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

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ClinicalTrials.gov Identifier: NCT03952806
Recruitment Status : Recruiting
First Posted : May 16, 2019
Last Update Posted : December 4, 2019
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)
Estimated Enrollment : 250 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
Actual Study Start Date : July 29, 2019
Estimated Primary Completion Date : October 20, 2021
Estimated Study Completion Date : October 20, 2021

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. Efficacy of BHV-3241, compared to placebo, as measured by a change from baseline in the Unified MSA Rating Scale (UMSARS) Part I and II total score at Week 48. [ Time Frame: Change from Baseline to Week 48 ]
    The UMSARS is a scale for the assessment of subjects with MSA. Part I, Historical Review, is an assessment of functioning across various areas (12 items). Part II is a Motor Examination (14 items).


Secondary Outcome Measures :
  1. Efficacy of BHV-3241,compared to placebo, as measured by the Clinical Global Impression of Change (CGI-C) score at Week 48. [ Time Frame: Change from Baseline Week 48 ]
    measure of clinician rated improvement

  2. Impact of BHV-3241 on quality of life, relative to placebo, as measured by a change from baseline in the MSA-Quality of Life (MSA-QoL) scale at Week 48. [ Time Frame: Change from Baseline to Week 48 ]
    measure the quality of life perceived by patient


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 75 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


Contacts
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Contact: Elyse Stock, MD 203-404-0410 clinicaltrials@biohavenpharma.com

