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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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

Participant Flow

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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

Baseline Characteristics

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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]

174

Age
[Units: Years]
Mean (Standard Deviation)

64.9 (8.5)

65.1 (8.6)

65.0 (8.5)

Gender
[Units: Participants]

Female

Male

100

Race/Ethnicity, Customized
[Units: Participants]

Asian/Oriental

Black of African Heritage

Black or African American

Caucasian

166

Unknown

Region of Enrollment
[Units: Participants]

Portugal

United States

France

Hungary

Canada

Spain

Austria

Israel

Germany

Netherlands

Italy

United Kingdom

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

Probable MSA-P

^[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.

Outcome Measures

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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 ]

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2. Secondary:

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

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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 ]

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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 ]

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5. Secondary:

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

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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 ]

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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 ]

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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 ]

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9. Secondary:

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

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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 ]

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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 ]

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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 ]

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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 ]

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14. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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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More Information

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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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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:

Name/Title: Director, Clinical Research
Organization: Teva Branded Pharmaceutical Products, R&D Inc.
phone: 215-591-3000
e-mail: ustevatrials@tevapharm.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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

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