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    Summary
    EudraCT Number:2019-001100-38
    Sponsor's Protocol Code Number:BHV3241-301
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-10-07
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2019-001100-38
    A.3Full title of the trial
    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)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess whether a drug called BHV-3241 works and is safe to use in people with Multiple System Atrophy (M-STAR Study)
    A.4.1Sponsor's protocol code numberBHV3241-301
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03952806
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBiohaven Pharmaceuticals, Inc
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBiohaven Pharmaceuticals, Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiohaven Pharmaceuticals Inc
    B.5.2Functional name of contact pointMedical Information
    B.5.3 Address:
    B.5.3.1Street Address215 Church Street
    B.5.3.2Town/ cityNew haven, CT
    B.5.3.3Post code06510
    B.5.3.4CountryUnited States
    B.5.4Telephone number+12034040410
    B.5.5Fax number+12032444239
    B.5.6E-mailmedinfo@biohavenpharma.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/14/1404
    D.3 Description of the IMP
    D.3.1Product nameBHV-3241
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVerdiperstat
    D.3.9.2Current sponsor codeBHV-3241
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Multiple System Atrophy
    E.1.1.1Medical condition in easily understood language
    A progressive neurodegenerative disorder that affects the involuntary nervous system and movement.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10064060
    E.1.2Term Multiple system atrophy
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To evaluate the efficacy of BHV-3241, compared to placebo, as measured by a change from baseline in a modified Unified MSA Rating Scale (UMSARS), consisting of a subset of items from Part I and Part II, at Week 48.
    • To assess the safety and tolerability of BHV-3241, relative to placebo, in subjects with MSA.
    E.2.2Secondary objectives of the trial
    Key Secondary
    • To evaluate the efficacy of BHV-3241, compared to placebo, as
    measured by the Clinical Global Impression of Improvement (CGI-I)
    score at Week 48
    •To evaluate the impact of BHV-3241 on quality of life, compared to
    placebo, as measured by a change from baseline in the motor subscale
    of the MSA-Quality of Life (MSA-QoL) scale at Week 48
    • To evaluate the impact of BHV-3241 on quality of life, compared to
    placebo, as measured by a change from baseline in the non-motor
    subscale of the MSA- QoL scale at Week 48.
    •To 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.
    Other Secondary
    • To assess the impact of BHV-3241, relative to placebo, as measured by
    a change from baseline at Week 48 in the following instruments:
    - Patient Global Impression of Severity (PGI-S),
    - Clinical Global Impression of Severity (CGI-S),
    - UMSARS Part III
    - UMSARS Part IV
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Title:Optional Cerebrospinal fluid (CFS) sub-study
    Objective: To evaluate BHV-3241 PK concentrations and PD biomarkers in
    the CSF at Baseline and second at Week 48 or early withdrawal.

    Potential Exploratory CSF analytes may include concentrations of BHV-3241 and neurofilament light chain (NfL).

    E.3Principal inclusion criteria
    Informed Consent
    a. Subjects must provide a written signed and dated informed consent
    form/forms (IRB/EC specific)in accordance with regulatory and
    institutional guidelines prior to the initiation of any protocol required
    procedures. Only patients with the capacity to understand the nature ,
    significance, and scope of the clinical trial interventions and to express
    their wishes accordingly may provide consent to participate in the study.
    b. Caregivers must be willing to sign and date an IRB/EC-approved
    written informed consent form that outlines the caregiver expectations
    and responsibilities in this study in accordance with regulatory and
    institutional guidelines, as appropriate.
    Age and Sex
    a. Male and female subjects between the ages of > or = 40 to = or <80
    years at time of Screening.
    Target Population
    a. Diagnosis of probable or possible MSA according to consensus clinical
    criteria including subjects with MSA of either subtype (MSA-P or MSA-
    C).
    b. Able to ambulate without the assistance of another person, defined as
    the ability to take at least 10 steps. Use of assistive devices is allowed.
    c. Anticipated survival of at least 3 years at the time of Screening, as
    judged by the Investigator.
    d. A brain MRI scan (conducted within the 14 days prior to Baseline/Day
    1, approximately) that does not rule out a diagnosis of MSA.
    e. Able to tolerate MRI.
    f. Body mass index (BMI) = or < 40 kg/m2at Screening.
    g. Able to swallow tablets whole and anticipated to be able to do so
    throughout the duration of the study.
    h. Willing and able to adhere to the study drug regimen.
    i. Willing and able to perform all protocol-specified assessments and
    comply with the study visit schedule.
    j. Able to read, understand, and speak local language fluently to ensure
    comprehension of informed consent and protocol-specified assessments.
    k. Must have reliable caregiver to accompany subject to study visits.
    With the same Caregiver giving caregiver completing assessments at
    Baseline, Week 24 and Week 48/ Early discontinuation, when possible.
    Caregiver must be able to read, understand, and speak local language
    fluently to ensure comprehension of informed consent and protocol-
    specified assessments. Caregiver must also have frequent contact with
    subject (at least 3 hours per week at one time or different times) and be
    willing to monitor the subject's health and concomitant medications
    throughout the study.
    l. If subject is receiving treatment for MSA, the doses must have been
    stable for at least 30 days prior to Baseline/Randomization and
    medication present at Baseline. expected to remain relatively stable during the study period. This may include medications commonly used
    for Parkinson's disease or those for autonomic dysfunction.
    m. Stable on other chronic medications and supplements for at least 30
    days prior to Baseline/Randomization and expected to remain relatively
    stable during the study period..
    n. Women of child bearing potential (WOCBP) and fertile men (including
    those vasectomized for less than 6 months) with female partners who
    are WOCBP (not surgically sterile and not post-menopausal) must agree
    to use highly effective birth control, including two methods of
    contraception, for the duration of the study (beginning 30 days prior to
    Baseline/Randomization and extending to 30 days for women and 90
    days for men after the last dose of study drug). The two methods of
    contraception should include:
    - one barrier method (e.g. diaphragm with spermicide, condom with
    spermicidal gel, cervical cap);
    - and one other method that could include hormonal contraceptives (e.g.
    oral contraceptives, injectable contraceptives, contraceptive implant,
    patch) used for at least 4 weeks prior to sexual intercourse.
    o. WOCBP must have a negative serum pregnancy test at Screening and
    a negative urine pregnancy test within approximately 24 hours prior to
    dosing at Baseline/Randomization.

    E.4Principal exclusion criteria
    Target Disease Exceptions
    a. Subjects having advanced disease as defined in the protocol.
    b. Subjects having significant cognitive impairment, defined by a score of
    less than or equal to 20 on the MoCA
    Medical History Exclusions
    a. 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.
    b. Diagnosis of neurological disorders, other than MSA as defined in the
    protocol
    c. History of or Screening brain MRI scan indicative of significant
    abnormality.
    d. Contraindication to MRI examination for any reason.
    e. For optional CSF sub-study: contraindication to undergoing an LP.
    f. Presence of clinically significant thyroid disease with abnormal free T4
    levels and TSH >10mIU/L (despite treatment) at Screening , confirmed
    by repeat.
    g. Within 1 year prior to Screening or between Screening and Baseline
    (Day -1), any of the following: myocardial infarction; hospitalization for
    congestive heart failure; hospitalization for, or symptoms of, unstable
    angina; or syncope not related to MSA.
    h. Diagnosis of clinically significant psychiatric disorder as defined in the
    protocol.
    i. History of substance use disorder (drug or alcohol) in the last 12
    months, with
    the exception of nicotine, as defined by DSM-V criteria.
    j. History or presence of gastrointestinal or other disease known to
    interfere with absorption, distribution, metabolism, or excretion of
    drugs, or a history of surgery known to interfere with absorption or
    excretion of drugs (i.e. gastric bypass).
    k. History of any other clinically significant disease that, based on the
    judgment of the Investigator, is clinically unstable, is likely to
    deteriorate during the course of the study, could put the patient at risk
    because of participation in the study, could affect the subject's ability to
    complete the study, or could influence the study results.
    l. History of human immunodeficiency virus infection.
    m. Hematologic or solid malignancy diagnosis within 5 years prior to
    Screening.
    n. Any major surgery within 4 weeks of Screening.
    o. Blood transfusion within 4 weeks of Screening.
    p. History of brain surgery for Parkinsonism.
    q. History of stem-cell treatment.
    r. Women who are pregnant or breastfeeding.
    s. Subjects or prisoners who are involuntarily detained or incarcerated
    for treatment of either a psychiatric or physical illness must not be
    enrolled into the study.
    t. Any medical condition, based on the judgement of the Investigator,
    that would confound the ability to adequately assess safety and efficacy
    outcome measures
    Physical and Laboratory Test Findings
    a. Evidence of organ dysfunction or any clinically significant deviation
    from normal in physical examination, vital signs, ECG, or clinical
    laboratory determinations beyond what is consistent with the target
    population.
    b. Clinically significant abnormality on 12-lead ECG prior to study drug
    administration beyond what is consistent with the target population,
    confirmed by repeat.
    c. QTcF (Fridericia) interval ≥ 470 msec during the Screening/Baseline
    period or uncontrolled arrhythmia or frequent premature ventricular
    contraction (PVCs) (> 5/minute) or Mobitz Type II second or third
    degree atrioventricular (AV) block or left bundle branch block, or right
    bundle branch block with a QRS
    duration ≥ 150 msec or intraventricular conduction defect with a QRS
    duration ≥ 150 msec or evidence of acute or sub-acute myocardial
    infarction or ischemia or other ECG findings that, in the Investigator's
    opinion, would preclude participation in the study.
    d. Abnormal free T4 levels and TSH >10mIU/L (despite treatment) at
    Screening, confirmed by repeat.
    e. Total bilirubin, alanine aminotransferase (ALT) or aspartate
    aminotransferase (AST) greater than 2 times the upper limit of normal
    (ULN), confirmed by repeat. If the patient has Gilbert's Syndrome, the
    patient can be discussed with the Medical Monitor.
    f. Pathologic renal findings at Screening as defined in the protocol.
    g. Hematologic abnormalities at Screening as defined in the protocol.
    h. Hemoglobin A1C = or >7.5%, confirmed by repeat.
    i. Urine drug screen positive for a drug of abuse, for which the patient
    does not have a valid prescription and is suspected of abusing, in the
    judgement of the investigator.
    j. Human Immunodeficiency Virus (HIV) positive at Screening (indicated
    by positive confirmatory Western Blot).
    k. HBsAg or HCV positive at Screening.
    l. For WOCBP, positive serum β-hCG which is indicative of pregnancy and
    not false positive at screening or positive urine test at Baseline

    E.5 End points
    E.5.1Primary end point(s)
    • Change from baseline in a modified UMSARS score, based on a subset
    of items from Part I and II, at Week 48.
    • The frequency of unique subjects with: serious adverse events;
    adverse events leading to discontinuation; adverse events judged to be
    related to study medication; clinically significant ECG abnormalities and
    clinically significant laboratory abnormalities.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Efficacy:
    Unified MSA Rating Scale (UMSARS) Parts I-II - Screening, Baseline, Wks 4, 12, 24, 36, 48 or early discontinuation or from week 48-60 due to covid delays

    Safety:
    Physical Examination; Vital Signs; Sheehan Suicidality Tracking Scale -
    Screening, Baseline, Wks 2, 4, 12, 24, 36, 48 or Early Discontinuation or from week 48-60 due to covid delays.
    Physical Measurements - Screening, Baseline, Wk48 or Early Discontinuation or from week 48-60 due to covid delays.
    ECG (12-lead); Laboratory Tests; Pregnancy Test - Screening, Baseline,
    Wk 4, 12, 24, 36, 48 or Early Discontinuation or from week 48-60 due to covid delays.
    SAE/AEs - throughout the study
    E.5.2Secondary end point(s)
    Key Secondary
    • The CGI-I score at Week 48.
    • Change from Baseline in MSA-QoL motor subscale at Week 48.
    • Change from Baseline in the non-motor subscale at Week 48.
    • Change from Baseline UMSARS Part I and II total at Week 48.
    Other Secondary
    • Change from baseline at Week 48 on the following instruments:
    - PGI-S,
    - CGI-S,
    - UMSARS Part III,
    - UMSARS Part IV.
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Clinical Global Impression of Improvement (CGI-I)- Wks 4, 12, 24, 36, 48 or Early Discontinuation or from week 48-60 due to covid delays.
    • MSA QoL at Baseline and Weeks 24 and 48 or Early Discontinuation or from week 48-60 due to covid delays
    • UMSARS (Part I - IV) - Screening, Baseline, Wks 4, 12, 24, 36, 48 or early discontinuation or from week 48-60 due to covid delays
    • Patient Global Impression of Severity (PGI-S) - Baseline, Wks 4, 12, 24, 36, 48 or Early Discontinuation or from week 48-60 due to covid delays
    • Clinical Global Impression of Severity (CGI-S) - Baseline, Wks 4, 12, 24, 36, 48 or Early Discontinuation or from week 48-60 due to covid delays
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA19
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    China
    France
    Germany
    Italy
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 211
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 211
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state53
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 144
    F.4.2.2In the whole clinical trial 422
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Eligible subjects will have the opportunity to continue in a 48 week open label extension phase (once it is open for recruitment at their study site)
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-01-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-06-30
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