Clinical Trial to Assess Efficacy, Safety, and Tolerability of Rasagiline Mesylate 1 mg in Patients With Multiple System Atrophy of the Parkinsonian Subtype (MSA-P)

This study has been completed.
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00977665
First received: September 15, 2009
Last updated: February 10, 2015
Last verified: February 2015
Results First Received: February 10, 2015  
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: Multiple System Atrophy
Interventions: Drug: rasagiline mesylate
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
Eligible participants were randomized in a 1:1 ratio to either active treatment or placebo.

Reporting Groups
  Description
Rasagiline Mesylate rasagiline tablet, 1 mg/day for up to 48 weeks.
Placebo placebo tablet for up to 48 weeks.

Participant Flow:   Overall Study
    Rasagiline Mesylate     Placebo  
STARTED     84     90  
COMPLETED     63     75  
NOT COMPLETED     21     15  
Withdrawal by Subject                 1                 3  
Physician Decision                 2                 1  
Sponsor requested withdrawal                 0                 1  
Lost to Follow-up                 1                 0  
Death                 3                 2  
Adverse Event                 14                 7  
Treatment failure                 0                 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.
No text entered.

Reporting Groups
  Description
Rasagiline Mesylate rasagiline tablet, 1 mg/day for up to 48 weeks.
Placebo placebo tablet for up to 48 weeks.
Total Total of all reporting groups

Baseline Measures
    Rasagiline Mesylate     Placebo     Total  
Number of Participants  
[units: participants]
  84     90     174  
Age  
[units: years]
Mean (Standard Deviation)
  64.9  (8.5)     65.1  (8.6)     65.0  (8.5)  
Gender  
[units: participants]
     
Female     35     39     74  
Male     49     51     100  
Race/Ethnicity, Customized  
[units: participants]
     
Asian/Oriental     0     2     2  
Black of African Heritage     2     0     2  
Black or African American     0     2     2  
Caucasian     81     85     166  
Unknown     1     1     2  
Region of Enrollment  
[units: participants]
     
Portugal     2     3     5  
United States     16     16     32  
France     9     8     17  
Hungary     11     10     21  
Canada     10     10     20  
Spain     4     3     7  
Austria     3     4     7  
Israel     9     12     21  
Germany     7     12     19  
Netherlands     3     2     5  
Italy     8     8     16  
United Kingdom     2     2     4  
Weight  
[units: kg]
Mean (Standard Deviation)
  76.9  (15.9)     76.8  (15.5)     76.9  (15.6)  
Height  
[units: cm]
Mean (Standard Deviation)
  168.0  (10.2)     169.0  (8.9)     168.5  (9.6)  
Body Mass Index  
[units: kg/m^2]
Mean (Standard Deviation)
  27.2  (4.4)     26.8  (4.4)     27.0  (4.4)  
Multiple System Atrophy of the Parkinsonian Subtype (MSA-P) [1]
[units: participants]
     
Possible MSA-P     38     55     93  
Probable MSA-P     46     35     81  
[1]

Possible or Probable MSA of the parkinsonian subtype (MSA-P) is according to The Gilman Criteria (2008).

  • Possible MSA requires a sporadic, progressive adult-onset disease including parkinsonism and at least one feature suggesting autonomic dysfunction plus one other feature that may be a clinical or a neuroimaging abnormality.
  • Probable MSA requires a sporadic, progressive adult-onset disorder including rigorously defined autonomic failure and poorly levodopa-responsive parkinsonism.



  Outcome Measures
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1.  Primary:   Change From Baseline to Week 48/Termination Visit in the Total Unified Multiple System Atrophy Rating Scale (UMSARS Part I and II)   [ Time Frame: Day 0 (baseline), Week 48 ]

2.  Secondary:   Clinical Global Impression Improvement (CGI-I) at Week 48/Termination Visit   [ Time Frame: Week 48 ]

3.  Secondary:   Change From Baseline to Week 24 in Total Unified Multiple System Atrophy Rating Scale (UMSARS) Score   [ Time Frame: Day 0 (baseline), Week 24 ]

4.  Secondary:   Percentage of Participants Who Achieved a Score of >=3 on the Unified Multiple System Atrophy Rating Scale (UMSARS) Question #7 Regarding Ambulation   [ Time Frame: up to week 48 ]

5.  Secondary:   Mean Score of the Composite Autonomic Symptom Scale Select (COMPASS_Select Change) at Week 48/Termination Visit   [ Time Frame: 48 weeks ]

6.  Secondary:   Change From Baseline to Week 48/Termination Visit in the Multiple System Atrophy (MSA) Health-related Quality of Life (QoL) Scale   [ Time Frame: Day 0 (baseline), Week 48 ]

7.  Secondary:   Rate of Progression in Total Unified Multiple System Atrophy Rating Scale (UMSARS) Score From Baseline to Weeks 12-48   [ Time Frame: Day 0 (baseline), Weeks 12-48 ]

8.  Secondary:   Change From Baseline to Week 48 or Termination in UMSARS Subscores for Parts I, II and IV   [ Time Frame: Day 0 (baseline), Week 48 or termination visit ]

9.  Secondary:   Change From Baseline to Week 12 in Total UMSARS Score for Symptomatic Effect   [ Time Frame: Day 0 (baseline), Week 12 ]

10.  Secondary:   Estimates for Time to Change in Anti-Parkinsonian or Anti-Orthostatis Hypotension Medications   [ Time Frame: Day 0 (baseline) to Week 48 or termination visit ]

11.  Secondary:   Change From Baseline to Week 48 or Termination in the Montreal Cognitive Assessment Scale (MoCA) Scale   [ Time Frame: Day 0 (baseline), Week 48 or termination visit ]

12.  Secondary:   Percentage of Participants Who Achieved a Score of >=3 on the Unified Multiple System Atrophy Rating Scale (UMSARS) Question #1 (Speech Impairment), Question #2 (Swallowing Impairment) and Question #8 (Falling)   [ Time Frame: up to week 48 ]

13.  Secondary:   Change From Baseline to Week 48 or Termination in the Beck Depression Inventory Scale (BDI-II)   [ Time Frame: Day 0 (baseline), Week 48 or termination visit ]

14.  Secondary:   Total Number of Falls During the Study   [ Time Frame: Day 1 up to week 48 ]


  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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT00977665     History of Changes
Other Study ID Numbers: MSA-RAS-202
2009-014644-11 ( EudraCT Number )
Study First Received: September 15, 2009
Results First Received: February 10, 2015
Last Updated: February 10, 2015
Health Authority: United States: Food and Drug Administration