Study of BHV-3241 in Subjects With Multiple System Atrophy (M-STAR)
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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03952806 |
Recruitment Status :
Recruiting
First Posted : May 16, 2019
Last Update Posted : December 4, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Multiple System Atrophy | Drug: Verdiperstat Drug: Placebo | Phase 3 |
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 |

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 |
- 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).
- 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
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 40 Years to 75 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
Contact: Elyse Stock, MD | 203-404-0410 | clinicaltrials@biohavenpharma.com |

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 |
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 |
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 Neurodegenerative Diseases Hypotension Vascular Diseases Cardiovascular Diseases |