NCT00594386

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

An Open-Label Extension to the Double-Blind SP650 Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Advanced-Stage Idiopathic Parkinson's Disease.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 258 (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-controlled SP650 trial that assessed the efficacy and safety and tolerability of the Rotigotine patch in subjects with advanced-stage idiopathic Parkinson's Disease who are not well-controlled on Levodopa.

Conditions

• 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: During the first year: The maximum Rotigotine dose allowed is 6 mg/24 hours. After the first year: Allowed dose increase of Rotigotine up to a maximum of 16 mg/24 hours.

Timeline

• Start date: 2002-08-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2008-01-15
• Last updated: 2014-10-02
• Results posted: 2009-12-18

Locations

41 sites across 2 countries: United States, Canada