Study of BHV-3241 in Participants With Multiple System Atrophy
NCT ID: NCT03952806
Last Updated: 2023-09-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
421 participants
INTERVENTIONAL
2019-07-29
2022-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Verdiperstat
Participants received verdiperstat 300 mg tablet orally once daily for 1 week, followed by 300 mg twice daily for 1 week, and then 600 mg twice daily for the remaining 46 weeks of the double-blind phase.
Participants who completed the double-blind phase were offered the opportunity to enroll in an open-label extension (OLE) phase to continue verdiperstat 600 mg twice daily for 48 weeks.
Verdiperstat
300mg 2 oral tablets, twice daily
Placebo
Participants received placebo matching with verdiperstat for 48 weeks. Participants who completed the double-blind phase were offered the opportunity to enroll in an OLE phase to receive verdiperstat 600 mg tablet orally twice daily for 48 weeks.
Placebo
Matching placebo
Interventions
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Verdiperstat
300mg 2 oral tablets, twice daily
Placebo
Matching placebo
Eligibility Criteria
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Inclusion Criteria
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
2. Diagnosis of neurological disorders, other than MSA.
40 Years
80 Years
ALL
No
Sponsors
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Biohaven Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Barrow Neurological Institute
Phoenix, Arizona, United States
UC San Diego Department of Neurosciences
La Jolla, California, United States
UCLA Medical Center / Neurological Services
Los Angeles, California, United States
Stanford University
Palo Alto, California, United States
UCSF Memory and Aging Center
San Francisco, California, United States
Rocky Mountain Movement Disorders Center
Englewood, Colorado, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States
University of Florida
Gainesville, Florida, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
University of South Florida
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
John Hopkins University
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Lahey Hospital & Medical Center
Burlington, Massachusetts, United States
QUEST Research Institute
Farmington Hills, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Albany Medical College
Albany, New York, United States
NYU School of Medicine, NYU Dysautonomia Center
New York, New York, United States
Columbia University Medical Center, Neurological Institute
New York, New York, United States
Pennsylvania State University Hershey Medical Center
Hershey, Pennsylvania, United States
Parkinson's Disease and Movement Disorders Center at the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Kerwin Research Center
Dallas, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Swedish Medical Center
Seattle, Washington, United States
Confraternitaet Privatklinik Josefstadt in Wien
Vienna, Vienna, Austria
University Clinic Innsbruck
Innsbruck, , Austria
CHU de Bordeaux, Service de Neurologie
Bordeaux, , France
CHU - Hospital de la Timone
Marseille, , France
Unité d'investigation clinique de Neurologie Rez-de-jardin, Bloc Hopital CHU Pontchaillou
Rennes, , France
Hopitaux Universitaire de Strasbourg-Centre de References des Maladies Autoimmunes
Strasbourg, , France
CHU Purpan
Toulouse, , France
University Hospital of Liepzig
Leipzig, Saxony, Germany
St. Josef - Hospital Bochum, Kardiologische Studienambulanz
Bochum, , Germany
Deutsches Zentrum für Neurodegenerative Erkrankungen (DZNE)
Bonn, , Germany
University Hospital Duesseldorf
Düsseldorf, , Germany
CRC Core Facility Medizinische Hochschule Hannover (MHH)
Hanover, , Germany
Paracelsus-Elena-Klinik
Kassel, , Germany
Klinik für Neurologie - UKSH - Campus Kiel
Kiel, , Germany
Universitaetsklinikum Giessen und Marburg GmbH - Parkinson-Studienzentrum, Klinik für Neurologie
Marburg, , Germany
Universitaetsklinikum Muenster
Münster, , Germany
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico di Milano
Milan, Milan, Italy
A.O.U. San Giovanni di Dio e Ruggi d'Aragona
Salerno, , Italy
The Newcastle upon Tyne Hospitals NHS Foundation Trust - Campus for Ageing and Vitality (NGH)
Newcastle upon Tyne, , United Kingdom
Countries
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References
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Schmahmann JD, Pierce S, MacMore J, L'Italien GJ. Development and Validation of a Patient-Reported Outcome Measure of Ataxia. Mov Disord. 2021 Oct;36(10):2367-2377. doi: 10.1002/mds.28670. Epub 2021 Jun 11.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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BHV3241-301
Identifier Type: -
Identifier Source: org_study_id
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