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Trial record 14 of 91 for:    "Brain Diseases" AND "Multiple System Atrophy"

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)

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
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by (Responsible Party):
Teva Pharmaceutical Industries

Study Type Interventional
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
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
Hide Arm/Group Description 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
Arm/Group Title Rasagiline Mesylate Placebo Total
Hide Arm/Group Description 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
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
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
Number Analyzed 84 participants 90 participants 174 participants
Female
35
  41.7%
39
  43.3%
74
  42.5%
Male
49
  58.3%
51
  56.7%
100
  57.5%
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
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
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
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).

  • 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.
1.Primary Outcome
Title Change From Baseline to Week 48/Termination Visit in the Total Unified Multiple System Atrophy Rating Scale (UMSARS Part I and II)
Hide Description

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.

Time Frame Day 0 (baseline), Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Rasagiline Mesylate Placebo
Hide Arm/Group Description:
rasagiline tablet, 1 mg/day for up to 48 weeks.
placebo tablet for up to 48 weeks.
Overall Number of Participants Analyzed 81 90
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
7.2  (1.186) 7.8  (1.091)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rasagiline Mesylate, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6984
Comments A priori threshold for statistical significance is 0.05.
Method repeated measures model
Comments Fixed effects: categorical week in trial by treatment interaction, center, and baseline UMSARS score.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.603
Confidence Interval (2-Sided) 95%
-3.677 to 2.470
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Clinical Global Impression Improvement (CGI-I) at Week 48/Termination Visit
Hide Description

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.

Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Rasagiline Mesylate Placebo
Hide Arm/Group Description:
rasagiline tablet, 1 mg/day for up to 48 weeks.
placebo tablet for up to 48 weeks.
Overall Number of Participants Analyzed 80 88
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
4.9  (0.152) 4.8  (0.139)
3.Secondary Outcome
Title Change From Baseline to Week 24 in Total Unified Multiple System Atrophy Rating Scale (UMSARS) Score
Hide Description

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.

Time Frame Day 0 (baseline), Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Rasagiline Mesylate Placebo
Hide Arm/Group Description:
rasagiline tablet, 1 mg/day for up to 48 weeks.
placebo tablet for up to 48 weeks.
Overall Number of Participants Analyzed 81 90
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
3.8  (0.811) 3.0  (0.760)
4.Secondary Outcome
Title Percentage of Participants Who Achieved a Score of >=3 on the Unified Multiple System Atrophy Rating Scale (UMSARS) Question #7 Regarding Ambulation
Hide Description 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.
Time Frame up to week 48
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Rasagiline Mesylate Placebo
Hide Arm/Group Description:
rasagiline tablet, 1 mg/day for up to 48 weeks.
placebo tablet for up to 48 weeks.
Overall Number of Participants Analyzed 81 90
Measure Type: Number
Unit of Measure: percentage of participants
46.4 52.2
5.Secondary Outcome
Title Mean Score of the Composite Autonomic Symptom Scale Select (COMPASS_Select Change) at Week 48/Termination Visit
Hide Description 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.
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Rasagiline Mesylate Placebo
Hide Arm/Group Description:
rasagiline tablet, 1 mg/day for up to 48 weeks.
placebo tablet for up to 48 weeks.
Overall Number of Participants Analyzed 79 90
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
34.1  (4.342) 42.7  (4.025)
6.Secondary Outcome
Title Change From Baseline to Week 48/Termination Visit in the Multiple System Atrophy (MSA) Health-related Quality of Life (QoL) Scale
Hide Description 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".
Time Frame Day 0 (baseline), Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Rasagiline Mesylate Placebo
Hide Arm/Group Description:
rasagiline tablet, 1 mg/day for up to 48 weeks.
placebo tablet for up to 48 weeks.
Overall Number of Participants Analyzed 74 82
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
4.6  (2.877) 9.3  (2.720)
7.Secondary Outcome
Title Rate of Progression in Total Unified Multiple System Atrophy Rating Scale (UMSARS) Score From Baseline to Weeks 12-48
Hide Description

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.

