Parkinson's Disease Clinical Trial
Official title:
Phase 3B, Multicenter, Multinational, Double-Blind, Placebo Controlled, 2-Arm Trial to Evaluate the Effect of the 24-Hour Transdermal Delivery of Rotigotine on the Control of Early Morning Motor Function, Sleep Quality, Nocturnal Symptoms, and Non-Motor Symptoms in Subjects With Idiopathic Parkinson's Disease
The objective of this trial is to assess the effects of transdermal rotigotine on the control of early morning motor function and sleep disorders compared to placebo in subjects with idiopathic Parkinsons´s disease. In addition, effects of rotigotine on specific nocturnal and non-motor symptoms of Parkinson´s disease will be evaluated.
The objective of this trial is to assess the effects of rotigotine on the control of early
morning motor function and sleep disorders compared to placebo in subjects with idiopathic
Parkinsons´s disease. In addition, effects of rotigotine on specific nocturnal and non-motor
symptoms of Parkinson´s disease will be evaluated.
After a Screening Period of up to 28 days subjects will be hospitalized for two nights.
After the second overnight stay, subjects will be randomly assigned either to rotigotine
patch or placebo patch. Afterwards patients will be titrated to their optimal dose. After
subjects have reached their optimal dose (or the highest dose) they will be maintained on
this dose for a certain period. At the end of maintenance the subjects will be hospitalized
for two nights. Afterwards the doses will be continuously decreased.
Efficacy will be assessed by application of sleep quality scores, motor examination scores,
and scores to evaluate non-motor symptoms of Parkinsons. Safety assessments include adverse
events, 12-lead electrocardiograms, blood pressure and heart rate assessments, and
laboratory checks.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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