An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advance-Stage Parkinson's Disease
- Registration Number
- NCT00594386
- Lead Sponsor
- UCB Pharma
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 258
- Subjects who have completed six months of maintenance treatment in the SP650 double-blind trial
- Subjects who had an ongoing serious adverse event from the SP650 double-blind trial that was assessed as related to study medication
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Rotigotine Rotigotine -
- Primary Outcome Measures
Name Time Method Number of Subjects With at Least One Adverse Event During This Open-label Extension Study 6 years Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
- Secondary Outcome Measures
Name Time Method Number of Subjects Who Withdrew From the Trial Due to an Adverse Event. 6 years Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Mean Epworth Sleepiness Scale Score During the Open-label Extension. Visit 11 (end of year 1), Visit 15 (end of year 2), Visit 19 (end of year 3), Visit 23 (end of year 4), Visit 27 (end of year 5), Visit 31 (end of year 6), End of Treatment (last study visit or early withdrawal visit) The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions. The total ESS score is the sum of 8 item-scores and can range between 0 and 24. The higher the score, the higher the person's level of daytime sleepiness.