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)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00977665 |
Recruitment Status :
Completed
First Posted : September 16, 2009
Results First Posted : February 26, 2015
Last Update Posted : February 26, 2015
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Sponsor:
Teva Pharmaceutical Industries
Collaborator:
H. Lundbeck A/S
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Multiple System Atrophy |
Interventions |
Drug: rasagiline mesylate Drug: placebo |
Enrollment | 174 |
Participant Flow
Recruitment Details | |
Pre-assignment Details | Eligible participants were randomized in a 1:1 ratio to either active treatment or placebo. |
Arm/Group Title | Rasagiline Mesylate | Placebo |
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rasagiline tablet, 1 mg/day for up to 48 weeks. | placebo tablet for up to 48 weeks. |
Period Title: Overall Study | ||
Started | 84 | 90 |
Completed | 63 | 75 |
Not Completed | 21 | 15 |
Reason Not Completed | ||
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
Arm/Group Title | Rasagiline Mesylate | Placebo | Total | |
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rasagiline tablet, 1 mg/day for up to 48 weeks. | placebo tablet for up to 48 weeks. | Total of all reporting groups | |
Overall Number of Baseline Participants | 84 | 90 | 174 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 84 participants | 90 participants | 174 participants | |
64.9 (8.5) | 65.1 (8.6) | 65.0 (8.5) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 84 participants | 90 participants | 174 participants | |
Female |
35 41.7%
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39 43.3%
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74 42.5%
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Male |
49 58.3%
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51 56.7%
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100 57.5%
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Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 84 participants | 90 participants | 174 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
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 84 participants | 90 participants | 174 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
Mean (Standard Deviation) Unit of measure: Kg |
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Number Analyzed | 84 participants | 90 participants | 174 participants | |
76.9 (15.9) | 76.8 (15.5) | 76.9 (15.6) | ||
Height
Mean (Standard Deviation) Unit of measure: Cm |
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Number Analyzed | 84 participants | 90 participants | 174 participants | |
168.0 (10.2) | 169.0 (8.9) | 168.5 (9.6) | ||
Body Mass Index
Mean (Standard Deviation) Unit of measure: Kg/m^2 |
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Number Analyzed | 84 participants | 90 participants | 174 participants | |
27.2 (4.4) | 26.8 (4.4) | 27.0 (4.4) | ||
Multiple System Atrophy of the Parkinsonian Subtype (MSA-P)
[1] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 84 participants | 90 participants | 174 participants |
Possible MSA-P | 38 | 55 | 93 | |
Probable MSA-P | 46 | 35 | 81 | |
[1]
Measure Description:
Possible or Probable MSA of the parkinsonian subtype (MSA-P) is according to The Gilman Criteria (2008).
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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.
Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
Results Point of Contact
Name/Title: | Director, Clinical Research |
Organization: | Teva Branded Pharmaceutical Products, R&D Inc. |
Phone: | 215-591-3000 |
EMail: | ustevatrials@tevapharm.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Teva Pharmaceutical Industries |
ClinicalTrials.gov Identifier: | NCT00977665 |
Other Study ID Numbers: |
MSA-RAS-202 2009-014644-11 ( EudraCT Number ) |
First Submitted: | September 15, 2009 |
First Posted: | September 16, 2009 |
Results First Submitted: | February 10, 2015 |
Results First Posted: | February 26, 2015 |
Last Update Posted: | February 26, 2015 |