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Locations
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United States, Arizona
Barrow Neurological Institute Recruiting
Phoenix, Arizona, United States, 80013
Contact: Jade Stohl    602-406-3719    jade.stohl@DignityHealth.org   
United States, California
UC San Diego Department of Neurosciences Recruiting
La Jolla, California, United States, 92037
Contact: Rachel Schade    858-246-2533    rschade@ucsd.edu   
UCLA Medical Center / Neurological Services Recruiting
Los Angeles, California, United States, 90095
Contact: Natalie Skigen    310-206-8153    NSkigen@mednet.ucla.edu   
Stanford University Recruiting
Palo Alto, California, United States, 84127
Contact: Jordan Seliger    650-460-9260    JSeliger@stanford.edu   
UCSF Memory and Aging Center Recruiting
San Francisco, California, United States, 95158
Contact: Julia Glueck    415-502-7640    Julia.Glueck@ucsf.edu   
United States, Colorado
Rocky Mountain Movement Disorders Center Recruiting
Englewood, Colorado, United States, 80113
Contact: Scott Rubinstein    303-357-5447    srubinstein@kumarneuro.com   
United States, Florida
Parkinson's Disease and Movement Disorders Center of Boca Raton Recruiting
Boca Raton, Florida, United States, 33486
Contact: Jocelyne Fimiano    561-392-1818 ext 6    jfimiano@parkinsonscenter.org   
University of Florida Recruiting
Gainesville, Florida, United States, 32611
Contact: Derek Ridgeway    352-273-5612    Derek.Ridgeway@neurology.ufl.edu   
Mayo Clinic Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Audrey Strongosky    904-953-8308    strongosky.audrey@mayo.edu   
University of South Florida Recruiting
Tampa, Florida, United States, 33612
Contact: Magee McGriff    813-974-1414    mmcgriff@health.usf.edu   
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30329
Contact: Jonna Seppa    404-727-1509    jseppa@emory.edu   
United States, Illinois
Rush University Medical Center Not yet recruiting
Chicago, Illinois, United States, 60612
Contact: Jacob Hawkins    312-563-2900 ext Press 4/ Code:    Movement_Disorder@rush.edu   
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Lani Leong    773-834-1688    lani@neurology.bsd.uchicago.edu   
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Lindsey Hartke    913-588-5238    lhartke@kumc.edu   
United States, Maryland
John Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Kori Ribb, BSN, RN    410-614-2216    klough2@jhmi.edu   
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Brigitte Jacoby    617-726-4961    Bjacoby@mgh.harvard.edu   
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Sharika Rajan    617-632-8964    srajan@bidmc.harvard.edu   
Lahey Hospital & Medical Center Recruiting
Burlington, Massachusetts, United States, 01805
Contact: LeeAnne Lipert    781-744-2862    leeanne.lipert@lahey.org   
United States, Michigan
QUEST Research Institute Recruiting
Farmington Hills, Michigan, United States, 48334
Contact: Ashley Murphy    248-957-8940    ashley@questri.com   
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Kristine Severson    507-422-5314    severson.kristine@mayo.edu   
United States, New York
Albany Medical College Recruiting
Albany, New York, United States, 12208
Contact: Sharon Evans    518-262-6682    evanss@amc.edu   
NYU School of Medicine, NYU Dysautonomia Center Recruiting
New York, New York, United States, 10016
Contact: Jose Martinez    212-263-7225    Jose.Martinez4@nyulangone.org   
Columbia University Medical Center, Neurological Institute Recruiting
New York, New York, United States, 10032
Contact: Nadia Amokrane    212-305-7963    na2855@cumc.columbia.edu   
United States, Pennsylvania
Pennsylvania State University Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Tyler Corson    717-531-0003 ext 281168    tcorson@pennstatehealth.psu.edu   
Parkinson's Disease and Movement Disorders Center at the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Marcela Pavon    215-829-7725    Marcela.Pavon@uphs.upenn.edu   
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Rene Holly    615-343-6499    rene.holly@vumc.org   
United States, Texas
Kerwin Research Center Recruiting
Dallas, Texas, United States, 75231
Contact: Sarah Sutton    214-345-1239    SarahSutton@kerwinresearchcenter.com   
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Steve Hopkins    214-648-9275    steve.hopkins@utsouthwestern.edu   
United States, Washington
Swedish Medical Center Recruiting
Seattle, Washington, United States, 98122
Contact: Jennifer Cardey    206-320-3695    Jennifer.Cardey@Swedish.org   
Austria
Confraternitaet Privatklinik Josefstadt in Wien Not yet recruiting
Wien, Vienna, Austria, 1080
Contact: Ursula Panzenbock    00 43 200200 68    u.panzenboeck@dzu.at   
University Clinic Innsbruck Not yet recruiting
Innsbruck, Austria, 06020
Contact: Katarzyna Wachowicz    0043 512 504 25810    Katarzyna.Wachowicz@tirol-kliniken.at   
France
CHU de Bordeaux, Service de Neurologie Not yet recruiting
Bordeaux, France, 33076
Contact: Sandrine Dupouy    00 33 5 57 82 14 62    sandrine.dupouy@chu-bordeaux.fr   
CHU - Hospital de la Timone Not yet recruiting
Marseille cedex 5, France, 13385
Contact: Nouira Manel    00 33 4 91 43 54 70    Manel.NOUIRA@ap-hm.fr   
Unité d'investigation clinique de Neurologie Rez-de-jardin, Bloc Hopital CHU Pontchaillou Not yet recruiting
Rennes, France, 35033
Contact: Francoise Kestens    00 33 2 99 28 93 34    francoise.kestens@chu-rennes.fr   
Hopitaux Universitaire de Strasbourg-Centre de References des Maladies Autoimmunes Not yet recruiting
Strasbourg, France, 67098
Contact: Fanny Huselstein       fanny.huselstein@chru-strasbourg.fr   
CHU Purpan Not yet recruiting
Toulouse cedex 9, France, 31059
Contact: Pascale Gauteul    00 33 5 61 77 91 14    Pascale.gauteul@inserm.fr   
Germany
University Hospital of Liepzig Not yet recruiting
Leipzig, Sachsen, Germany, 04103
Contact: Andrea Kalb    00 49 3 49 72 43 20    Andrea.Kalb@medizin.uni-leipzig.de   
St. Josef - Hospital Bochum, Kardiologische Studienambulanz Not yet recruiting
Bochum, Germany, 44791
Contact: Daniela Kaminski    00 49 23 4509 2703    d.kaminski@klinikum-bochum.de   
Deutsches Zentrum für Neurodegenerative Erkrankungen (DZNE) Not yet recruiting
Bonn, Germany, 53127
Contact: Bianca Jacobs    00 49 228 4330 2813    bianca.jacobs@dzne.de   
University Hospital Duesseldorf Not yet recruiting
Dusseldorf, Germany, 40225
Contact: Tugce Goeksel-Aciksoez    0049 02 11811 8075    Tugce.Goeksel-Aciksoez@med.uni-duesseldorf.de   
CRC Core Facility Medizinische Hochschule Hannover (MHH) Not yet recruiting
Hannover, Germany, 30625
Contact: Marion Quindel       quindel.marion@mh-hannover.de   
Paracelsus-Elena-Klinik Not yet recruiting
Kassel, Germany, 34128
Contact: Grit Langhans    00 49 561 600 9169    grit.langhans@pkd.de   
Klinik für Neurologie - UKSH - Campus Kiel Not yet recruiting
Kiel, Germany, 24105
Contact: Birte Hackelberg    00 43 1 50 02 39 89    birte.hackelberg@uksh.de   
Universitaetsklinikum Giessen und Marburg GmbH - Epilepsiezentrum Marburg (EZM) Not yet recruiting
Marburg, Germany, 35039
Contact: Silvia Jung    00 49 06421 58 65439    jungsi@med.uni-marburg.de   
LMU - Klinikum der Universitaet Muenchen - Campus Grosshadern Not yet recruiting
Muenchen, Germany, 81377
Contact: Johannes Levin    49 894 4007 6695    johannes.levin@med.uni-muenchen.de   
Universitaetsklinikum Muenster Not yet recruiting
Muenster, Germany, 48149
Contact: Anna-Lena Schwake    00 49 251 834 6081    Anna-lena.Schwake@ukmuenster.de   
Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico di Milano Not yet recruiting
Milano, Milan, Italy, 20122
Contact: Giulia Lazzeri    39 025 503 3807    giulia.lazzeri@outlook.com   
Azienda Univesrita' Ospedale, Clinica Neurologica Not yet recruiting
Padova, Italy, 35127
Contact: Valentina Misenti    39 049 821 4400    valentina.misenti@unipd.it   
A.O.U. San Giovanni di Dio e Ruggi d'Aragona Not yet recruiting
Salerno, Italy, 84100
Contact: Maria Teresa Pellecchia    39 089 673703    mpellecchia@unisa.it   
United Kingdom
The National Hospital for Neurology and Neurosurgery Not yet recruiting
London, United Kingdom, WC1N 3BG
Contact: Joshua Elflein    020 3448 4544    joshua.elflein@ucl.ac.uk   
The Newcastle upon Tyne Hospitals NHS Foundation Trust - Campus for Ageing and Vitality (NGH) Not yet recruiting
Newcastle Upon Tyne, United Kingdom, NE4 5PL
Contact: Alison Sutherland       alison.sutherland@newcastle.ac.uk   
Nuffield Oxford University and Oxford University Hospital NHS Foundation Trusts-John Radcliffe Hospital Not yet recruiting
Oxford, United Kingdom, OX3 9DU
Contact: Emmanuel Debrah    01865 231556    Emmanuel.debrah@ouh.nhs.uk   
Royal Gwent Hospital Not yet recruiting
Wales, United Kingdom, CF24 4HQ
Contact: Andy Davidson    44 (0)29 2087 0717    davisona5@cardiff.ac.uk   
Sponsors and Collaborators
Biohaven Pharmaceuticals, Inc.
More Information
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Responsible Party: Biohaven Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03952806     History of Changes
Other Study ID Numbers: BHV3241-301
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: December 4, 2019
Last Verified: December 2019

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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
Neurodegenerative Diseases
Hypotension
Vascular Diseases
Cardiovascular Diseases