa

Conditions

• Advanced Stage Parkinson's Disease

Interventions

Type	Name	Description
DRUG	Rotigotine	Rotigotine trans-dermal patches once daily: 20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours) 50 cm2 (10 mg/24 hours) 60 cm2 (12 mg/24 hours) 70 cm2 (14 mg/24 hours) 80 cm2 (16 mg/24 hours)

Timeline

• Start date: 2004-08-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2007-07-17
• Last updated: 2014-10-02
• Results posted: 2010-01-12

Locations

53 sites across 17 countries: Australia, Austria, Croatia, Czechia, Finland, France, Germany, Hungary, Israel, Italy, New Zealand, Norway, Poland, South Africa, Spain, Sweden, United Kingdom