Conditions: Parkinson's Disease
Keywords: Rotigotine Rotigotine nasal spray Efficacy, safety and tolerability Parkinson's disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 82
Healthy volunteers: no

Brief 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.

Detailed description:
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.

Arms:
arm 1: Placebo nasal spray 1 - 4 puffs arm 2: Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine) arm 3: Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine) arm 4: Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine) arm 5: Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)

Interventions: intervention 1: Rotigotine nasal spray intervention 2: Placebo
Intervention descriptions: intervention 1: Rotigotine- HCl 2.5mg/mL nasal spray, dosage per puff of 275µg per 110µg administered in up to 4 deliveries intervention 2: placebo nasal spray 1, 2 3, and 4 puffs

Protocol document: