Efficacy, Safety and Tolerability of Rotigotine Nasal Spray for the Acute Treatment of Parkinson Symptoms
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.
The Use of Rotigotine for Treatment of Reducing Signs and Symptoms of Fibromyalgia in Adults.
This trial is to investigate the efficacy and safety of rotigotine as compared to placebo in
reducing signs and symptoms of fibromyalgia syndrome. The effects of rotigotine on pain,
sleep, general activity, mood, and quality of life, and the use of rescue medication to
treat pain will be assessed.
Randomized Evaluation of the 24-Hour Coverage: Efficacy of Rotigotine
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.
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