IDIOPATHIC PARKINSON'S DISEASE Clinical Trial
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
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
n/a
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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