Trial Outcomes & Findings for 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) (NCT NCT00977665)
NCT ID: NCT00977665
Last Updated: 2015-02-26
Results Overview
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.
COMPLETED
PHASE2
174 participants
Day 0 (baseline), Week 48
2015-02-26
Participant Flow
Eligible participants were randomized in a 1:1 ratio to either active treatment or placebo.
Participant milestones
| Measure |
Rasagiline Mesylate
rasagiline tablet, 1 mg/day for up to 48 weeks.
|
Placebo
placebo tablet for up to 48 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
84
|
90
|
|
Overall Study
COMPLETED
|
63
|
75
|
|
Overall Study
NOT COMPLETED
|
21
|
15
|
Reasons for withdrawal
| Measure |
Rasagiline Mesylate
rasagiline tablet, 1 mg/day for up to 48 weeks.
|
Placebo
placebo tablet for up to 48 weeks.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
|
Overall Study
Physician Decision
|
2
|
1
|
|
Overall Study
Sponsor requested withdrawal
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Death
|
3
|
2
|
|
Overall Study
Adverse Event
|
14
|
7
|
|
Overall Study
Treatment failure
|
0
|
1
|
Baseline Characteristics
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)
Baseline characteristics by cohort
| Measure |
Rasagiline Mesylate
n=84 Participants
rasagiline tablet, 1 mg/day for up to 48 weeks.
|
Placebo
n=90 Participants
placebo tablet for up to 48 weeks.
|
Total
n=174 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.9 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
65.1 years
STANDARD_DEVIATION 8.6 • n=7 Participants
|
65.0 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian/Oriental
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black of African Heritage
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
81 participants
n=5 Participants
|
85 participants
n=7 Participants
|
166 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Portugal
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
16 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Region of Enrollment
France
|
9 participants
n=5 Participants
|
8 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
11 participants
n=5 Participants
|
10 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
9 participants
n=5 Participants
|
12 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
7 participants
n=5 Participants
|
12 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Weight
|
76.9 kg
STANDARD_DEVIATION 15.9 • n=5 Participants
|
76.8 kg
STANDARD_DEVIATION 15.5 • n=7 Participants
|
76.9 kg
STANDARD_DEVIATION 15.6 • n=5 Participants
|
|
Height
|
168.0 cm
STANDARD_DEVIATION 10.2 • n=5 Participants
|
169.0 cm
STANDARD_DEVIATION 8.9 • n=7 Participants
|
168.5 cm
STANDARD_DEVIATION 9.6 • n=5 Participants
|
|
Body Mass Index
|
27.2 kg/m^2
STANDARD_DEVIATION 4.4 • n=5 Participants
|
26.8 kg/m^2
STANDARD_DEVIATION 4.4 • n=7 Participants
|
27.0 kg/m^2
STANDARD_DEVIATION 4.4 • n=5 Participants
|
|
Multiple System Atrophy of the Parkinsonian Subtype (MSA-P)
Possible MSA-P
|
38 participants
n=5 Participants
|
55 participants
n=7 Participants
|
93 participants
n=5 Participants
|
|
Multiple System Atrophy of the Parkinsonian Subtype (MSA-P)
Probable MSA-P
|
46 participants
n=5 Participants
|
35 participants
n=7 Participants
|
81 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 (baseline), Week 48Population: 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.
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.
Outcome measures
| Measure |
Rasagiline Mesylate
n=81 Participants
rasagiline tablet, 1 mg/day for up to 48 weeks.
|
Placebo
n=90 Participants
placebo tablet for up to 48 weeks.
|
|---|---|---|
|
Change From Baseline to Week 48/Termination Visit in the Total Unified Multiple System Atrophy Rating Scale (UMSARS Part I and II)
|
7.2 units on a scale
Standard Error 1.186
|
7.8 units on a scale
Standard Error 1.091
|
SECONDARY outcome
Timeframe: Week 48Population: 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.
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.
Outcome measures
| Measure |
Rasagiline Mesylate
n=80 Participants
rasagiline tablet, 1 mg/day for up to 48 weeks.
|
Placebo
n=88 Participants
placebo tablet for up to 48 weeks.
|
|---|---|---|
|
Clinical Global Impression Improvement (CGI-I) at Week 48/Termination Visit
|
4.9 units on a scale
Standard Error 0.152
|
4.8 units on a scale
Standard Error 0.139
|
SECONDARY outcome
Timeframe: Day 0 (baseline), Week 24Population: 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.
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.
Outcome measures
| Measure |
Rasagiline Mesylate
n=81 Participants
rasagiline tablet, 1 mg/day for up to 48 weeks.
|
Placebo
n=90 Participants
placebo tablet for up to 48 weeks.
|
|---|---|---|
|
Change From Baseline to Week 24 in Total Unified Multiple System Atrophy Rating Scale (UMSARS) Score
|
3.8 units on a scale
Standard Error 0.811
|
3.0 units on a scale
Standard Error 0.760
|
SECONDARY outcome
Timeframe: up to week 48Population: 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.
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.
Outcome measures
| Measure |
Rasagiline Mesylate
n=81 Participants
rasagiline tablet, 1 mg/day for up to 48 weeks.
|
Placebo
n=90 Participants
placebo tablet for up to 48 weeks.
|
|---|---|---|
|
Percentage of Participants Who Achieved a Score of >=3 on the Unified Multiple System Atrophy Rating Scale (UMSARS) Question #7 Regarding Ambulation
|
46.4 percentage of participants
|
52.2 percentage of participants
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Rasagiline Mesylate
n=79 Participants
rasagiline tablet, 1 mg/day for up to 48 weeks.
|
Placebo
n=90 Participants
placebo tablet for up to 48 weeks.
|
|---|---|---|
|
Mean Score of the Composite Autonomic Symptom Scale Select (COMPASS_Select Change) at Week 48/Termination Visit
|
34.1 units on a scale
Standard Error 4.342
|
42.7 units on a scale
Standard Error 4.025
|
SECONDARY outcome
Timeframe: Day 0 (baseline), Week 48Population: 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.
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".
Outcome measures
| Measure |
Rasagiline Mesylate
n=74 Participants
rasagiline tablet, 1 mg/day for up to 48 weeks.
|
Placebo
n=82 Participants
placebo tablet for up to 48 weeks.
|
|---|---|---|
|
Change From Baseline to Week 48/Termination Visit in the Multiple System Atrophy (MSA) Health-related Quality of Life (QoL) Scale
|
4.6 units on a scale
Standard Error 2.877
|
9.3 units on a scale
Standard Error 2.720
|
SECONDARY outcome
Timeframe: Day 0 (baseline), Weeks 12-48Population: 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.
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.
Outcome measures
| Measure |
Rasagiline Mesylate
n=81 Participants
rasagiline tablet, 1 mg/day for up to 48 weeks.
|
Placebo
n=90 Participants
placebo tablet for up to 48 weeks.
|
|---|---|---|
|
Rate of Progression in Total Unified Multiple System Atrophy Rating Scale (UMSARS) Score From Baseline to Weeks 12-48
|
0.1496 units on a scale/week
Standard Error 0.02843
|
0.1788 units on a scale/week
Standard Error 0.02591
|
SECONDARY outcome
Timeframe: Day 0 (baseline), Week 48 or termination visitPopulation: 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.
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).
Outcome measures
| Measure |
Rasagiline Mesylate
n=81 Participants
rasagiline tablet, 1 mg/day for up to 48 weeks.
|
Placebo
n=90 Participants
placebo tablet for up to 48 weeks.
|
|---|---|---|
|
Change From Baseline to Week 48 or Termination in UMSARS Subscores for Parts I, II and IV
UMSARS Part I
|
3.8233 units on a scale
Standard Error 0.6339
|
4.3785 units on a scale
Standard Error 0.5808
|
|
Change From Baseline to Week 48 or Termination in UMSARS Subscores for Parts I, II and IV
UMSARS Part II
|
3.6478 units on a scale
Standard Error 0.7017
|
3.5068 units on a scale
Standard Error 0.6445
|
|
Change From Baseline to Week 48 or Termination in UMSARS Subscores for Parts I, II and IV
UMSARS Part IV
|
0.7100 units on a scale
Standard Error 0.1040
|
0.6763 units on a scale
Standard Error 0.09523
|
SECONDARY outcome
Timeframe: Day 0 (baseline), Week 12Population: 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.
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.
Outcome measures
| Measure |
Rasagiline Mesylate
n=79 Participants
rasagiline tablet, 1 mg/day for up to 48 weeks.
|
Placebo
n=88 Participants
placebo tablet for up to 48 weeks.
|
|---|---|---|
|
Change From Baseline to Week 12 in Total UMSARS Score for Symptomatic Effect
|
1.875 units on a scale
Standard Deviation 0.693
|
1.574 units on a scale
Standard Deviation 0.678
|
SECONDARY outcome
Timeframe: Day 0 (baseline) to Week 48 or termination visitPopulation: 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.
Change in anti-parkinsonian or anti-orthostatic hypotension medication is defined by at least one of the following events: 1. An addition of a new anti-parkinsonian or anti-orthostatic hypotension medication during study. 2. Dose modification of anti-parkinsonian or anti-orthostatic hypotension concomitant medications reflecting disease progression. 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.
Outcome measures
| Measure |
Rasagiline Mesylate
n=84 Participants
rasagiline tablet, 1 mg/day for up to 48 weeks.
|
Placebo
n=90 Participants
placebo tablet for up to 48 weeks.
|
|---|---|---|
|
Estimates for Time to Change in Anti-Parkinsonian or Anti-Orthostatis Hypotension Medications
|
246 days
Interval 162.0 to
Not enough participants had an event for which to a median or upper 95% CI for the 25th percentile can be estimated, hence only the 25th percentile estimate and the lower 95% CI for the 25th percentile are presented
|
294 days
Interval 226.0 to
Not enough participants had an event for which to a median or upper 95% CI for the 25th percentile can be estimated, hence only the 25th percentile estimate and the lower 95% CI for the 25th percentile are presented
|
SECONDARY outcome
Timeframe: Day 0 (baseline), Week 48 or termination visitPopulation: 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.
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.
Outcome measures
| Measure |
Rasagiline Mesylate
n=73 Participants
rasagiline tablet, 1 mg/day for up to 48 weeks.
|
Placebo
n=82 Participants
placebo tablet for up to 48 weeks.
|
|---|---|---|
|
Change From Baseline to Week 48 or Termination in the Montreal Cognitive Assessment Scale (MoCA) Scale
|
-1.1572 units on a scale
Standard Error 0.4590
|
-0.5786 units on a scale
Standard Error 0.4186
|
SECONDARY outcome
Timeframe: up to week 48Population: 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.
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).
Outcome measures
| Measure |
Rasagiline Mesylate
n=81 Participants
rasagiline tablet, 1 mg/day for up to 48 weeks.
|
Placebo
n=90 Participants
placebo tablet for up to 48 weeks.
|
|---|---|---|
|
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)
Q8. Falling
|
19.0 percentage of participants
|
15.6 percentage of participants
|
|
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)
Q1. Speech Impairment
|
35.7 percentage of participants
|
30.0 percentage of participants
|
|
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)
Q2. Swallowing Impairment
|
3.6 percentage of participants
|
6.7 percentage of participants
|
SECONDARY outcome
Timeframe: Day 0 (baseline), Week 48 or termination visitPopulation: 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.
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.
Outcome measures
| Measure |
Rasagiline Mesylate
n=72 Participants
rasagiline tablet, 1 mg/day for up to 48 weeks.
|
Placebo
n=82 Participants
placebo tablet for up to 48 weeks.
|
|---|---|---|
|
Change From Baseline to Week 48 or Termination in the Beck Depression Inventory Scale (BDI-II)
|
0.4894 units on a scale
Standard Error 0.9988
|
0.7145 units on a scale
Standard Error 0.9241
|
SECONDARY outcome
Timeframe: Day 1 up to week 48Population: 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.
Participants recorded each time they fell during the study in a diary.
Outcome measures
| Measure |
Rasagiline Mesylate
n=79 Participants
rasagiline tablet, 1 mg/day for up to 48 weeks.
|
Placebo
n=89 Participants
placebo tablet for up to 48 weeks.
|
|---|---|---|
|
Total Number of Falls During the Study
|
4.00 falls
Interval 1.0 to 14.0
|
5.00 falls
Interval 1.0 to 10.0
|
Adverse Events
Placebo
Rasagiline Mesylate
Serious adverse events
| Measure |
Placebo
n=90 participants at risk
Placebo tablet for up to 48 weeks.
|
Rasagiline Mesylate
n=84 participants at risk
Rasagiline tablet, 1 mg/day for up to 48 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
1.1%
1/90 • Number of events 1 • Day 1 to Week 48
|
0.00%
0/84 • Day 1 to Week 48
|
|
Cardiac disorders
CARDIAC FAILURE
|
1.1%
1/90 • Number of events 1 • Day 1 to Week 48
|
0.00%
0/84 • Day 1 to Week 48
|
|
Cardiac disorders
CARDIOVASCULAR INSUFFICIENCY
|
0.00%
0/90 • Day 1 to Week 48
|
1.2%
1/84 • Number of events 1 • Day 1 to Week 48
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
1.1%
1/90 • Number of events 1 • Day 1 to Week 48
|
0.00%
0/84 • Day 1 to Week 48
|
|
Cardiac disorders
LEFT VENTRICULAR FAILURE
|
1.1%
1/90 • Number of events 1 • Day 1 to Week 48
|
0.00%
0/84 • Day 1 to Week 48
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
0.00%
0/90 • Day 1 to Week 48
|
1.2%
1/84 • Number of events 1 • Day 1 to Week 48
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
1.1%
1/90 • Number of events 1 • Day 1 to Week 48
|
0.00%
0/84 • Day 1 to Week 48
|
|
Gastrointestinal disorders
ABDOMINAL RIGIDITY
|
0.00%
0/90 • Day 1 to Week 48
|
1.2%
1/84 • Number of events 1 • Day 1 to Week 48
|
|
Gastrointestinal disorders
ACUTE ABDOMEN
|
0.00%
0/90 • Day 1 to Week 48
|
1.2%
1/84 • Number of events 1 • Day 1 to Week 48
|
|
Gastrointestinal disorders
CONSTIPATION
|
1.1%
1/90 • Number of events 1 • Day 1 to Week 48
|
1.2%
1/84 • Number of events 1 • Day 1 to Week 48
|
|
Gastrointestinal disorders
CROHN'S DISEASE
|
0.00%
0/90 • Day 1 to Week 48
|
1.2%
1/84 • Number of events 1 • Day 1 to Week 48
|
|
Gastrointestinal disorders
GASTRIC ULCER
|
1.1%
1/90 • Number of events 1 • Day 1 to Week 48
|
0.00%
0/84 • Day 1 to Week 48
|
|
Gastrointestinal disorders
HAEMATEMESIS
|
0.00%
0/90 • Day 1 to Week 48
|
1.2%
1/84 • Number of events 1 • Day 1 to Week 48
|
|
General disorders
ASTHENIA
|
1.1%
1/90 • Number of events 1 • Day 1 to Week 48
|
0.00%
0/84 • Day 1 to Week 48
|
|
General disorders
CHEST PAIN
|
0.00%
0/90 • Day 1 to Week 48
|
1.2%
1/84 • Number of events 1 • Day 1 to Week 48
|
|
General disorders
CHILLS
|
1.1%
1/90 • Number of events 1 • Day 1 to Week 48
|
0.00%
0/84 • Day 1 to Week 48
|
|
General disorders
FATIGUE
|
1.1%
1/90 • Number of events 1 • Day 1 to Week 48
|
0.00%
0/84 • Day 1 to Week 48
|
|
General disorders
OEDEMA PERIPHERAL
|
1.1%
1/90 • Number of events 1 • Day 1 to Week 48
|
0.00%
0/84 • Day 1 to Week 48
|
|
General disorders
PYREXIA
|
1.1%
1/90 • Number of events 1 • Day 1 to Week 48
|
1.2%
1/84 • Number of events 2 • Day 1 to Week 48
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
1.1%
1/90 • Number of events 1 • Day 1 to Week 48
|
0.00%
0/84 • Day 1 to Week 48
|
|
Infections and infestations
ARTHRITIS INFECTIVE
|
0.00%
0/90 • Day 1 to Week 48
|
1.2%
1/84 • Number of events 1 • Day 1 to Week 48
|
|
Infections and infestations
CARBUNCLE
|
0.00%
0/90 • Day 1 to Week 48
|
1.2%
1/84 • Number of events 1 • Day 1 to Week 48
|
|
Infections and infestations
CYSTITIS
|
0.00%
0/90 • Day 1 to Week 48
|
1.2%
1/84 • Number of events 1 • Day 1 to Week 48
|
|
Infections and infestations
DEVICE RELATED INFECTION
|
1.1%
1/90 • Number of events 1 • Day 1 to Week 48
|
0.00%
0/84 • Day 1 to Week 48
|
|
Infections and infestations
HERPES ZOSTER
|
1.1%
1/90 • Number of events 1 • Day 1 to Week 48
|
0.00%
0/84 • Day 1 to Week 48
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
0.00%
0/90 • Day 1 to Week 48
|
1.2%
1/84 • Number of events 1 • Day 1 to Week 48
|
|
Infections and infestations
LUNG INFECTION
|
0.00%
0/90 • Day 1 to Week 48
|
1.2%
1/84 • Number of events 1 • Day 1 to Week 48
|
|
Infections and infestations
NASOPHARYNGITIS
|
0.00%
0/90 • Day 1 to Week 48
|
1.2%
1/84 • Number of events 1 • Day 1 to Week 48
|
|
Infections and infestations
PNEUMONIA
|
1.1%
1/90 • Number of events 1 • Day 1 to Week 48
|
1.2%
1/84 • Number of events 1 • Day 1 to Week 48
|
|
Infections and infestations
URINARY TRACT INFECTION
|
1.1%
1/90 • Number of events 1 • Day 1 to Week 48
|
4.8%
4/84 • Number of events 6 • Day 1 to Week 48
|
|
Injury, poisoning and procedural complications
FALL
|
3.3%
3/90 • Number of events 3 • Day 1 to Week 48
|
2.4%
2/84 • Number of events 2 • Day 1 to Week 48
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
2.2%
2/90 • Number of events 2 • Day 1 to Week 48
|
2.4%
2/84 • Number of events 2 • Day 1 to Week 48
|
|
Injury, poisoning and procedural complications
HEAD INJURY
|
0.00%
0/90 • Day 1 to Week 48
|
2.4%
2/84 • Number of events 2 • Day 1 to Week 48
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
1.1%
1/90 • Number of events 1 • Day 1 to Week 48
|
1.2%
1/84 • Number of events 1 • Day 1 to Week 48
|
|
Injury, poisoning and procedural complications
LACERATION
|
0.00%
0/90 • Day 1 to Week 48
|
1.2%
1/84 • Number of events 1 • Day 1 to Week 48
|
|
Injury, poisoning and procedural complications
LUMBAR VERTEBRAL FRACTURE
|
1.1%
1/90 • Number of events 1 • Day 1 to Week 48
|
0.00%
0/84 • Day 1 to Week 48
|
|
Injury, poisoning and procedural complications
PUBIS FRACTURE
|
1.1%
1/90 • Number of events 1 • Day 1 to Week 48
|
0.00%
0/84 • Day 1 to Week 48
|
|
Investigations
WEIGHT DECREASED
|
1.1%
1/90 • Number of events 1 • Day 1 to Week 48
|
0.00%
0/84 • Day 1 to Week 48
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
1.1%
1/90 • Number of events 1 • Day 1 to Week 48
|
0.00%
0/84 • Day 1 to Week 48
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
1.1%
1/90 • Number of events 1 • Day 1 to Week 48
|
0.00%
0/84 • Day 1 to Week 48
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
1.1%
1/90 • Number of events 1 • Day 1 to Week 48
|
0.00%
0/84 • Day 1 to Week 48
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
1.1%
1/90 • Number of events 1 • Day 1 to Week 48
|
0.00%
0/84 • Day 1 to Week 48
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
|
1.1%
1/90 • Number of events 1 • Day 1 to Week 48
|
0.00%
0/84 • Day 1 to Week 48
|
|
Nervous system disorders
HEADACHE
|
1.1%
1/90 • Number of events 1 • Day 1 to Week 48
|
0.00%
0/84 • Day 1 to Week 48
|
|
Nervous system disorders
HYPOKINESIA
|
1.1%
1/90 • Number of events 1 • Day 1 to Week 48
|
0.00%
0/84 • Day 1 to Week 48
|
|
Nervous system disorders
LOSS OF CONSCIOUSNESS
|
0.00%
0/90 • Day 1 to Week 48
|
1.2%
1/84 • Number of events 1 • Day 1 to Week 48
|
|
Nervous system disorders
SYNCOPE
|
2.2%
2/90 • Number of events 2 • Day 1 to Week 48
|
2.4%
2/84 • Number of events 2 • Day 1 to Week 48
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.00%
0/90 • Day 1 to Week 48
|
1.2%
1/84 • Number of events 1 • Day 1 to Week 48
|
|
Psychiatric disorders
DELIRIUM
|
0.00%
0/90 • Day 1 to Week 48
|
1.2%
1/84 • Number of events 1 • Day 1 to Week 48
|
|
Psychiatric disorders
MENTAL STATUS CHANGES
|
1.1%
1/90 • Number of events 1 • Day 1 to Week 48
|
0.00%
0/84 • Day 1 to Week 48
|
|
Psychiatric disorders
SLEEP DISORDER
|
1.1%
1/90 • Number of events 1 • Day 1 to Week 48
|
0.00%
0/84 • Day 1 to Week 48
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
1.1%
1/90 • Number of events 1 • Day 1 to Week 48
|
0.00%
0/84 • Day 1 to Week 48
|
|
Renal and urinary disorders
HAEMATURIA
|
1.1%
1/90 • Number of events 1 • Day 1 to Week 48
|
0.00%
0/84 • Day 1 to Week 48
|
|
Renal and urinary disorders
URINARY RETENTION
|
1.1%
1/90 • Number of events 1 • Day 1 to Week 48
|
1.2%
1/84 • Number of events 1 • Day 1 to Week 48
|
|
Renal and urinary disorders
URINARY TRACT OBSTRUCTION
|
1.1%
1/90 • Number of events 1 • Day 1 to Week 48
|
0.00%
0/84 • Day 1 to Week 48
|
|
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERPLASIA
|
1.1%
1/90 • Number of events 1 • Day 1 to Week 48
|
1.2%
1/84 • Number of events 1 • Day 1 to Week 48
|
|
Reproductive system and breast disorders
PROSTATOMEGALY
|
0.00%
0/90 • Day 1 to Week 48
|
1.2%
1/84 • Number of events 1 • Day 1 to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
CHOKING
|
1.1%
1/90 • Number of events 1 • Day 1 to Week 48
|
0.00%
0/84 • Day 1 to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
0.00%
0/90 • Day 1 to Week 48
|
1.2%
1/84 • Number of events 1 • Day 1 to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
1.1%
1/90 • Number of events 1 • Day 1 to Week 48
|
2.4%
2/84 • Number of events 3 • Day 1 to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
1.1%
1/90 • Number of events 1 • Day 1 to Week 48
|
0.00%
0/84 • Day 1 to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISTRESS
|
0.00%
0/90 • Day 1 to Week 48
|
1.2%
1/84 • Number of events 1 • Day 1 to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
1.1%
1/90 • Number of events 1 • Day 1 to Week 48
|
3.6%
3/84 • Number of events 3 • Day 1 to Week 48
|
|
Surgical and medical procedures
CATARACT OPERATION
|
1.1%
1/90 • Number of events 2 • Day 1 to Week 48
|
0.00%
0/84 • Day 1 to Week 48
|
|
Surgical and medical procedures
GASTROSTOMY
|
0.00%
0/90 • Day 1 to Week 48
|
1.2%
