Study of BHV-3241 in Subjects With Multiple System Atrophy (M-STAR)
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ClinicalTrials.gov Identifier: NCT03952806 |
Recruitment Status :
Completed
First Posted : May 16, 2019
Last Update Posted : January 20, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Multiple System Atrophy | Drug: Verdiperstat Drug: Placebo | Phase 3 |
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 |

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 |
- 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.
- 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.
- 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
- 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.
- 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

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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 |
Inclusion Criteria:
- 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).
- 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.
- Anticipated survival of at least 3 years at the time of Screening, as judged by the Investigator.
Exclusion Criteria:
- 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.
- Diagnosis of neurological disorders, other than MSA.

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

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 |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Multiple System Atrophy (MSA) |
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 |