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)

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligible participants were randomized in a 1:1 ratio to either active treatment or placebo.

Reporting Groups

	Description
Rasagiline Mesylate	rasagiline tablet, 1 mg/day for up to 48 weeks.
Placebo	placebo tablet for up to 48 weeks.

Participant Flow:   Overall Study

	Rasagiline Mesylate	Placebo
STARTED	84	90
COMPLETED	63	75
NOT COMPLETED	21	15
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

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Rasagiline Mesylate	rasagiline tablet, 1 mg/day for up to 48 weeks.
Placebo	placebo tablet for up to 48 weeks.
Total	Total of all reporting groups

Baseline Measures

	Rasagiline Mesylate	Placebo	Total
Overall Participants Analyzed  [Units: Participants]	84	90	174
Age  [Units: Years] Mean (Standard Deviation)	64.9  (8.5)	65.1  (8.6)	65.0  (8.5)
Gender  [Units: Participants]
Female	35	39	74
Male	49	51	100
Race/Ethnicity, Customized  [Units: 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  [Units: 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  [Units: Kg] Mean (Standard Deviation)	76.9  (15.9)	76.8  (15.5)	76.9  (15.6)
Height  [Units: Cm] Mean (Standard Deviation)	168.0  (10.2)	169.0  (8.9)	168.5  (9.6)
Body Mass Index  [Units: Kg/m^2] Mean (Standard Deviation)	27.2  (4.4)	26.8  (4.4)	27.0  (4.4)
Multiple System Atrophy of the Parkinsonian Subtype (MSA-P) [1]  [Units: Participants]
Possible MSA-P	38	55	93
Probable MSA-P	46	35	81
[1] 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:

Change From Baseline to Week 48/Termination Visit in the Total Unified Multiple System Atrophy Rating Scale (UMSARS Part I and II)   [ Time Frame: Day 0 (baseline), Week 48 ]

2.  Secondary:

Clinical Global Impression Improvement (CGI-I) at Week 48/Termination Visit   [ Time Frame: Week 48 ]

3.  Secondary:

Change From Baseline to Week 24 in Total Unified Multiple System Atrophy Rating Scale (UMSARS) Score   [ Time Frame: Day 0 (baseline), Week 24 ]

4.  Secondary:

Percentage of Participants Who Achieved a Score of >=3 on the Unified Multiple System Atrophy Rating Scale (UMSARS) Question #7 Regarding Ambulation   [ Time Frame: up to week 48 ]

5.  Secondary:

Mean Score of the Composite Autonomic Symptom Scale Select (COMPASS_Select Change) at Week 48/Termination Visit   [ Time Frame: 48 weeks ]

6.  Secondary:

Change From Baseline to Week 48/Termination Visit in the Multiple System Atrophy (MSA) Health-related Quality of Life (QoL) Scale   [ Time Frame: Day 0 (baseline), Week 48 ]

7.  Secondary:

Rate of Progression in Total Unified Multiple System Atrophy Rating Scale (UMSARS) Score From Baseline to Weeks 12-48   [ Time Frame: Day 0 (baseline), Weeks 12-48 ]

8.  Secondary:

Change From Baseline to Week 48 or Termination in UMSARS Subscores for Parts I, II and IV   [ Time Frame: Day 0 (baseline), Week 48 or termination visit ]

9.  Secondary:

Change From Baseline to Week 12 in Total UMSARS Score for Symptomatic Effect   [ Time Frame: Day 0 (baseline), Week 12 ]

10.  Secondary:

Estimates for Time to Change in Anti-Parkinsonian or Anti-Orthostatis Hypotension Medications   [ Time Frame: Day 0 (baseline) to Week 48 or termination visit ]

11.  Secondary:

Change From Baseline to Week 48 or Termination in the Montreal Cognitive Assessment Scale (MoCA) Scale   [ Time Frame: Day 0 (baseline), Week 48 or termination visit ]

12.  Secondary:

Percentage of Participants Who Achieved a Score of >=3 on the Unified Multiple System Atrophy Rating Scale (UMSARS) Question #1 (Speech Impairment), Question #2 (Swallowing Impairment) and Question #8 (Falling)   [ Time Frame: up to week 48 ]

13.  Secondary:

Change From Baseline to Week 48 or Termination in the Beck Depression Inventory Scale (BDI-II)   [ Time Frame: Day 0 (baseline), Week 48 or termination visit ]

14.  Secondary:

Total Number of Falls During the Study   [ Time Frame: Day 1 up to week 48 ]

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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