Time Frame Day 0 (baseline), Weeks 12-48
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Rasagiline Mesylate Placebo
Hide Arm/Group Description:
rasagiline tablet, 1 mg/day for up to 48 weeks.
placebo tablet for up to 48 weeks.
Overall Number of Participants Analyzed 81 90
Mean (Standard Error)
Unit of Measure: units on a scale/week
0.1496  (0.02843) 0.1788  (0.02591)
8.Secondary Outcome
Title Change From Baseline to Week 48 or Termination in UMSARS Subscores for Parts I, II and IV
Hide Description 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).
Time Frame Day 0 (baseline), Week 48 or termination visit
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Rasagiline Mesylate Placebo
Hide Arm/Group Description:
rasagiline tablet, 1 mg/day for up to 48 weeks.
placebo tablet for up to 48 weeks.
Overall Number of Participants Analyzed 81 90
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
UMSARS Part I 3.8233  (0.6339) 4.3785  (0.5808)
UMSARS Part II 3.6478  (0.7017) 3.5068  (0.6445)
UMSARS Part IV 0.7100  (0.1040) 0.6763  (0.09523)
9.Secondary Outcome
Title Change From Baseline to Week 12 in Total UMSARS Score for Symptomatic Effect
Hide Description 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.
Time Frame Day 0 (baseline), Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Rasagiline Mesylate Placebo
Hide Arm/Group Description:
rasagiline tablet, 1 mg/day for up to 48 weeks.
placebo tablet for up to 48 weeks.
Overall Number of Participants Analyzed 79 88
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.875  (0.693) 1.574  (0.678)
10.Secondary Outcome
Title Estimates for Time to Change in Anti-Parkinsonian or Anti-Orthostatis Hypotension Medications
Hide Description

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.

Time Frame Day 0 (baseline) to Week 48 or termination visit
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Rasagiline Mesylate Placebo
Hide Arm/Group Description:
rasagiline tablet, 1 mg/day for up to 48 weeks.
placebo tablet for up to 48 weeks.
Overall Number of Participants Analyzed 84 90
Median (95% Confidence Interval)
Unit of Measure: days
246 [1] 
(162 to NA)
294 [1] 
(226 to NA)
[1]
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
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rasagiline Mesylate, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.189
Confidence Interval (2-Sided) 95%
0.646 to 2.186
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline to Week 48 or Termination in the Montreal Cognitive Assessment Scale (MoCA) Scale
Hide Description 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.
Time Frame Day 0 (baseline), Week 48 or termination visit
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Rasagiline Mesylate Placebo
Hide Arm/Group Description:
rasagiline tablet, 1 mg/day for up to 48 weeks.
placebo tablet for up to 48 weeks.
Overall Number of Participants Analyzed 73 82
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.1572  (0.4590) -0.5786  (0.4186)
12.Secondary Outcome
Title 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)
Hide Description

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).

