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Parallel-Group Study to Assess the Effect of Rasagiline on Cognition in Patients With Parkinson's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier:
NCT01723228
First received: November 5, 2012
Last updated: February 29, 2016
Last verified: February 2016
Results First Received: January 26, 2016  
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
Drug: 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
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Reporting Groups
  Description
Rasagiline 1.0 mg/Day Rasagiline 1 mg oral tablets once daily for 24 weeks
Placebo Placebo oral tablets once daily for 24 weeks

Participant Flow:   Overall Study
    Rasagiline 1.0 mg/Day     Placebo  
STARTED     86     84  
COMPLETED     78     73  
NOT COMPLETED     8     11  
Adverse Event                 2                 6  
Withdrawal by Subject                 2                 1  
Protocol Violation                 0                 2  
Lost to Follow-up                 2                 1  
Not Specified                 2                 1  



  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
Rasagiline 1.0 mg/Day Rasagiline 1 mg oral tablets once daily for 24 weeks
Placebo Placebo oral tablets once daily for 24 weeks
Total Total of all reporting groups

Baseline Measures
    Rasagiline 1.0 mg/Day     Placebo     Total  
Number of Participants  
[units: participants]
  86     84     170  
Age  
[units: years]
Mean (Standard Deviation)
  66.9  (7.44)     68.1  (8.22)     67.5  (7.84)  
Gender  
[units: participants]
     
Female     21     16     37  
Male     65     68     133  



  Outcome Measures
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1.  Primary:   Mean Change From Baseline to Week 24 in the Scales for Outcomes in Parkinson's Disease-Cognition (SCOPA-COG) Summary Score   [ Time Frame: Baseline to Week 24 (or early discontinuation) ]

2.  Secondary:   Change From Baseline to Week 24 in the Montreal Cognitive Assessment (MoCA) Score   [ Time Frame: Baseline to Week 24 (or early discontinuation) ]

3.  Secondary:   Change From Baseline to Week 24 in the Penn Daily Activities Questionnaire (PDAQ) Score   [ Time Frame: Baseline to Week 24 (or early discontinuation) ]

4.  Secondary:   Alzheimer's Disease Cooperative Study's Clinical Global Impression of Change Modified for Mild Cognitive Impairment (ADCS MCI-CGIC) Score at Week 24   [ Time Frame: Week 24 (or early discontinuation) ]

5.  Secondary:   Change From Baseline to Week 24 in the Unified Parkinson's Disease Rating Scale (UPDRS), Motor Subscale (Part 3), Version 3, Score   [ Time Frame: Baseline to Week 24 (or early discontinuation) ]

6.  Secondary:   Change From Baseline to Week 24 in UPDRS, Activities of Daily Living (ADL) Subscale (Part 2), Version 3, Score   [ Time Frame: Baseline to week 24 (or early discontinuation) ]


  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: Director, Clinical Research
Organization: Teva Branded Pharmaceutical Products, R&D Inc.
phone: 215-591-3000
e-mail: ustevatrials@tevapharm.com


Publications:

Responsible Party: Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier: NCT01723228     History of Changes
Other Study ID Numbers: TVP-1012/PM106
Study First Received: November 5, 2012
Results First Received: January 26, 2016
Last Updated: February 29, 2016
Health Authority: United States: Food and Drug Administration