Efficacy, Safety and Tolerability of Rotigotine Nasal Spray for the Acute Treatment of Parkinson Symptoms
Status:
Completed
Trial end date:
2006-06-01
Target enrollment:
Participant gender:
Summary
The objective of this trial is to evaluate safety and efficacy of rotigotine nasal spray (SPM
952) in a single dose application scheme.
Subjects will undergo a 2 - 28 days screening period in which eligibility criteria will be
checked. Subjects will then be hospitalized for one night. In the morning of the next day,
subjects will be randomly assigned either to rotigotine or placebo nasal spray and will then
receive a single dose of trial medication. Safety assessments after application include
adverse events, 12-lead electrocardiograms, blood pressure and heart rate assessments, and
laboratory checks. Efficacy will be assessed by application of motor examination scores.
The first subject is planned to be enrolled in February 2006. The last subject is planned to
be enrolled in May 2006. Last subject out is expected for August 2006.