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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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United States, Arizona
Barrow Neurological Institute
Phoenix, Arizona, United States, 80013
United States, California
UC San Diego Department of Neurosciences
La Jolla, California, United States, 92037
UCLA Medical Center / Neurological Services
Los Angeles, California, United States, 90095
Stanford University
Palo Alto, California, United States, 84127
UCSF Memory and Aging Center
San Francisco, California, United States, 95158
United States, Colorado
Rocky Mountain Movement Disorders Center
Englewood, Colorado, United States, 80113
United States, Florida
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States, 33486
University of Florida
Gainesville, Florida, United States, 32611
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
University of South Florida
Tampa, Florida, United States, 33612
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30329
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
University of Chicago
Chicago, Illinois, United States, 60637
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Maryland
John Hopkins University
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Lahey Hospital & Medical Center
Burlington, Massachusetts, United States, 01805
United States, Michigan
QUEST Research Institute
Farmington Hills, Michigan, United States, 48334
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
Albany Medical College
Albany, New York, United States, 12208
NYU School of Medicine, NYU Dysautonomia Center
New York, New York, United States, 10016
Columbia University Medical Center, Neurological Institute
New York, New York, United States, 10032
United States, Pennsylvania
Pennsylvania State University Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Parkinson's Disease and Movement Disorders Center at the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19107
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
Kerwin Research Center
Dallas, Texas, United States, 75231
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98122
Austria
Confraternitaet Privatklinik Josefstadt in Wien
Wien, Vienna, Austria, 1080
University Clinic Innsbruck
Innsbruck, Austria, 06020
France
CHU de Bordeaux, Service de Neurologie
Bordeaux, France, 33076
CHU - Hospital de la Timone
Marseille Cedex 5, France, 13385
Unité d'investigation clinique de Neurologie Rez-de-jardin, Bloc Hopital CHU Pontchaillou
Rennes, France, 35033
Hopitaux Universitaire de Strasbourg-Centre de References des Maladies Autoimmunes
Strasbourg, France, 67098
CHU Purpan
Toulouse cedex 9, France, 31059
Germany
University Hospital of Liepzig
Leipzig, Sachsen, Germany, 04103
St. Josef - Hospital Bochum, Kardiologische Studienambulanz
Bochum, Germany, 44791
Deutsches Zentrum für Neurodegenerative Erkrankungen (DZNE)
Bonn, Germany, 53127
University Hospital Duesseldorf
Dusseldorf, Germany, 40225
CRC Core Facility Medizinische Hochschule Hannover (MHH)
Hannover, Germany, 30625
Paracelsus-Elena-Klinik
Kassel, Germany, 34128
Klinik für Neurologie - UKSH - Campus Kiel
Kiel, Germany, 24105
Universitaetsklinikum Giessen und Marburg GmbH - Parkinson-Studienzentrum, Klinik für Neurologie
Marburg, Germany, 35043
Universitaetsklinikum Muenster
Muenster, Germany, 48149
Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico di Milano
Milano, Milan, Italy, 20122
A.O.U. San Giovanni di Dio e Ruggi d'Aragona
Salerno, Italy, 84100
United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust - Campus for Ageing and Vitality (NGH)
Newcastle Upon Tyne, United Kingdom, NE4 5PL
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
Autonomic Nervous System Diseases
Nervous System Diseases
Central Nervous System Diseases
Pathological Conditions, Anatomical
Primary Dysautonomias
 Basal Ganglia Diseases
Brain Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Hypotension
Vascular Diseases
Cardiovascular Diseases