Time Frame up to week 48
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Rasagiline Mesylate Placebo
Hide Arm/Group Description:
rasagiline tablet, 1 mg/day for up to 48 weeks.
placebo tablet for up to 48 weeks.
Overall Number of Participants Analyzed 81 90
Measure Type: Number
Unit of Measure: percentage of participants
Q1. Speech Impairment 35.7 30.0
Q2. Swallowing Impairment 3.6 6.7
Q8. Falling 19.0 15.6
13.Secondary Outcome
Title Change From Baseline to Week 48 or Termination in the Beck Depression Inventory Scale (BDI-II)
Hide Description 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.
Time Frame Day 0 (baseline), Week 48 or termination visit
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Rasagiline Mesylate Placebo
Hide Arm/Group Description:
rasagiline tablet, 1 mg/day for up to 48 weeks.
placebo tablet for up to 48 weeks.
Overall Number of Participants Analyzed 72 82
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.4894  (0.9988) 0.7145  (0.9241)
14.Secondary Outcome
Title Total Number of Falls During the Study
Hide Description Participants recorded each time they fell during the study in a diary.
Time Frame Day 1 up to week 48
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Rasagiline Mesylate Placebo
Hide Arm/Group Description:
rasagiline tablet, 1 mg/day for up to 48 weeks.
placebo tablet for up to 48 weeks.
Overall Number of Participants Analyzed 79 89
Median (Inter-Quartile Range)
Unit of Measure: falls
4.00
(1.00 to 14.00)
5.00
(1.00 to 10.00)
Time Frame Day 1 to Week 48
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Rasagiline Mesylate
Hide Arm/Group Description Placebo tablet for up to 48 weeks. Rasagiline tablet, 1 mg/day for up to 48 weeks.
All-Cause Mortality
Placebo Rasagiline Mesylate
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Rasagiline Mesylate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   23/90 (25.56%)      29/84 (34.52%)    
Blood and lymphatic system disorders     
ANAEMIA  1  1/90 (1.11%)  1 0/84 (0.00%)  0
Cardiac disorders     
CARDIAC FAILURE  1  1/90 (1.11%)  1 0/84 (0.00%)  0
CARDIOVASCULAR INSUFFICIENCY  1  0/90 (0.00%)  0 1/84 (1.19%)  1
CORONARY ARTERY DISEASE  1  1/90 (1.11%)  1 0/84 (0.00%)  0
LEFT VENTRICULAR FAILURE  1  1/90 (1.11%)  1 0/84 (0.00%)  0
SUPRAVENTRICULAR TACHYCARDIA  1  0/90 (0.00%)  0 1/84 (1.19%)  1
Gastrointestinal disorders     
ABDOMINAL PAIN UPPER  1  1/90 (1.11%)  1 0/84 (0.00%)  0
ABDOMINAL RIGIDITY  1  0/90 (0.00%)  0 1/84 (1.19%)  1
ACUTE ABDOMEN  1  0/90 (0.00%)  0 1/84 (1.19%)  1
CONSTIPATION  1  1/90 (1.11%)  1 1/84 (1.19%)  1
CROHN'S DISEASE  1  0/90 (0.00%)  0 1/84 (1.19%)  1
GASTRIC ULCER  1  1/90 (1.11%)  1 0/84 (0.00%)  0
HAEMATEMESIS  1  0/90 (0.00%)  0 1/84 (1.19%)  1
General disorders     
ASTHENIA  1  1/90 (1.11%)  1 0/84 (0.00%)  0
CHEST PAIN  1  0/90 (0.00%)  0 1/84 (1.19%)  1
CHILLS  1  1/90 (1.11%)  1 0/84 (0.00%)  0
FATIGUE  1  1/90 (1.11%)  1 0/84 (0.00%)  0
OEDEMA PERIPHERAL  1  1/90 (1.11%)  1 0/84 (0.00%)  0
PYREXIA  1  1/90 (1.11%)  1 1/84 (1.19%)  2
Hepatobiliary disorders     
CHOLECYSTITIS  1  1/90 (1.11%)  1 0/84 (0.00%)  0
Infections and infestations     
ARTHRITIS INFECTIVE  1  0/90 (0.00%)  0 1/84 (1.19%)  1
CARBUNCLE  1  0/90 (0.00%)  0 1/84 (1.19%)  1
CYSTITIS  1  0/90 (0.00%)  0 1/84 (1.19%)  1
DEVICE RELATED INFECTION  1  1/90 (1.11%)  1 0/84 (0.00%)  0
HERPES ZOSTER  1  1/90 (1.11%)  1 0/84 (0.00%)  0
LOWER RESPIRATORY TRACT INFECTION  1  0/90 (0.00%)  0 1/84 (1.19%)  1
LUNG INFECTION  1  0/90 (0.00%)  0 1/84 (1.19%)  1
NASOPHARYNGITIS  1  0/90 (0.00%)  0 1/84 (1.19%)  1
PNEUMONIA  1  1/90 (1.11%)  1 1/84 (1.19%)  1
URINARY TRACT INFECTION  1  1/90 (1.11%)  1 4/84 (4.76%)  6
Injury, poisoning and procedural complications     
FALL  1  3/90 (3.33%)  3 2/84 (2.38%)  2
FEMUR FRACTURE  1  2/90 (2.22%)  2 2/84 (2.38%)  2
HEAD INJURY  1  0/90 (0.00%)  0 2/84 (2.38%)  2
HIP FRACTURE  1  1/90 (1.11%)  1 1/84 (1.19%)  1
LACERATION  1  0/90 (0.00%)  0 1/84 (1.19%)  1
LUMBAR VERTEBRAL FRACTURE  1  1/90 (1.11%)  1 0/84 (0.00%)  0
PUBIS FRACTURE  1  1/90 (1.11%)  1 0/84 (0.00%)  0
Investigations     
WEIGHT DECREASED  1  1/90 (1.11%)  1 0/84 (0.00%)  0
Metabolism and nutrition disorders     
DECREASED APPETITE  1  1/90 (1.11%)  1 0/84 (0.00%)  0
HYPERGLYCAEMIA  1  1/90 (1.11%)  1 0/84 (0.00%)  0
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  1/90 (1.11%)  1 0/84 (0.00%)  0
BACK PAIN  1  1/90 (1.11%)  1 0/84 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
PROSTATE CANCER  1  1/90 (1.11%)  1 0/84 (0.00%)  0
Nervous system disorders     
HEADACHE  1  1/90 (1.11%)  1 0/84 (0.00%)  0
HYPOKINESIA  1  1/90 (1.11%)  1 0/84 (0.00%)  0
LOSS OF CONSCIOUSNESS  1  0/90 (0.00%)  0 1/84 (1.19%)  1
SYNCOPE  1  2/90 (2.22%)  2 2/84 (2.38%)  2
TRANSIENT ISCHAEMIC ATTACK  1  0/90 (0.00%)  0 1/84 (1.19%)  1
Psychiatric disorders     
DELIRIUM  1  0/90 (0.00%)  0 1/84 (1.19%)  1
MENTAL STATUS CHANGES  1  1/90 (1.11%)  1 0/84 (0.00%)  0
SLEEP DISORDER  1  1/90 (1.11%)  1 0/84 (0.00%)  0
SUICIDE ATTEMPT  1  1/90 (1.11%)  1 0/84 (0.00%)  0
Renal and urinary disorders     
HAEMATURIA  1  1/90 (1.11%)  1 0/84 (0.00%)  0
URINARY RETENTION  1  1/90 (1.11%)  1 1/84 (1.19%)  1
URINARY TRACT OBSTRUCTION  1  1/90 (1.11%)  1 0/84 (0.00%)  0
Reproductive system and breast disorders     
BENIGN PROSTATIC HYPERPLASIA  1  1/90 (1.11%)  1 1/84 (1.19%)  1
PROSTATOMEGALY  1  0/90 (0.00%)  0 1/84 (1.19%)  1
Respiratory, thoracic and mediastinal disorders     
CHOKING  1  1/90 (1.11%)  1 0/84 (0.00%)  0
DYSPHONIA  1  0/90 (0.00%)  0 1/84 (1.19%)  1
DYSPNOEA  1  1/90 (1.11%)  1 2/84 (2.38%)  3
PULMONARY EMBOLISM  1  1/90 (1.11%)  1 0/84 (0.00%)  0
RESPIRATORY DISTRESS  1  0/90 (0.00%)  0 1/84 (1.19%)  1
RESPIRATORY FAILURE  1  1/90 (1.11%)  1 3/84 (3.57%)  3
Surgical and medical procedures     
CATARACT OPERATION  1  1/90 (1.11%)  2 0/84 (0.00%)  0
GASTROSTOMY  1  0/90 (0.00%)  0 1/84 (1.19%)  1
HIP ARTHROPLASTY  1  0/90 (0.00%)  0 1/84 (1.19%)  1
INGUINAL HERNIA REPAIR  1  0/90 (0.00%)  0 1/84 (1.19%)  1
KNEE ARTHROPLASTY  1  0/90 (0.00%)  0 1/84 (1.19%)  1
PROSTATECTOMY  1  0/90 (0.00%)  0 1/84 (1.19%)  1
TRACHEOSTOMY  1  0/90 (0.00%)  0 1/84 (1.19%)  1
TRANSURETHRAL PROSTATECTOMY  1  0/90 (0.00%)  0 1/84 (1.19%)  1
Vascular disorders     
HYPERTENSION  1  1/90 (1.11%)  1 0/84 (0.00%)  0
LABILE BLOOD PRESSURE  1  0/90 (0.00%)  0 1/84 (1.19%)  1
ORTHOSTATIC HYPOTENSION  1  0/90 (0.00%)  0 3/84 (3.57%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Rasagiline Mesylate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   45/90 (50.00%)      41/84 (48.81%)    
Gastrointestinal disorders     
CONSTIPATION  1  5/90 (5.56%)  6 5/84 (5.95%)  5
General disorders     
OEDEMA PERIPHERAL  1  6/90 (6.67%)  6 9/84 (10.71%)  9
Infections and infestations     
NASOPHARYNGITIS  1  6/90 (6.67%)  6 4/84 (4.76%)  4
URINARY TRACT INFECTION  1  12/90 (13.33%)  22 6/84 (7.14%)  14
Injury, poisoning and procedural complications     
FALL  1  9/90 (10.00%)  12 5/84 (5.95%)  6
Nervous system disorders     
DIZZINESS  1  10/90 (11.11%)  14 10/84 (11.90%)  11
HEADACHE  1  7/90 (7.78%)  7 3/84 (3.57%)  3
SOMNOLENCE  1  5/90 (5.56%)  6 2/84 (2.38%)  2
Psychiatric disorders     
DEPRESSION  1  5/90 (5.56%)  5 1/84 (1.19%)  1
Vascular disorders     
ORTHOSTATIC HYPOTENSION  1  3/90 (3.33%)  3 6/84 (7.14%)  8
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.0)
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.
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
Layout table for Results Point of Contact information
Name/Title: Director, Clinical Research
Organization: Teva Branded Pharmaceutical Products, R&D Inc.
Phone: 215-591-3000
EMail: ustevatrials@tevapharm.com
Layout table for additonal information
Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT00977665     History of Changes
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