Text Size

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
  Hide Participant Flow

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
  Hide Baseline Characteristics

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 ]
  Hide Outcome Measure 3

Measure Type Secondary
Measure Title Change From Baseline to 34 Minutes Post-dose in Tapping Rate (Taps/Min)
Measure Description 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).
Time Frame Baseline and 34 minutes post-dose  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set: Subjects receiving at least one delivery of trial medication and with at least one post-baseline efficacy measurement. Missing values at 34 minutes post-dose timepoint were not imputed; number of observations at 34 minutes post-dose timepoint may be less than that for baseline timepoint.

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)

Measured Values
    Placebo 1-4 Puffs     Rotigotine 1 Puff     Rotigotine 2 Puffs     Rotigotine 3 Puffs     Rotigotine 4 Puffs  
Number of Participants Analyzed  
[units: participants]
 		  17     16     16     17     16  
Change From Baseline to 34 Minutes Post-dose in Tapping Rate (Taps/Min)  
[units: taps per minute]
Mean ± Standard Deviation 		         
Baseline     112.7  ± 47.08     109.8  ± 28.94     127.2  ± 44.33     115.9  ± 41.05     118.3  ± 40.41  
34 minutes post-dose     141.2  ± 50.92     131.0  ± 30.01     138.7  ± 44.42     142.9  ± 51.20     144.4  ± 57.64  
Change from baseline to 34 minutes post-dose     28.5  ± 27.83     21.2  ± 26.69     11.5  ± 11.27     27.1  ± 25.25     22.9  ± 27.75  


Statistical Analysis 1 for Change From Baseline to 34 Minutes Post-dose in Tapping Rate (Taps/Min)
Groups [1] Placebo 1-4 Puffs vs. Rotigotine 1 Puff
Mean Difference (Net) [2] -8.6
Standard Error of the mean ± 8.58
95% Confidence Interval ( -25.7 to 8.5 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Analysis of covariance modeling change from baseline to 34 minutes post-dose in tapping rate, controlling for treatment group and baseline value.
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change From Baseline to 34 Minutes Post-dose in Tapping Rate (Taps/Min)
Groups [1] Placebo 1-4 Puffs vs. Rotigotine 2 Puffs
Mean Difference (Net) [2] -16.8
Standard Error of the mean ± 8.63
95% Confidence Interval ( -34.0 to 0.4 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Analysis of covariance modeling change from baseline to 34 minutes post-dose in tapping rate, controlling for treatment group and baseline value.
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Change From Baseline to 34 Minutes Post-dose in Tapping Rate (Taps/Min)
Groups [1] Placebo 1-4 Puffs vs. Rotigotine 3 Puffs
Mean Difference (Net) [2] -1.4
Standard Error of the mean ± 8.45
95% Confidence Interval ( -18.2 to 15.4 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Analysis of covariance modeling change from baseline to 34 minutes post-dose in tapping rate, controlling for treatment group and baseline value.
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 4 for Change From Baseline to 34 Minutes Post-dose in Tapping Rate (Taps/Min)
Groups [1] Placebo 1-4 Puffs vs. Rotigotine 4 Puffs
Mean Difference (Net) [2] -5.5
Standard Error of the mean ± 8.90
95% Confidence Interval ( -23.3 to 12.2 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Analysis of covariance modeling change from baseline to 34 minutes post-dose in tapping rate, controlling for treatment group and baseline value.
[2] Other relevant estimation information:
  No text entered.



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
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

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