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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Drug: Rotigotine nasal spray
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo 1<br>Placebo nasal spray 1 - 4 puffs | Other: Placebo<br>* placebo nasal spray 1, 2 3, and 4 puffs<br>|
| Experimental: Rotigotine 1<br>Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine) | Drug: Rotigotine nasal spray<br>* Rotigotine- HCl 2.5mg/mL nasal spray, dosage per puff of 275µg per 110µg administered in up to 4 deliveries<br>* Other names: SPM 952;|
| Experimental: Rotigotine 2<br>Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine) | Drug: Rotigotine nasal spray<br>* Rotigotine- HCl 2.5mg/mL nasal spray, dosage per puff of 275µg per 110µg administered in up to 4 deliveries<br>* Other names: SPM 952;|
| Experimental: Rotigotine 3<br>Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine) | Drug: Rotigotine nasal spray<br>* Rotigotine- HCl 2.5mg/mL nasal spray, dosage per puff of 275µg per 110µg administered in up to 4 deliveries<br>* Other names: SPM 952;|
| Experimental: Rotigotine 4<br>Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine) | Drug: Rotigotine nasal spray<br>* Rotigotine- HCl 2.5mg/mL nasal spray, dosage per puff of 275µg per 110µg administered in up to 4 deliveries<br>* Other names: SPM 952;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Who Complete the Trial |  | 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, and 24 minutes post-dose | 
| Change From Baseline to 34 Minutes Post-dose in Tapping Rate (Taps/Min) | 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). | Baseline and 34 minutes post-dose | 
| Success Rate (Percentage of Subjects Achieving Off Reversals) | 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. | Up to 6 hours post-dose | 
| Time of First Off Reversal | 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. | Up to 6 hours post-dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's disease, Rotigotine, Rotigotine nasal spray, Efficacy, safety and tolerability