1/84 • Number of events 1 • Day 1 to Week 48
|
|
Surgical and medical procedures
HIP ARTHROPLASTY
|
0.00%
0/90 • Day 1 to Week 48
|
1.2%
1/84 • Number of events 1 • Day 1 to Week 48
|
|
Surgical and medical procedures
INGUINAL HERNIA REPAIR
|
0.00%
0/90 • Day 1 to Week 48
|
1.2%
1/84 • Number of events 1 • Day 1 to Week 48
|
|
Surgical and medical procedures
KNEE ARTHROPLASTY
|
0.00%
0/90 • Day 1 to Week 48
|
1.2%
1/84 • Number of events 1 • Day 1 to Week 48
|
|
Surgical and medical procedures
PROSTATECTOMY
|
0.00%
0/90 • Day 1 to Week 48
|
1.2%
1/84 • Number of events 1 • Day 1 to Week 48
|
|
Surgical and medical procedures
TRACHEOSTOMY
|
0.00%
0/90 • Day 1 to Week 48
|
1.2%
1/84 • Number of events 1 • Day 1 to Week 48
|
|
Surgical and medical procedures
TRANSURETHRAL PROSTATECTOMY
|
0.00%
0/90 • Day 1 to Week 48
|
1.2%
1/84 • Number of events 1 • Day 1 to Week 48
|
|
Vascular disorders
HYPERTENSION
|
1.1%
1/90 • Number of events 1 • Day 1 to Week 48
|
0.00%
0/84 • Day 1 to Week 48
|
|
Vascular disorders
LABILE BLOOD PRESSURE
|
0.00%
0/90 • Day 1 to Week 48
|
1.2%
1/84 • Number of events 1 • Day 1 to Week 48
|
|
Vascular disorders
ORTHOSTATIC HYPOTENSION
|
0.00%
0/90 • Day 1 to Week 48
|
3.6%
3/84 • Number of events 3 • Day 1 to Week 48
|
Other adverse events
| Measure |
Placebo
n=90 participants at risk
Placebo tablet for up to 48 weeks.
|
Rasagiline Mesylate
n=84 participants at risk
Rasagiline tablet, 1 mg/day for up to 48 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
CONSTIPATION
|
5.6%
5/90 • Number of events 6 • Day 1 to Week 48
|
6.0%
5/84 • Number of events 5 • Day 1 to Week 48
|
|
General disorders
OEDEMA PERIPHERAL
|
6.7%
6/90 • Number of events 6 • Day 1 to Week 48
|
10.7%
9/84 • Number of events 9 • Day 1 to Week 48
|
|
Infections and infestations
NASOPHARYNGITIS
|
6.7%
6/90 • Number of events 6 • Day 1 to Week 48
|
4.8%
4/84 • Number of events 4 • Day 1 to Week 48
|
|
Infections and infestations
URINARY TRACT INFECTION
|
13.3%
12/90 • Number of events 22 • Day 1 to Week 48
|
7.1%
6/84 • Number of events 14 • Day 1 to Week 48
|
|
Injury, poisoning and procedural complications
FALL
|
10.0%
9/90 • Number of events 12 • Day 1 to Week 48
|
6.0%
5/84 • Number of events 6 • Day 1 to Week 48
|
|
Nervous system disorders
DIZZINESS
|
11.1%
10/90 • Number of events 14 • Day 1 to Week 48
|
11.9%
10/84 • Number of events 11 • Day 1 to Week 48
|
|
Nervous system disorders
HEADACHE
|
7.8%
7/90 • Number of events 7 • Day 1 to Week 48
|
3.6%
3/84 • Number of events 3 • Day 1 to Week 48
|
|
Nervous system disorders
SOMNOLENCE
|
5.6%
5/90 • Number of events 6 • Day 1 to Week 48
|
2.4%
2/84 • Number of events 2 • Day 1 to Week 48
|
|
Psychiatric disorders
DEPRESSION
|
5.6%
5/90 • Number of events 5 • Day 1 to Week 48
|
1.2%
1/84 • Number of events 1 • Day 1 to Week 48
|
|
Vascular disorders
ORTHOSTATIC HYPOTENSION
|
3.3%
3/90 • Number of events 3 • Day 1 to Week 48
|
7.1%
6/84 • Number of events 8 • Day 1 to Week 48
|
Additional Information
Director, Clinical Research
Teva Branded Pharmaceutical Products, R&D Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER