NCT00599196

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

An Open-Label Extension to the Double-Blind SP513 Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Early-Stage Idiopathic Parkinson's Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 381 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 30 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 early-stage idiopathic Parkinson's disease

Detailed description

This is the open-label extension to the randomized, double-blind, placebo- and ropinirole-controlled SP513 trial that assessed the efficacy and safety and tolerability of the Rotigotine patch in subjects with early-stage idiopathic Parkinson's Disease

Conditions

• Early Stage Parkinson's Disease

Interventions

Type	Name	Description
DRUG	Rotigotine	Rotigotine trans-dermal patches, once daily: 10 cm2 (2 mg/24 hours); 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); Optimal dosing: During the first year: The maximum Rotigotine dose allowed is 8 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: 2008-01-23
• Last updated: 2014-10-02
• Results posted: 2010-01-18

Locations

63 sites across 20 countries: Australia, Austria, Belgium, Croatia, Czechia, Finland, France, Germany, Hungary, Israel, Italy, Netherlands, New Zealand, Norway, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom