Efficacy, Safety and Tolerability of Rotigotine Nasal Spray for the Acute Treatment of Parkinson Symptoms

Efficacy, Safety and Tolerability of Rotigotine Nasal Spray for the Acute Treatment of Parkinson Symptoms

A Double-Blind, Placebo-Controlled, Parallel-Group, Proof of Concept Trial to Assess the Tolerability, Safety, and Efficacy of Rotigotine Nasal Spray for the Acute Treatment of "OFF" Symptoms in Subjects With Advanced-Stage, Idiopathic Parkinson Disease

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 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.

Rotigotine- HCl 2.5mg/mL nasal spray, dosage per puff of 275µg per 110µg administered in up to 4 deliveries

Change From Baseline at 24 Minutes Post-dose in Unified Parkinson Disease Rating Scale (UPDRS) Part III Motor Examination

The Unified Parkinson's Disease Rating Scale (UPDRS) is a scale for the assessment of function in Parkinson's disease. UPDRS Part III measures Motor Examination. Range: 0 (Best score possible) to 56 (Worst score possible) Change = 24 minute value minus baseline value.

One-minute tapping rate will be calculated as the number of times a subject could tap on two 4 x 4 cm marks placed on a board 30 cm apart during 1 minute (30 cm measured from the inner border of the two boxes).

Subjects reversing from "off" to "on" following initiation of treatment. "On" and "off" state refer to periods where Parkinson's disease symptoms are not present ("on") and periods where symptoms are present ("off"); the "on"/"off" determination at each assessment timepoint was made by the investigator.

Number of minutes to first reversal of symptoms from "off" to "on". Estimated via Kaplan-Meier estimation method. "On" and "off" state refer to periods where Parkinson's disease symptoms are not present ("on") and periods where symptoms are present ("off"); the "on"/"off" determination at each assessment timepoint was made by the investigator.

Inclusion Criteria: Male and female subjects with idiopathic Parkinson's disease for at least 3 years in duration At least 30 years of age Exclusion Criteria: Patients with atypical Parkinson's or clinically relevant concomitant diseases or medical conditions