A Randomized Placebo Controlled Study to Show That Rasagiline May Slow Disease Progression for Parkinson's Disease (ADAGIO)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00256204
First received: November 16, 2005
Last updated: January 10, 2012
Last verified: January 2012
Results First Received: March 8, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Parkinson's Disease
Interventions: Drug: Rasagiline Mesylate
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
No text entered.

Reporting Groups
  Description
1mg Delayed Start 1mg Rasagiline tablet QD 36 week delayed start active treatment arms (36 weeks placebo followed by 36 weeks Rasagiline)
1mg Early Start 1mg Rasagiline tablet QD early start active treatment arm (72 weeks active)
2mg Delayed Start 2mg Rasagiline tablet QD 36 week delayed start active treatment arms (36 weeks placebo followed by 36 weeks Rasagiline)
2mg Early Start 2mg Rasagiline tablet QD early start active treatment arm (72 weeks active)

Participant Flow:   Overall Study
    1mg Delayed Start     1mg Early Start     2mg Delayed Start     2mg Early Start  
STARTED     298     288     295     293  
COMPLETED     231     238     241     244  
NOT COMPLETED     67     50     54     49  
Adverse Event                 10                 14                 16                 14  
Death                 0                 1                 0                 0  
Lost to Follow-up                 1                 1                 1                 2  
Protocol Violation                 1                 0                 2                 1  
Physician Decision                 0                 0                 1                 2  
Withdrawal by Subject                 17                 6                 7                 5  
Need for additional prohibited treatment                 38                 28                 27                 25  



  Baseline Characteristics
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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.
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Reporting Groups
  Description
1mg Delayed Start 1mg Rasagiline tablet QD 36 week delayed start active treatment arms (36 weeks placebo followed by 36 weeks Rasagiline)
1mg Early Start 1mg Rasagiline tablet QD early start active treatment arm (72 weeks active)
2mg Early Start 2mg Rasagiline tablet QD early start active treatment arm (72 weeks active)
2mg Delayed Start 2mg Rasagiline tablet QD 36 week delayed start active treatment arms (36 weeks placebo followed by 36 weeks Rasagiline)
Total Total of all reporting groups

Baseline Measures
    1mg Delayed Start     1mg Early Start     2mg Early Start     2mg Delayed Start     Total  
Number of Participants  
[units: participants]
  298     288     293     295     1174  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     175     163     169     173     680  
>=65 years     123     125     124     122     494  
Age  
[units: years]
Mean ± Standard Deviation
  61.9  ± 9.6     62.4  ± 9.7     62.3  ± 9.6     62.4  ± 9.7     62.2  ± 9.6  
Gender  
[units: participants]
         
Female     113     113     118     113     457  
Male     185     175     175     182     717  
Region of Enrollment  
[units: participants]
         
United States     102     91     94     98     385  
Portugal     4     4     4     4     16  
Spain     12     12     12     12     48  
Austria     2     2     2     2     8  
Israel     22     23     21     21     87  
United Kingdom     7     7     9     8     31  
Italy     24     25     28     25     102  
France     11     11     12     14     48  
Hungary     8     8     6     7     29  
Canada     28     27     29     25     109  
Argentina     17     17     16     18     68  
Romania     25     24     25     24     98  
Germany     27     28     26     28     109  
Netherlands     9     9     9     9     36  



  Outcome Measures
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1.  Primary:   Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline   [ Time Frame: 12w, 24w, 36w, 42w, 48w, 54w, 60w, 66w, 72w ]

2.  Secondary:   Change in Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline to Last Observed Value in the Placebo Phase   [ Time Frame: 36 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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.


Results Point of Contact:  
Name/Title: Dennis Ahern, MS, Director
Organization: Teva Branded Pharmaceutical Products R&D
phone: 215-293-6339
e-mail: dennis.ahern@tevausa.com


No publications provided by Teva Pharmaceutical Industries

Publications automatically indexed to this study:

Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT00256204     History of Changes
Other Study ID Numbers: TVP-1012/500 (ADAGIO)
Study First Received: November 16, 2005
Results First Received: March 8, 2010
Last Updated: January 10, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada