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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)

Primary Purpose

Multiple System Atrophy

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
rasagiline mesylate
placebo
Sponsored by
Teva Branded Pharmaceutical Products R&D, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple System Atrophy

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects over 30 years old with a diagnosis of Possible or Probable MSA of the parkinsonian subtype (MSA-P) according to The Gilman Criteria (2008).
  • Subjects who are less than 3 years from the time of documented MSA diagnosis.
  • Subjects with an anticipated survival of at least 3 years in the opinion of the investigator.
  • Subjects who are willing and able to give informed consent. Subjects who are not able to write may give verbal consent in the presence of at least one witness, and the witness should sign the informed consent form.

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:

    1. Speech impairment as assessed by a score of ≥ 3 on UMSARS question 1
    2. Swallowing impairment as assessed by a score of ≥ 3 on UMSARS question 2
    3. Impairment in ambulation as assessed by a score of ≥ 3 on UMSARS question 7
    4. Falling more frequently than once per week as assessed by a score of ≥ 3 on UMSARS question 8
  • 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.

Sites / Locations

  • Teva Investigational Site 1004
  • Teva Investigational Site 1014
  • Teva Investigational Site 1006
  • Teva Investigational Site 1010
  • Teva Investigational Site 1061
  • Teva Investigational Site 1012
  • Teva Investigational Site 1009
  • Teva Investigational Site 1003
  • Teva Investigational Site 1007
  • Teva Investigational Site 1011
  • Teva Investigational Site 1008
  • Teva Investigational Site 1001
  • Teva Investigational Site 1002
  • Teva Investigational Site 1013
  • Teva Investigational Site 1005
  • Teva Investigational Site 3305
  • Teva Investigational Site 3304
  • Teva Investigational Site 1109
  • Teva Investigational Site 1111
  • Teva Investigational Site 1108
  • Teva Investigational Site 1110
  • Teva Investigational Site 3503
  • Teva Investigational Site 3502
  • Teva Investigational Site 3206
  • Teva Investigational Site 3203
  • Teva Investigational Site 3201
  • Teva Investigational Site 3205
  • Teva Investigational Site 3204
  • Teva Investigational Site 3202
  • Teva Investigational Site 5101
  • Teva Investigational Site 5102
  • Teva Investigational Site 5103
  • Teva Investigational Site 8002
  • Teva Investigational Site 8004
  • Teva Investigational Site 8003
  • Teva Investigational Site 3006
  • Teva Investigational Site 3004
  • Teva Investigational Site 3005
  • Teva Investigational Site 3801
  • Teva Investigational Site 3802
  • Teva Investigational Site 3603
  • Teva Investigational Site 3101
  • Teva Investigational Site 3102
  • Teva Investigational Site 3103
  • Teva Investigational Site 3403
  • Teva Investigational Site 3401
  • Teva Investigational Site 3402

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

rasagiline mesylate

placebo

Arm Description

rasagiline tablet, 1 mg/day for up to 48 weeks.

placebo tablet for up to 48 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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".
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.
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).
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.
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: An addition of a new anti-parkinsonian or anti-orthostatic hypotension medication during study. 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.
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.
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).
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.
Total Number of Falls During the Study
Participants recorded each time they fell during the study in a diary.

Full Information

First Posted
September 15, 2009
Last Updated
February 10, 2015
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Collaborators
H. Lundbeck A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00977665
Brief Title
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)
Official Title
A Multi-centered, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Efficacy, Safety, and Tolerability of Rasagiline Mesylate 1 mg in Patients With Multiple System Atrophy of the Parkinsonian Subtype (MSA-P)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Collaborators
H. Lundbeck A/S

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To test the clinical effect of rasagiline on subjects with MSA of the parkinsonian subtype.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple System Atrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
174 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rasagiline mesylate
Arm Type
Experimental
Arm Description
rasagiline tablet, 1 mg/day for up to 48 weeks.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo tablet for up to 48 weeks.
Intervention Type
Drug
Intervention Name(s)
rasagiline mesylate
Other Intervention Name(s)
Azilect, TVP-1012
Intervention Description
rasagiline 1 mg tablet/day for 48 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo tablet for 48 weeks
Primary Outcome Measure Information:
Title
Change From Baseline to Week 48/Termination Visit in the Total Unified Multiple System Atrophy Rating Scale (UMSARS Part I and II)
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
Secondary Outcome Measure Information:
Title
Clinical Global Impression Improvement (CGI-I) at Week 48/Termination Visit
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
Title
Change From Baseline to Week 24 in Total Unified Multiple System Atrophy Rating Scale (UMSARS) Score
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
Title
Percentage of Participants Who Achieved a Score of >=3 on the Unified Multiple System Atrophy Rating Scale (UMSARS) Question #7 Regarding Ambulation
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
Title
Mean Score of the Composite Autonomic Symptom Scale Select (COMPASS_Select Change) at Week 48/Termination Visit
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
Title
Change From Baseline to Week 48/Termination Visit in the Multiple System Atrophy (MSA) Health-related Quality of Life (QoL) Scale
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
Title
Rate of Progression in Total Unified Multiple System Atrophy Rating Scale (UMSARS) Score From Baseline to Weeks 12-48
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
Title
Change From Baseline to Week 48 or Termination in UMSARS Subscores for Parts I, II and IV
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
Title
Change From Baseline to Week 12 in Total UMSARS Score for Symptomatic Effect
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
Title
Estimates for Time to Change in Anti-Parkinsonian or Anti-Orthostatis Hypotension Medications
Description
Change in anti-parkinsonian or anti-orthostatic hypotension medication is defined by at least one of the following events: An addition of a new anti-parkinsonian or anti-orthostatic hypotension medication during study. 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
Title
Change From Baseline to Week 48 or Termination in the Montreal Cognitive Assessment Scale (MoCA) Scale
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
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)
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
Title
Change From Baseline to Week 48 or Termination in the Beck Depression Inventory Scale (BDI-II)
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
Title
Total Number of Falls During the Study
Description
Participants recorded each time they fell during the study in a diary.
Time Frame
Day 1 up to week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects over 30 years old with a diagnosis of Possible or Probable MSA of the parkinsonian subtype (MSA-P) according to The Gilman Criteria (2008). Subjects who are less than 3 years from the time of documented MSA diagnosis. Subjects with an anticipated survival of at least 3 years in the opinion of the investigator. Subjects who are willing and able to give informed consent. Subjects who are not able to write may give verbal consent in the presence of at least one witness, and the witness should sign the informed consent form. 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: Speech impairment as assessed by a score of ≥ 3 on UMSARS question 1 Swallowing impairment as assessed by a score of ≥ 3 on UMSARS question 2 Impairment in ambulation as assessed by a score of ≥ 3 on UMSARS question 7 Falling more frequently than once per week as assessed by a score of ≥ 3 on UMSARS question 8 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Werner Poewe, Prof
Organizational Affiliation
Innsbruck Medical University, Innsbruck, Austria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Teva Investigational Site 1004
City
Irvine
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 1014
City
La Jolla
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 1006
City
Sunnyvale
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 1010
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
Teva Investigational Site 1061
City
Boca Raton
State/Province
Florida
Country
United States
Facility Name
Teva Investigational Site 1012
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Teva Investigational Site 1009
City
Worcester
State/Province
Massachusetts
Country
United States
Facility Name
Teva Investigational Site 1003
City
Ann Arbor
State/Province
Michigan
Country
United States
Facility Name
Teva Investigational Site 1007
City
Rochester
State/Province
Minnesota
Country
United States
Facility Name
Teva Investigational Site 1011
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Teva Investigational Site 1008
City
Rochester
State/Province
New York
Country
United States
Facility Name
Teva Investigational Site 1001
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
Teva Investigational Site 1002
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Teva Investigational Site 1013
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Teva Investigational Site 1005
City
Houston
State/Province
Texas
Country
United States
Facility Name
Teva Investigational Site 3305
City
Graz
Country
Austria
Facility Name
Teva Investigational Site 3304
City
Innsbruck
Country
Austria
Facility Name
Teva Investigational Site 1109
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Teva Investigational Site 1111
City
Greenfield Park
State/Province
Quebec
Country
Canada
Facility Name
Teva Investigational Site 1108
City
Montréal
State/Province
Quebec
Country
Canada
Facility Name
Teva Investigational Site 1110
City
Québec
State/Province
Quebec
Country
Canada
Facility Name
Teva Investigational Site 3503
City
Lille Cedex
Country
France
Facility Name
Teva Investigational Site 3502
City
Pessac
Country
France
Facility Name
Teva Investigational Site 3206
City
Dresden
Country
Germany
Facility Name
Teva Investigational Site 3203
City
Kiel
Country
Germany
Facility Name
Teva Investigational Site 3201
City
Marburg
Country
Germany
Facility Name
Teva Investigational Site 3205
City
Muenchen
Country
Germany
Facility Name
Teva Investigational Site 3204
City
Tuebingen
Country
Germany
Facility Name
Teva Investigational Site 3202
City
Ulm
Country
Germany
Facility Name
Teva Investigational Site 5101
City
Budapest
Country
Hungary
Facility Name
Teva Investigational Site 5102
City
Debrecen
Country
Hungary
Facility Name
Teva Investigational Site 5103
City
Miskolc
Country
Hungary
Facility Name
Teva Investigational Site 8002
City
Ramat -Gan
State/Province
IL
Country
Israel
Facility Name
Teva Investigational Site 8004
City
Haifa
Country
Israel
Facility Name
Teva Investigational Site 8003
City
Tel Aviv
Country
Israel
Facility Name
Teva Investigational Site 3006
City
Bologna
Country
Italy
Facility Name
Teva Investigational Site 3004
City
Roma
Country
Italy
Facility Name
Teva Investigational Site 3005
City
Venezia - Lido
Country
Italy
Facility Name
Teva Investigational Site 3801
City
Amersfoort
Country
Netherlands
Facility Name
Teva Investigational Site 3802
City
Sittard-Geleen
Country
Netherlands
Facility Name
Teva Investigational Site 3603
City
Lisbon
Country
Portugal
Facility Name
Teva Investigational Site 3101
City
Barcelona
Country
Spain
Facility Name
Teva Investigational Site 3102
City
Barcelona
Country
Spain
Facility Name
Teva Investigational Site 3103
City
Sevilla
Country
Spain
Facility Name
Teva Investigational Site 3403
City
Cardiff, Wales
Country
United Kingdom
Facility Name
Teva Investigational Site 3401
City
London
Country
United Kingdom
Facility Name
Teva Investigational Site 3402
City
Newcastle-Upon-Tyne
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
25498732
Citation
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.
Results Reference
derived

Learn more about this trial

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

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