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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-014644-11 | EudraCT Number |
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| Name | Class |
|---|---|
| H. Lundbeck A/S | INDUSTRY |
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To test the clinical effect of rasagiline on subjects with MSA of the parkinsonian subtype.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rasagiline mesylate | Experimental | rasagiline tablet, 1 mg/day for up to 48 weeks. |
|
| placebo | Placebo Comparator | placebo tablet for up to 48 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rasagiline mesylate | Drug | rasagiline 1 mg tablet/day for 48 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 48/Termination Visit in the Total Unified Multiple System Atrophy Rating Scale (UMSARS Part I and II) | This outcome represents the sum of 2 UMSARS sub-scales: Part I: Historical Review that includes 12 items and Part II: Motor Examination that includes 14 items. All items range from 0 to 4. Each subscale score is the sum of its items and the total UMSARS score is the sum of all 26 items. Hence the total UMSARS score can range from 0 to 104, with 0 meaning no impairment and 104 indicating severe impairment. Negative change from baseline scores indicate improvement. In the case that 6 items or more (out of 26) were missing at a certain visit, the UMSARS score for that visit was assigned a missing value. | Day 0 (baseline), Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression Improvement (CGI-I) at Week 48/Termination Visit | Outcome measures the investigator's clinical impression of the participants' improvement at Week 48 as compared to Week 12. CGI scale range from 1-7, with 1=very much improved, 4= no change, and 7=very much worse. In order to maintain the overall (hypotheses about primary and key secondary endpoints) type I error at the 0.05 level an hierarchy will be employed as follows: If the primary endpoint will be found to be significant at a significance level of 0.05 then the first key secondary endpoint will be tested, if this endpoint will be found to be significant in a significance level of 0.05 then the second key secondary endpoint will be tested and so on. The 'key' secondary endpoints are outcomes 2-6. |
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Inclusion Criteria:
Exclusion Criteria:
Subjects receiving treatment with midodrine or other sympathomimetics within 4 weeks prior to baseline visit.
Subjects with severe orthostatic symptoms as assessed by a score of ≥ 3 on Unified Multiple System Atrophy Rating Scale (UMSARS) question 9.
Subjects who meet any of the following criteria which tend to suggest advanced disease:
Subjects taking disallowed medications according to the locally approved Azilect® label.
Subjects taking monoamine oxidase (MAO) inhibitors within 3 months prior to baseline visit.
Subjects with hypertension whose blood pressure, in the investigator's opinion, is not well controlled.
Subjects who, based on the investigator's judgment, have a clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation. Subjects with moderate or severe hepatic impairment.
Subjects who have taken any investigational products within 60 days prior to baseline.
Women of child-bearing potential who do not practice an acceptable method of birth control [acceptable methods of birth control in this study are: surgical sterilization, intrauterine devices, oral contraceptive, contraceptive patch, long-acting injectable contraceptive, partner's vasectomy, a double-protection method (condom or diaphragm with spermicide)].
Pregnant or nursing women.
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| Name | Affiliation | Role |
|---|---|---|
| Werner Poewe, Prof | Innsbruck Medical University, Innsbruck, Austria | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teva Investigational Site 1004 | Irvine | California | United States | |||
| Teva Investigational Site 1014 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25498732 | Derived | Poewe W, Seppi K, Fitzer-Attas CJ, Wenning GK, Gilman S, Low PA, Giladi N, Barone P, Sampaio C, Eyal E, Rascol O; Rasagiline-for-MSA investigators. Efficacy of rasagiline in patients with the parkinsonian variant of multiple system atrophy: a randomised, placebo-controlled trial. Lancet Neurol. 2015 Feb;14(2):145-52. doi: 10.1016/S1474-4422(14)70288-1. Epub 2014 Dec 8. |
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Eligible participants were randomized in a 1:1 ratio to either active treatment or placebo.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rasagiline Mesylate | rasagiline tablet, 1 mg/day for up to 48 weeks. |
| FG001 | Placebo | placebo tablet for up to 48 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| placebo | Drug | placebo tablet for 48 weeks |
|
| Week 48 |
| Change From Baseline to Week 24 in Total Unified Multiple System Atrophy Rating Scale (UMSARS) Score | The UMSARS is composed of 2 sub-scales: Part I: Historical Review that includes 12 items and Part II: Motor Examination that includes 14 items. All items range from 0 to 4. Each subscale score is the sum of its items and the total UMSARS score is the sum of all 26 items. Hence the total UMSARS score can range from 0 to 104, with 0 meaning no impairment and 104 indicating severe impairment. Negative change from baseline scores indicate improvement. In the case that 6 items or more (out of 26) were missing at a certain visit, the UMSARS score for that visit was assigned a missing value. | Day 0 (baseline), Week 24 |
| Percentage of Participants Who Achieved a Score of >=3 on the Unified Multiple System Atrophy Rating Scale (UMSARS) Question #7 Regarding Ambulation | UMSARS' Question #7 concerns the participant's ability to walk, rated on a scale of 0=normal to 4=cannot walk at all even with assistance. This endpoint counts participants rated a 3 or worse. Rating 3 = Severely impaired; assistance and/or walking aid needed occasionally. | up to week 48 |
| Mean Score of the Composite Autonomic Symptom Scale Select (COMPASS_Select Change) at Week 48/Termination Visit | COMPASS_Select change is comprised of 5 of the 11 domains in the COMPASS scale: Orthostatic Intolerance, Bladder Disorder, Sweating, Vasomotor, and Sleep Disorder COMPASS_Select change has a range of -150 to 150, with -150 indicating symptoms are much better and 150 indicating symptoms are much worse. | 48 weeks |
| Change From Baseline to Week 48/Termination Visit in the Multiple System Atrophy (MSA) Health-related Quality of Life (QoL) Scale | The Multiple System Atrophy Quality of Life questionnaire (MSA-QoL) is a self-reported questionnaire focusing on MSA-specific symptoms and has a scale ranging from 0 - 160, with 0= 'no problem' and 160= "extreme problem". | Day 0 (baseline), Week 48 |
| Rate of Progression in Total Unified Multiple System Atrophy Rating Scale (UMSARS) Score From Baseline to Weeks 12-48 | The UMSARS is composed of 2 sub-scales: Part I: Historical Review that includes 12 items and Part II: Motor Examination that includes 14 items. All items range from 0 to 4. Each subscale score is the sum of its items and the total UMSARS score is the sum of all 26 items. Hence the total UMSARS score can range from 0 to 104, with 0 meaning no impairment and 104 indicating severe impairment. The rate of progression of atrophy is represented by the slope of change from baseline scores for visits between Weeks 12 and 48. | Day 0 (baseline), Weeks 12-48 |
| Change From Baseline to Week 48 or Termination in UMSARS Subscores for Parts I, II and IV | UMSARS Part I is an historical review and scores symptoms of neurological and autonomic dysfunction with 12 items rated on a scale of 0 (normal) to 4 (extreme dysfunction). The full scale for Part 1 is therefore 0 (normal) to 48 (extreme dysfunction). Part II is a motor examination and has 14 items also rated on a scale of 0 to 4 for a full scale of 0 (normal) to 56 (extreme dysfunction). Part IV is a global disability scale with rates the extent of disease from 1 (normal) to 5 (severe disease). | Day 0 (baseline), Week 48 or termination visit |
| Change From Baseline to Week 12 in Total UMSARS Score for Symptomatic Effect | This outcome represents the sum of 2 UMSARS sub-scales: Part I: Historical Review that includes 12 items and Part II: Motor Examination that includes 14 items. All items range from 0 to 4. Each subscale score is the sum of its items and the total UMSARS score is the sum of all 26 items. Hence the total UMSARS score can range from 0 to 104, with 0 meaning no impairment and 104 indicating severe impairment. Negative change from baseline scores indicate improvement. | Day 0 (baseline), Week 12 |
| Estimates for Time to Change in Anti-Parkinsonian or Anti-Orthostatis Hypotension Medications | Change in anti-parkinsonian or anti-orthostatic hypotension medication is defined by at least one of the following events:
The event of interest, determined on a by patient basis, therefore, is the earliest event of the two events defined above. Otherwise, patient is right censored according to his/her study termination date. Since less than 25% of participants had an event, median estimatation for time to change in medications is not possible. | Day 0 (baseline) to Week 48 or termination visit |
| Change From Baseline to Week 48 or Termination in the Montreal Cognitive Assessment Scale (MoCA) Scale | MoCA is a cognitive screening test which helps health professionals identify mild cognitive impairment. The total scale is 0 (significant cognitive impairment) to 30 (no impairment detected). Scores >=26 are considered normal. Positive change from baseline scores indicate improvement in cognition. | Day 0 (baseline), Week 48 or termination visit |
| 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) | UMSARS' questions are rated on a scale of 0=normal to 4=extreme impairment. This endpoint reports the percentage of participants rated a 3 or worse. Rating 3 = Severely impaired speech (Question #1), swallowing (Question #2) or falling more frequently than once per week (Question #8). | up to week 48 |
| Change From Baseline to Week 48 or Termination in the Beck Depression Inventory Scale (BDI-II) | The Beck Depression Inventory (BDI-II), is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression. Participants are asked to pick the answer for each question that best describes the way they have been feeling in the past two weeks, including the day participants complete the questionnaire. Each question is rated on a scale of 0-3, with 0 meaning the participant does not feel the emotion described in the question, and 3 meaning the participant has extremely strong feelings. Total scale is 0 (no evidence of depression) to 63 (extreme depression). Negative change from baseline scores indicate improvement in level of depression. | Day 0 (baseline), Week 48 or termination visit |
| Total Number of Falls During the Study | Participants recorded each time they fell during the study in a diary. | Day 1 up to week 48 |
| La Jolla |
| California |
| United States |
| Teva Investigational Site 1006 | Sunnyvale | California | United States |
| Teva Investigational Site 1010 | Washington D.C. | District of Columbia | United States |
| Teva Investigational Site 1061 | Boca Raton | Florida | United States |
| Teva Investigational Site 1012 | Tampa | Florida | United States |
| Teva Investigational Site 1009 | Worcester | Massachusetts | United States |
| Teva Investigational Site 1003 | Ann Arbor | Michigan | United States |
| Teva Investigational Site 1007 | Rochester | Minnesota | United States |
| Teva Investigational Site 1011 | St Louis | Missouri | United States |
| Teva Investigational Site 1008 | Rochester | New York | United States |
| Teva Investigational Site 1001 | Cleveland | Ohio | United States |
| Teva Investigational Site 1002 | Philadelphia | Pennsylvania | United States |
| Teva Investigational Site 1013 | Nashville | Tennessee | United States |
| Teva Investigational Site 1005 | Houston | Texas | United States |
| Teva Investigational Site 3305 | Graz | Austria |
| Teva Investigational Site 3304 | Innsbruck | Austria |
| Teva Investigational Site 1109 | Ottawa | Ontario | Canada |
| Teva Investigational Site 1111 | Greenfield Park | Quebec | Canada |
| Teva Investigational Site 1108 | Montreal | Quebec | Canada |
| Teva Investigational Site 1110 | Québec | Quebec | Canada |
| Teva Investigational Site 3503 | Lille | France |
| Teva Investigational Site 3502 | Pessac | France |
| Teva Investigational Site 3206 | Dresden | Germany |
| Teva Investigational Site 3203 | Kiel | Germany |
| Teva Investigational Site 3201 | Marburg | Germany |
| Teva Investigational Site 3205 | München | Germany |
| Teva Investigational Site 3204 | Tübingen | Germany |
| Teva Investigational Site 3202 | Ulm | Germany |
| Teva Investigational Site 5101 | Budapest | Hungary |
| Teva Investigational Site 5102 | Debrecen | Hungary |
| Teva Investigational Site 5103 | Miskolc | Hungary |
| Teva Investigational Site 8002 | Ramat Gan | IL | Israel |
| Teva Investigational Site 8004 | Haifa | Israel |
| Teva Investigational Site 8003 | Tel Aviv | Israel |
| Teva Investigational Site 3006 | Bologna | Italy |
| Teva Investigational Site 3004 | Roma | Italy |
| Teva Investigational Site 3005 | Venezia - Lido | Italy |
| Teva Investigational Site 3801 | Amersfoort | Netherlands |
| Teva Investigational Site 3802 | Sittard-Geleen | Netherlands |
| Teva Investigational Site 3603 | Lisbon | Portugal |
| Teva Investigational Site 3101 | Barcelona | Spain |
| Teva Investigational Site 3102 | Barcelona | Spain |
| Teva Investigational Site 3103 | Seville | Spain |
| Teva Investigational Site 3403 | Cardiff, Wales | United Kingdom |
| Teva Investigational Site 3401 | London | United Kingdom |
| Teva Investigational Site 3402 | Newcastle upon Tyne | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Rasagiline Mesylate | rasagiline tablet, 1 mg/day for up to 48 weeks. |
| BG001 | Placebo | placebo tablet for up to 48 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| |||||||||||||||
| Height | Mean | Standard Deviation | cm |
| |||||||||||||||
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| Multiple System Atrophy of the Parkinsonian Subtype (MSA-P) | Possible or Probable MSA of the parkinsonian subtype (MSA-P) is according to The Gilman Criteria (2008).
| Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline to Week 48/Termination Visit in the Total Unified Multiple System Atrophy Rating Scale (UMSARS Part I and II) | This outcome represents the sum of 2 UMSARS sub-scales: Part I: Historical Review that includes 12 items and Part II: Motor Examination that includes 14 items. All items range from 0 to 4. Each subscale score is the sum of its items and the total UMSARS score is the sum of all 26 items. Hence the total UMSARS score can range from 0 to 104, with 0 meaning no impairment and 104 indicating severe impairment. Negative change from baseline scores indicate improvement. In the case that 6 items or more (out of 26) were missing at a certain visit, the UMSARS score for that visit was assigned a missing value. | Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment were included in the principal efficacy analysis, according to the treatment group to which they were originally assigned. | Posted | Least Squares Mean | Standard Error | units on a scale | Day 0 (baseline), Week 48 |
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| Secondary | Clinical Global Impression Improvement (CGI-I) at Week 48/Termination Visit | Outcome measures the investigator's clinical impression of the participants' improvement at Week 48 as compared to Week 12. CGI scale range from 1-7, with 1=very much improved, 4= no change, and 7=very much worse. In order to maintain the overall (hypotheses about primary and key secondary endpoints) type I error at the 0.05 level an hierarchy will be employed as follows: If the primary endpoint will be found to be significant at a significance level of 0.05 then the first key secondary endpoint will be tested, if this endpoint will be found to be significant in a significance level of 0.05 then the second key secondary endpoint will be tested and so on. The 'key' secondary endpoints are outcomes 2-6. | Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment. | Posted | Least Squares Mean | Standard Error | units on a scale | Week 48 |
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| Secondary | Change From Baseline to Week 24 in Total Unified Multiple System Atrophy Rating Scale (UMSARS) Score | The UMSARS is composed of 2 sub-scales: Part I: Historical Review that includes 12 items and Part II: Motor Examination that includes 14 items. All items range from 0 to 4. Each subscale score is the sum of its items and the total UMSARS score is the sum of all 26 items. Hence the total UMSARS score can range from 0 to 104, with 0 meaning no impairment and 104 indicating severe impairment. Negative change from baseline scores indicate improvement. In the case that 6 items or more (out of 26) were missing at a certain visit, the UMSARS score for that visit was assigned a missing value. | Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment. | Posted | Least Squares Mean | Standard Error | units on a scale | Day 0 (baseline), Week 24 |
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| Secondary | Percentage of Participants Who Achieved a Score of >=3 on the Unified Multiple System Atrophy Rating Scale (UMSARS) Question #7 Regarding Ambulation | UMSARS' Question #7 concerns the participant's ability to walk, rated on a scale of 0=normal to 4=cannot walk at all even with assistance. This endpoint counts participants rated a 3 or worse. Rating 3 = Severely impaired; assistance and/or walking aid needed occasionally. | Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment. | Posted | Number | percentage of participants | up to week 48 |
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| Secondary | Mean Score of the Composite Autonomic Symptom Scale Select (COMPASS_Select Change) at Week 48/Termination Visit | COMPASS_Select change is comprised of 5 of the 11 domains in the COMPASS scale: Orthostatic Intolerance, Bladder Disorder, Sweating, Vasomotor, and Sleep Disorder COMPASS_Select change has a range of -150 to 150, with -150 indicating symptoms are much better and 150 indicating symptoms are much worse. | Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment. | Posted | Least Squares Mean | Standard Error | units on a scale | 48 weeks |
|
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| Secondary | Change From Baseline to Week 48/Termination Visit in the Multiple System Atrophy (MSA) Health-related Quality of Life (QoL) Scale | The Multiple System Atrophy Quality of Life questionnaire (MSA-QoL) is a self-reported questionnaire focusing on MSA-specific symptoms and has a scale ranging from 0 - 160, with 0= 'no problem' and 160= "extreme problem". | Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment. | Posted | Least Squares Mean | Standard Error | units on a scale | Day 0 (baseline), Week 48 |
