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Study of BHV-3241 in Subjects With Multiple System Atrophy (M-STAR)

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: NCT03952806
Recruitment Status : Completed
First Posted : May 16, 2019
Last Update Posted : January 20, 2023
Sponsor:
Information provided by (Responsible Party):
Biohaven Pharmaceuticals, Inc.

Study Description
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Brief Summary:
The purpose of this study is to compare the efficacy of BHV-3241 versus placebo in subjects with Multiple System Atrophy

Condition or disease Intervention/treatment Phase
Multiple System Atrophy Drug: Verdiperstat Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 336 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Double-blind to Sponsor, Investigator and Subject
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel- Group Study to Evaluate the Efficacy and Safety of BHV-3241 in Subjects With Multiple System Atrophy (M-STAR Study)
Actual Study Start Date : July 29, 2019
Actual Primary Completion Date : July 29, 2021
Actual Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1: BHV-3241- Experimental Drug: Verdiperstat
300mg 2 -oral- capsules, BID
Placebo Comparator: Arm 2: Placebo Comparator Drug: Placebo
Matching placebo


Outcome Measures
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Primary Outcome Measures :
  1. Evaluate the efficacy of BHV-3241, compared to placebo, as measured by a change from baseline in a modified Unified MSA Rating Scale (UMSARS) score at Week 48. [ Time Frame: Change from Baseline to Week 48 ]
    Measured by a change from baseline in a modified Unified MSA Rating Scale (UMSARS) score.

  2. Assess the safety and tolerability of BHV-3241, relative to placebo, in subjects with MSA. [ Time Frame: Change from Baseline to Week 48 ]
    Measured by the difference in amount and severity of adverse events including clinically significant abnormal laboratory values, and electrocardiogram (ECG) results.


Secondary Outcome Measures :
  1. Evaluate the efficacy of BHV-3241, compared to placebo, as measured by the Clinical Global Impression of Improvement (CGI-I) score at Week 48. [ Time Frame: Change from Baseline Week 48 ]
    Measured by the Clinical Global Impression of Improvement (CGI-I) score

  2. Evaluate the impact of BHV-3241 on quality of life, compared to placebo, as measured by a change from baseline in the motor and non-motor subscales of the MSA- QoL scale at Week 48. [ Time Frame: Change from Baseline to Week 48 ]
    Measured by a change from baseline in the motor and non-motor subscales of the MSA- QoL scale.

  3. Evaluate the efficacy of BHV-3241, compared to placebo, as measured by a change from baseline in the UMSARS Part I and Part II total score at Week 48. [ Time Frame: Change from Baseline to Week 48 ]
    Measured by a change from baseline in the UMSARS Part I and Part II total score


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of probable or possible MSA according to consensus clinical criteria (Gilman et al 2008), including subjects with MSA of either subtype (MSA-P or MSA-C).
  2. Able to ambulate without the assistance of another person, defined as the ability to take at least 10 steps. Use of assistive devices (e.g., walker or cane) is allowed.
  3. Anticipated survival of at least 3 years at the time of Screening, as judged by the Investigator.

Exclusion Criteria:

  1. Any condition that would interfere with the subject's ability to comply with study instructions, place the subject at unacceptable risk, and/or confound the interpretation of safety or efficacy data from the study, as judged by the Investigator.
  2. Diagnosis of neurological disorders, other than MSA.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03952806


Locations
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Sponsors and Collaborators
Biohaven Pharmaceuticals, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Biohaven Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03952806    
Other Study ID Numbers: BHV3241-301
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: January 20, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Biohaven Pharmaceuticals, Inc.:
Multiple System Atrophy (MSA)
Additional relevant MeSH terms:
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Multiple System Atrophy
Shy-Drager Syndrome
Atrophy
Pathological Conditions, Anatomical
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Basal Ganglia Diseases
 Brain Diseases
Central Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Hypotension
Vascular Diseases
Cardiovascular Diseases