An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Early-Stage Parkinson's Disease. (SP512OL)
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label Extension to the Double-Blind SP512 Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Early-Stage Idiopathic Parkinson's Disease.|
- Number of Subjects With at Least One Adverse Event During This Open-label Extension Study [ Time Frame: 7 years ] [ Designated as safety issue: No ]Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
- Number of Subjects Who Withdrew From the Trial Due to an Adverse Event. [ Time Frame: 7 years ] [ Designated as safety issue: No ]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. [ Time Frame: Visit 9 (end of year 1), Visit 13 (end of year 2), Visit 17 (end of year 3), Visit 21(end of year 4), Visit 25 (end of year 5), Visit 29 (end of year 6), End of Treatment (last study visit or early withdrawal visit) ] [ Designated as safety issue: No ]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.
|Study Start Date:||June 2002|
|Study Completion Date:||November 2008|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
Rotigotine trans-dermal 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)
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.
Other Name: Neupro
This is the open-label extension to the randomized, double-blind, placebo-controlled SP512 trial that assessed the efficacy and safety and tolerability of the Rotigotine patch in subjects with early-stage idiopathic Parkinson's Disease.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00594165
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|Study Director:||UCB Clinical Trial Call Center||+1 877 822 9493 (UCB)|