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| Secondary | Rate of Progression in Total Unified Multiple System Atrophy Rating Scale (UMSARS) Score From Baseline to Weeks 12-48 | The UMSARS is composed of 2 sub-scales: Part I: Historical Review that includes 12 items and Part II: Motor Examination that includes 14 items. All items range from 0 to 4. Each subscale score is the sum of its items and the total UMSARS score is the sum of all 26 items. Hence the total UMSARS score can range from 0 to 104, with 0 meaning no impairment and 104 indicating severe impairment. The rate of progression of atrophy is represented by the slope of change from baseline scores for visits between Weeks 12 and 48. | Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment. | Posted | Mean | Standard Error | units on a scale/week | Day 0 (baseline), Weeks 12-48 |
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| Secondary | Change From Baseline to Week 48 or Termination in UMSARS Subscores for Parts I, II and IV | UMSARS Part I is an historical review and scores symptoms of neurological and autonomic dysfunction with 12 items rated on a scale of 0 (normal) to 4 (extreme dysfunction). The full scale for Part 1 is therefore 0 (normal) to 48 (extreme dysfunction). Part II is a motor examination and has 14 items also rated on a scale of 0 to 4 for a full scale of 0 (normal) to 56 (extreme dysfunction). Part IV is a global disability scale with rates the extent of disease from 1 (normal) to 5 (severe disease). | Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment. | Posted | Least Squares Mean | Standard Error | units on a scale | Day 0 (baseline), Week 48 or termination visit |
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| Secondary | Change From Baseline to Week 12 in Total UMSARS Score for Symptomatic Effect | This outcome represents the sum of 2 UMSARS sub-scales: Part I: Historical Review that includes 12 items and Part II: Motor Examination that includes 14 items. All items range from 0 to 4. Each subscale score is the sum of its items and the total UMSARS score is the sum of all 26 items. Hence the total UMSARS score can range from 0 to 104, with 0 meaning no impairment and 104 indicating severe impairment. Negative change from baseline scores indicate improvement. | Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment. | Posted | Mean | Standard Deviation | units on a scale | Day 0 (baseline), Week 12 |
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| Secondary | Estimates for Time to Change in Anti-Parkinsonian or Anti-Orthostatis Hypotension Medications | Change in anti-parkinsonian or anti-orthostatic hypotension medication is defined by at least one of the following events:
The event of interest, determined on a by patient basis, therefore, is the earliest event of the two events defined above. Otherwise, patient is right censored according to his/her study termination date. Since less than 25% of participants had an event, median estimatation for time to change in medications is not possible. | Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment. | Posted | Median | 95% Confidence Interval | days | Day 0 (baseline) to Week 48 or termination visit |
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| Secondary | Change From Baseline to Week 48 or Termination in the Montreal Cognitive Assessment Scale (MoCA) Scale | MoCA is a cognitive screening test which helps health professionals identify mild cognitive impairment. The total scale is 0 (significant cognitive impairment) to 30 (no impairment detected). Scores >=26 are considered normal. Positive change from baseline scores indicate improvement in cognition. | Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment. | Posted | Least Squares Mean | Standard Error | units on a scale | Day 0 (baseline), Week 48 or termination visit |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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) | UMSARS' questions are rated on a scale of 0=normal to 4=extreme impairment. This endpoint reports the percentage of participants rated a 3 or worse. Rating 3 = Severely impaired speech (Question #1), swallowing (Question #2) or falling more frequently than once per week (Question #8). | Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment. | Posted | Number | percentage of participants | up to week 48 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 48 or Termination in the Beck Depression Inventory Scale (BDI-II) | The Beck Depression Inventory (BDI-II), is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression. Participants are asked to pick the answer for each question that best describes the way they have been feeling in the past two weeks, including the day participants complete the questionnaire. Each question is rated on a scale of 0-3, with 0 meaning the participant does not feel the emotion described in the question, and 3 meaning the participant has extremely strong feelings. Total scale is 0 (no evidence of depression) to 63 (extreme depression). Negative change from baseline scores indicate improvement in level of depression. | Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment. | Posted | Least Squares Mean | Standard Error | units on a scale | Day 0 (baseline), Week 48 or termination visit |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Total Number of Falls During the Study | Participants recorded each time they fell during the study in a diary. | Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment, and who maintained diaries. | Posted | Median | Inter-Quartile Range | falls | Day 1 up to week 48 |
|
|
Day 1 to Week 48
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Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo tablet for up to 48 weeks. | 23 | 90 | 45 | 90 | ||
| EG001 | Rasagiline Mesylate | Rasagiline tablet, 1 mg/day for up to 48 weeks. | 29 | 84 | 41 | 84 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| CARDIAC FAILURE | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| CARDIOVASCULAR INSUFFICIENCY | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| LEFT VENTRICULAR FAILURE | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| SUPRAVENTRICULAR TACHYCARDIA | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| ABDOMINAL RIGIDITY | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| ACUTE ABDOMEN | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| CROHN'S DISEASE | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| GASTRIC ULCER | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| HAEMATEMESIS | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| CHILLS | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA (14.0) | Systematic Assessment |
| |
| ARTHRITIS INFECTIVE | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| CARBUNCLE | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| CYSTITIS | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| DEVICE RELATED INFECTION | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| LUNG INFECTION | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| FEMUR FRACTURE | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| HEAD INJURY | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| HIP FRACTURE | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| LACERATION | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| LUMBAR VERTEBRAL FRACTURE | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| PUBIS FRACTURE | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| PROSTATE CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| HYPOKINESIA | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| LOSS OF CONSCIOUSNESS | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| DELIRIUM | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| MENTAL STATUS CHANGES | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| SLEEP DISORDER | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| SUICIDE ATTEMPT | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| HAEMATURIA | Renal and urinary disorders | MedDRA (14.0) | Systematic Assessment |
| |
| URINARY RETENTION | Renal and urinary disorders | MedDRA (14.0) | Systematic Assessment |
| |
| URINARY TRACT OBSTRUCTION | Renal and urinary disorders | MedDRA (14.0) | Systematic Assessment |
| |
| BENIGN PROSTATIC HYPERPLASIA | Reproductive system and breast disorders | MedDRA (14.0) | Systematic Assessment |
| |
| PROSTATOMEGALY | Reproductive system and breast disorders | MedDRA (14.0) | Systematic Assessment |
| |
| CHOKING | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| DYSPHONIA | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| RESPIRATORY DISTRESS | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| CATARACT OPERATION | Surgical and medical procedures | MedDRA (14.0) | Systematic Assessment |
| |
| GASTROSTOMY | Surgical and medical procedures | MedDRA (14.0) | Systematic Assessment |
| |
| HIP ARTHROPLASTY | Surgical and medical procedures | MedDRA (14.0) | Systematic Assessment |
| |
| INGUINAL HERNIA REPAIR | Surgical and medical procedures | MedDRA (14.0) | Systematic Assessment |
| |
| KNEE ARTHROPLASTY | Surgical and medical procedures | MedDRA (14.0) | Systematic Assessment |
| |
| PROSTATECTOMY | Surgical and medical procedures | MedDRA (14.0) | Systematic Assessment |
| |
| TRACHEOSTOMY | Surgical and medical procedures | MedDRA (14.0) | Systematic Assessment |
| |
| TRANSURETHRAL PROSTATECTOMY | Surgical and medical procedures | MedDRA (14.0) | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
| |
| LABILE BLOOD PRESSURE | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
| |
| ORTHOSTATIC HYPOTENSION | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CONSTIPATION | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| SOMNOLENCE | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| ORTHOSTATIC HYPOTENSION | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Research | Teva Branded Pharmaceutical Products, R&D Inc. | 215-591-3000 | ustevatrials@tevapharm.com |
| ID | Term |
|---|---|
| D019578 | Multiple System Atrophy |
| ID | Term |
|---|---|
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C031967 | rasagiline |
Not provided
Not provided
Not provided
| Male |
|
| Black of African Heritage |
|
| Black or African American |
|
| Caucasian |
|
| Unknown |
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| United States |
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| France |
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| Hungary |
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| Canada |
|
| Spain |
|
| Austria |
|
| Israel |
|
| Germany |
|
| Netherlands |
|
| Italy |
|
| United Kingdom |
|
| Probable MSA-P |
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