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

September 24, 2014 updated by: UCB Pharma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

82

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Subjects Who Complete the Trial
Time Frame: 15 days
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
Time Frame: 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.
Baseline, and 24 minutes post-dose
Change From Baseline to 34 Minutes Post-dose in Tapping Rate (Taps/Min)
Time Frame: 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).
Baseline and 34 minutes post-dose
"Success Rate" (Percentage of Subjects Achieving "Off" Reversals)
Time Frame: 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.
Up to 6 hours post-dose
Time of First "Off" Reversal
Time Frame: 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.
Up to 6 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

February 22, 2006

First Submitted That Met QC Criteria

February 22, 2006

First Posted (Estimate)

February 24, 2006

Study Record Updates

Last Update Posted (Estimate)

October 2, 2014

Last Update Submitted That Met QC Criteria

September 24, 2014

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SP0873
  • EudraCT: 2005-004290-19 (Other Identifier: EudraCT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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