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

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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):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Parkinson's Disease
Interventions: Drug: Rotigotine nasal spray
Other: Placebo

  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

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.
No text entered.

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 
Overall Participants Analyzed 
[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

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

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 ]

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

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

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


  Serious Adverse Events


  Other Adverse Events


  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.


  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.


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



Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00296192     History of Changes
Other Study ID Numbers: SP0873
EudraCT: 2005-004290-19 ( Other Identifier: EudraCT )
First Submitted: February 22, 2006
First Posted: February 24, 2006
Results First Submitted: July 30, 2009
Results First Posted: January 29, 2010
Last Update Posted: October 2, 2014