A Trial to Evaluate the Effects of Rotigotine Transdermal Patch on Early Morning Motor Impairment and Sleep Disorders Idiopathic Parkinson's Disease
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|ClinicalTrials.gov Identifier: NCT00243945|
Recruitment Status : Completed
First Posted : October 25, 2005
Last Update Posted : September 25, 2014
The objective of this trial is to assess the effect of rotigotine (SPM 962) on the control of early morning motor impairment and sleep disorders in subjects with idiopathic PD.
Subjects who meet eligibility criteria will begin treatment with rotigotine transdermal patches. Trial medication will be titrated to an optimal daily dose, or to the maximal dose. Following a Titration period of up to 8 weeks, subjects will be maintained on the optimal or maximal dose for 4 weeks. After the Maintenance period, subjects will have the option to enter into an open-label extension study.
The first subject was enrolled in December 2004. The last subject was enrolled in April 2005 and the last subject visit was conducted in July 2005. This study is now closed
|Condition or disease||Intervention/treatment||Phase|
|IDIOPATHIC PARKINSON'S DISEASE||Drug: Rotigotine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||58 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3b, Open-Label, Multicenter, Multinational Trial to Evaluate the Effects of Rotigotine Transdermal Patch on Early Morning Motor Impairment and Sleep Disorders in Patients With Idiopathic Parkinson's Disease|
|Study Start Date :||December 2004|
|Actual Primary Completion Date :||July 2005|
|Actual Study Completion Date :||July 2005|
- Motor performance; Sleep disorders; Clinical Global Impression; Patient Global Impression; Safety & Tolerability
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): NCT00243945
|Study Director:||UCB Clinical Trial Call Center||UCB Pharma|