An Open-Label Extension Trial to Assess the Safety and Tolerability of Long Term Treatment of Rotigotine in Subjects With Idiopathic Parkinson's Disease
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|ClinicalTrials.gov Identifier: NCT00505687|
Recruitment Status : Completed
First Posted : July 23, 2007
Results First Posted : January 12, 2010
Last Update Posted : October 2, 2014
|Condition or disease||Intervention/treatment||Phase|
|Idiopathic Parkinson's Disease||Drug: Rotigotine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||186 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Multinational, Phase 3b, Open-Label Extension Trial to Assess the Safety and Tolerability of Long-Term Treatment of Rotigotine Patch in Subjects With Idiopathic Parkinson's Disease|
|Study Start Date :||February 2005|
|Primary Completion Date :||December 2008|
|Study Completion Date :||December 2008|
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)
The maximum rotigotine dose allowed is 16 mg/24 hours.
Other Name: Neupro
- Number of Subjects With at Least One Adverse Event During This Open-label Extension Study [ Time Frame: four years ]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: four 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. [ Time Frame: Visit 6 (post year 1), Visit 10 (post year 2), Visit 14 (post year 3), 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00505687
Show 26 Study Locations
|Study Director:||UCB Clinical Trial Call Center||+1 877 822 9493 (UCB)|