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

Phase 2

Completed

• Conditions: Parkinson's Disease
• Interventions: Drug: Rotigotine nasal spray; Other: Placebo

• Registration Number: NCT00296192
• Lead Sponsor: UCB Pharma

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.

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-02-22
• Study First Submitted QC: 2006-02-22
• Study First Posted: 2006-02-24
• Primary Completion: 2006-06
• Study Completion: 2006-06
• Results First Submitted: 2009-07-30
• Results First Submitted QC: 2010-01-05
• Results First Posted: 2010-01-29
• Status Verified: 2011-02
• Last Update Submitted: 2014-09-24
• Last Update Posted: 2014-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rotigotine 2	Rotigotine nasal spray	Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)
Rotigotine 4	Rotigotine nasal spray	Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)
Rotigotine 1	Rotigotine nasal spray	Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)
Placebo 1	Placebo	Placebo nasal spray 1 - 4 puffs
Rotigotine 3	Rotigotine nasal spray	Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)

Primary Outcome Measures

Name	Time	Method
Number of Subjects Who Complete the Trial	15 days

Secondary Outcome Measures

Name	Time	Method
Change From Baseline at 24 Minutes Post-dose in Unified Parkinson Disease Rating Scale (UPDRS) Part III Motor Examination	Baseline, and 24 minutes post-dose	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.
Change From Baseline to 34 Minutes Post-dose in Tapping Rate (Taps/Min)	Baseline and 34 minutes post-dose	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).
"Success Rate" (Percentage of Subjects Achieving "Off" Reversals)	Up to 6 hours post-dose	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.
Time of First "Off" Reversal	Up to 6 hours post-dose	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.