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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00296192
Recruitment Status : Completed
First Posted : February 24, 2006
Results First Posted : January 29, 2010
Last Update Posted : October 2, 2014
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Description
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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.


Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: Rotigotine nasal spray Other: Placebo Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2006
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Rotigotine

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Number of Subjects Who Complete the Trial [ Time Frame: 15 days ]

Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. "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.

  4. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00296192


Sponsors and Collaborators
UCB Pharma
Investigators
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Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
More Information
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Additional Information:

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Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00296192    
Other Study ID Numbers: SP0873
EudraCT: 2005-004290-19 ( Other Identifier: EudraCT )
First Posted: February 24, 2006    Key Record Dates
Results First Posted: January 29, 2010
Last Update Posted: October 2, 2014
Last Verified: February 2011
Keywords provided by UCB Pharma:
Rotigotine
Rotigotine nasal spray
Efficacy, safety and tolerability
Parkinson's disease
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
 Neurodegenerative Diseases
Rotigotine
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs