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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00296192
First received: February 22, 2006
Last updated: May 25, 2012
Last verified: February 2011
History of Changes
Results First Received: July 30, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Parkinson's Disease
Interventions: Drug: Rotigotine nasal spray
Other: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants flow shows all subjects randomized. Safety analyses are based on actual treatment received; 4 subjects randomized to placebo were mistreated (1 subject each in the rotigotine 1 puff, rotigotine 2 puffs, rotigotine 3 puffs, and rotigotine 4 puffs treatment arms).

Reporting Groups
  Description
Placebo 1-4 Puffs Placebo nasal spray 1 - 4 puffs
Rotigotine 1 Puff Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)
Rotigotine 2 Puffs Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)
Rotigotine 3 Puffs Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)
Rotigotine 4 Puffs Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)

Participant Flow:   Overall Study
    Placebo 1-4 Puffs     Rotigotine 1 Puff     Rotigotine 2 Puffs     Rotigotine 3 Puffs     Rotigotine 4 Puffs  
STARTED     17     16     16     17     16  
COMPLETED     17     16     16     17     16  
NOT COMPLETED     0     0     0     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Placebo 1-4 Puffs Placebo nasal spray 1 - 4 puffs
Rotigotine 1 Puff Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)
Rotigotine 2 Puffs Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)
Rotigotine 3 Puffs Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)
Rotigotine 4 Puffs Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)
Total Total of all reporting groups

Baseline Measures
    Placebo 1-4 Puffs     Rotigotine 1 Puff     Rotigotine 2 Puffs     Rotigotine 3 Puffs     Rotigotine 4 Puffs     Total  
Number of Participants  
[units: participants]
 		  17     16     16     17     16     82  
Age  
[units: participants]
 		           
<=18 years     0     0     0     0     0     0  
Between 18 and 65 years     9     8     5     9     10     41  
>=65 years     8     8     11     8     6     41  
Age  
[units: years]
Mean ± Standard Deviation 		  63.9  ± 6.94     67.1  ± 7.54     66.8  ± 9.67     63.9  ± 8.28     60.5  ± 8.04     64.4  ± 8.28  
Gender  
[units: participants]
 		           
Female     4     5     4     7     4     24  
Male     13     11     12     10     12     58  
Region of Enrollment  
[units: participants]
 		           
Germany     11     12     12     10     13     58  
Austria     2     2     1     4     1     10  
United Kingdom     1     1     2     0     2     6  
Spain     3     1     1     3     0     8  



  Outcome Measures
  Show All Outcome Measures

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

2.  Secondary:   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 ]
  Show Outcome Measure 2

3.  Secondary:   Change From Baseline to 34 Minutes Post-dose in Tapping Rate (Taps/Min)   [ Time Frame: Baseline and 34 minutes post-dose ]
  Show Outcome Measure 3

4.  Secondary:   "Success Rate" (Percentage of Subjects Achieving "Off" Reversals)   [ Time Frame: Up to 6 hours post-dose ]
  Show Outcome Measure 4

5.  Secondary:   Time of First "Off" Reversal   [ Time Frame: Up to 6 hours post-dose ]
  Show Outcome Measure 5


  Serious Adverse Events
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Time Frame No text entered.
Additional Description Safety analyses are based on actual treatment received; 4 subjects randomized to placebo were mistreated (1 subject each in the rotigotine 1 puff, rotigotine 2 puffs, rotigotine 3 puffs, and rotigotine 4 puffs treatment arms).

Reporting Groups
  Description
Placebo 1-4 Puffs Placebo nasal spray 1 - 4 puffs
Rotigotine 1 Puff Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)
Rotigotine 2 Puffs Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)
Rotigotine 3 Puffs Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)
Rotigotine 4 Puffs Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)

Serious Adverse Events
    Placebo 1-4 Puffs     Rotigotine 1 Puff     Rotigotine 2 Puffs     Rotigotine 3 Puffs     Rotigotine 4 Puffs  
Total, serious adverse events            
# participants affected / at risk     0/13 (0.00%)     0/17 (0.00%)     1/17 (5.88%)     0/18 (0.00%)     1/17 (5.88%)  
Cardiac disorders            
Bradycardia * 1          
# participants affected / at risk     0/13 (0.00%)     0/17 (0.00%)     0/17 (0.00%)     0/18 (0.00%)     1/17 (5.88%)  
# events     0     0     0     0     1  
Psychiatric disorders            
Depression * 1          
# participants affected / at risk     0/13 (0.00%)     0/17 (0.00%)     1/17 (5.88%)     0/18 (0.00%)     0/17 (0.00%)  
# events     0     0     1     0     0  
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA 9.0




  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: UCB Clinical Trial Call Center
Organization: UCB Pharma
phone: +1 877 822 9493


No publications provided


Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00296192     History of Changes
Other Study ID Numbers: SP873, EudraCT: 2005-004290-19
Study First Received: February 22, 2006
Results First Received: July 30, 2009
Last Updated: May 25, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Austria: Agency for Health and Food Safety
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency