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    Summary
    EudraCT Number:2022-001176-34
    Sponsor's Protocol Code Number:BHV3000-407
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2023-01-12
    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 ConcernedAustria - BASG
    A.2EudraCT number2022-001176-34
    A.3Full title of the trial
    BHV3000-407: A Phase 4, Randomized, Doubleblind, Placebo-controlled Study to Evaluate the Efficacy and Tolerability of Rimegepant for the Prevention of Migraine in Adults with a History of Inadequate Response to Oral Preventive Medications.
    BHV3000-407: Eine randomisierte, doppelblinde, placebokontrollierte Phase-IV-Studie zur Beurteilung der Wirksamkeit und Verträglichkeit von Rimegepant zur Prävention von Migräne bei Erwachsenen mit unzureichendem Ansprechen auf orale Präventivmedikamente in der Vorgeschichte
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Efficacy and Tolerability of Rimegepant for the Prevention of Migraine in Adults with a History of Inadequate Response to other Oral Preventive Medications.
    Eine Studie zur Beurteilung der Wirksamkeit und Verträglichkeit von Rimegepant zur Prävention von Migräne bei Erwachsenen mit unzureichendem Ansprechen auf orale Präventivmedikamente in der Vorgeschichte
    A.4.1Sponsor's protocol code numberBHV3000-407
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05518123
    A.5.4Other Identifiers
    Name:INDNumber:109886
    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 SponsorPfizer 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 supportPfizer Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc.
    B.5.2Functional name of contact pointClinical Trials.gov Call Centre
    B.5.3 Address:
    B.5.3.1Street Address66 Hudson Boulevard East
    B.5.3.2Town/ cityNew York
    B.5.3.3Post code10001
    B.5.3.4CountryUnited States
    B.5.4Telephone number+18007181021
    B.5.6E-mailClinicalTrials.gov_Inquiries@pfizer.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 Yes
    D.2.1.1.1Trade name Vydura
    D.2.1.1.2Name of the Marketing Authorisation holderBiohaven Pharmaceutical Ireland DAC
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameRimegepant sulfate
    D.3.2Product code BHV-3000
    D.3.4Pharmaceutical form Orodispersible 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 INNRimegepant
    D.3.9.1CAS number 1374024-48-2
    D.3.9.2Current sponsor codeBHV-3000
    D.3.9.3Other descriptive nameRimegepant sulfate
    D.3.9.4EV Substance CodeSUB215832
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 placeboOrodispersible 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
    migraine headaches with or without aura
    Migräneanfällen mit oder ohne Aura
    E.1.1.1Medical condition in easily understood language
    accute and episodic migraine with or without aura
    akuten oder episodischen Migräneanfällen mit oder ohne Aura
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10027599
    E.1.2Term Migraine
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of rimegepant to placebo as an EOD dosing regimen for prophylaxis in adults with a history of inadequate response to agents across 2-4 categories of recognized, orally-administered migraine preventive medications as measured by the mean reduction from the Observation Phase in the number of migraine days per month (28 days) over the entire DBT Phase.
    Vergleich der Wirksamkeit von Rimegepant mit Placebo im EOD-Dosierungsschema zur Prophylaxe bei Erwachsenen, die in der gesundheitlichen Vorgeschichte unzureichend auf Wirkstoffe aus 2–4 Kategorien anerkannter, oral verabreichter Medikamente zur Migräneprophylaxe angesprochen haben, gemessen anhand der mittleren Reduktion der Anzahl der Migränetage pro Monat während des gesamten DBT-Abschnitts (28 Tage) gegenüber dem Beobachtungsabschnitt.
    E.2.2Secondary objectives of the trial
    Key Secondary Objectives:
    1. To compare the proportion of subjects with ≥ 50% reduction from the Observation Phase in the number of migraine days of moderate or severe headache pain intensity per month over the entire DBT Phase (Weeks 1 to 12) between rimegepant and placebo.
    2. To compare the mean reduction from the Observation Phase in the number of migraine days per month in the first 4 weeks of the DBT Phase between rimegepant and placebo.
    3. To compare the mean reduction from the Observation Phase in the number of migraine days per month in the last 4 weeks of the DBT Phase between rimegepant and placebo.
    4. To compare the mean change from baseline in the Migraine-Specific Quality-of-Life Questionnaire v 2.1 (MSQ) restrictive role function domain score at Week 12 of the DBT Phase between rimegepant and placebo.
    5. To compare the mean change from baseline in Migraine Interictal Burden Scale (MIBS) score at Week 12 of the DBT Phase between rimegepant and placebo.
    Vergleich (unter Rimegepant und unter placebo):
    1. des Anteils der Studienteilnehmer mit ≥ 50 % Reduktion der Anzahl der Migränetage mit mittelschwerer oder schwerer Kopfschmerzintensität pro Monat während DBT-Abschnitts gegenüber dem Beobachtungsabschnitt.
    2. der mittleren Reduktion der Anzahl der Migränetage pro Monat in den ersten 4 Wochen des DBT-Abschnitts gegenüber dem Beobachtungsabschnitt.
    3. der mittleren Reduktion der Anzahl der Migränetage pro Monat in den letzten 4 Wochen des DBT-Abschnitts gegenüber dem Beobachtungsabschnitt.
    4. der mittleren Veränderung gegenüber dem Ausgangswertim Fragebogen zur migränespezifischen Lebensqualität v 2.1 (Migraine-Specific Quality-of-Life Questionnaire, MSQ) im Bereich der restriktiven Rollenfunktion in Woche 12 des DBT-Abschnitts.
    5. der mittleren Veränderung des Scores auf der Skala der interiktalen Migräne-Belastung (Migraine Interictal Burden Scale, MIBS) in Woche 12 des DBT-Abschnitts gegenüber dem Ausgangswert.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Target Population:
    Minimum 1 year documented history of migraines (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition.3 Per self-report, with confirmation from Investigator / supporting medical record, subjects must have:
    a) Migraine attacks present for more than 1 year from the Screening Visit
    b) Age of onset prior to 50 years of age
    c) Migraine attacks lasting about 4–72 hours, if untreated
    d) 4 to 14 migraine days, on average, across the 3 months prior to the Screening Visit
    e) 4 to 14 migraine days during the 28-day Observation Phase
    f) Subjects must be able to distinguish migraine attacks from tension headaches
    g) Prior inadequate response, within 10 years of the Screening Visit, to agents across 2-4 categories of recognized, orally-administered migraine-preventive medications where at least one example of prior inadequate response is due to lack of efficacy or prior intolerance (not contraindication)
    2) Age and Reproductive Status:
    a) Subjects >=18 years-old
    b) Subject meets reproduction criteria. Refer to section 16.6
    c) At the Baseline Visit, prior to dispensing investigational study drug, WOCBP must have a negative pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) before dosing with study drug.
    E.4Principal exclusion criteria
    1. Target Disease Exclusion
    a) History of cluster headaches, basilar migraine (with aura), or hemiplegic migraine
    b) Current medication overuse headaches
    c) 15 or more headache days (migraine or non-migraine) per month in any of the 3-months prior to the Screening Visit or during the 28-day Observation Phase
    d) 7 or more non-migraine headache days per month, on-average, across the 3-months prior to the Screening Visit or during the 28-day Observation Phase
    e) Inadequate response to agents across > 4 categories of recognized, orally administered, migraine-preventive medications
    2. Medical History and Current Diseases:
    a) History of gastric or small intestinal surgery or disease or conditions that causes malabsorption
    b) BMI ≥ 35kg/m2
    c) Alcohol or drug abuse within the past 12 months or subjects with any significant substance use disorder within the past 12 months from the date of the Screening Visit
    d) Current diagnosis of major depressive disorder requiring treatment with an atypical antipsychotic
    e) Current diagnosis of schizophrenia, bipolar disorder, or borderline personality disorder
    f) Other major psychiatric disorder that might interfere with the ability to properly report clinical outcomes
    g) Major depressive disorder or any anxiety disorder which requires more than 1 daily medication for each disorder.
    h) Major depressive episode within last 12 months prior to the Screening Visit.
    i) Subjects who meet criteria for C-SSRS Suicidal Ideation Items 4 or 5 within the last 12 months prior to the Screening Visit, OR subjects who endorse any of the 5 C-SSRS Suicidal Behavior Items within the last 10 years prior to the Screening Visit, OR subjects who present a serious risk of suicide
    j) Active chronic pain syndromes
    k) Other pain syndromes (including trigeminal neuralgia), dementia, significant neurological disorders other than migraine
    l) Current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease
    m) Myocardial infarction, acute coronary syndrome (ACS), percutaneous coronary intervention (PCI), cardiac surgery, stroke or transient ischemic attack within 6 months prior to the Screening Visit
    n) Uncontrolled hypertension (high blood pressure).
    o) Any unstable medical conditions (e.g., history of congenital heart disease, arrhythmia, or cancer)
    p) Positive drug screen for drugs of abuse that in the Investigator’s judgment is medically significant, in that it would impact the safety of the subject or the interpretation of the study results.
    3. Allergies and Adverse Drug Reactions: History of drug or other allergy which, in the opinion of the investigator, makes the subject unsuitable for participation in the study.
    4. Sex and Reproductive Status:
    a) WOCBP who are unwilling or unable to use required contraception.
    b) Women who are pregnant or breastfeeding
    c) Women with a positive pregnancy test at Screening Visit
    5. ECG and Laboratory Test Findings - as specified in the protocol.
    6. Prohibited Medications and Devices
    a) Recognized migraine-preventive medication taken within 30 days prior the Screening (with exceptions)
    b) Non-Narcotic Analgesics or paracetamol taken 15 days per month during the 3 months prior to the Screening Visit
    c) Any device for migraine prevention or treatment within 3 months prior to the Screening Visit
    d) Ergotamine taken 10 days per month on a regular basis for 3 months in the year prior to the Screening Visit
    e) Narcotic, such as opioid or barbiturate taken for 4 days per month during the 3 months prior to the Screening Visit
    f) Permitted acute migraine medication taken >= 15 days per month for a non-headache indication during the 3 months (12 weeks) prior to the SV
    7. Other:
    a) Non-compliance with or inability to complete eDiary during Observation Phase. Subjects with less than 24 completed eDiary reports during 28 days in the Observation Phase
    b)Exposure to non-biological investigational agents within 30 days prior to the Screening
    c)Exposure to biological investigational agents within 6 months prior to the Screening
    d)Previous enrollment in any multiple dose BHV3000 (rimegepant) study. Subjects may be considered for BHV3000-407 if the subject participated in any of the following single-dose studies: BHV3000-301, BHV3000-302, BHV3000-303, but did not participate in any multiple dose rimegepant study.
    e) Participation in any other clinical study while participating in this clinical study.
    f) Past participation in a clinical study within 30 days prior to the Screening Visit
    g) Failure to complete the Baseline Visit within the timeframe specified in the schedule of assessments
    h)The subject is clinically unsuitable to participate
    i) Site staff directly involved in the conduct of the study and their family, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members
    E.5 End points
    E.5.1Primary end point(s)
    Mean change from the Observation Phase in the number of migraine days per month over the entire double-blind treatment (DBT) Phase.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Weeks 1 to 12.
    E.5.2Secondary end point(s)
    Key Secondary Endpoints
    1.Proportion of subjects with ≥ 50% reduction from the Observation Phase in the number of migraine days of moderate or severe headache pain intensity per month over the entire DBT Phase (Weeks 1 to 12).
    2.Mean change from the Observation Phase in the number of migraine days per month in the first 4 weeks (Weeks 1 to 4) of the DBT Phase.
    3.Mean change from the Observation Phase in the number of migraine days per month in the last 4 weeks (Weeks 9 to 12) of the DBT Phase.
    4.Mean change from baseline in the MSQ restrictive role function domain score at Week 12 of the DBT Phase.
    5.Mean change from baseline in the MIBS score at Week 12 of the DBT Phase.

    Other Secondary Endpoints:
    1.Number and percentage of subjects with AEs by intensity, SAEs, AEs leading to study drug discontinuation, and Grade 3 to 4 laboratory test abnormalities on treatment during the DBT and OLE Phases.
    2.Proportion of subjects with ≥ 50% reduction from the Observation Phase in the number of migraine days (regardless of headache pain intensity) per month over the entire DBT Phase (Weeks 1 to 12).
    3.Mean number of acute migraine-specific medication days per month in each month and over the entire DBT Phase (Weeks 1 to 12).
    4.Mean change from baseline in MIBS scores at Weeks 4, 8, and 12 in the DBT Phase.
    5.Mean change from baseline in the MSQ domain scores (restrictive role function domain, preventive role function domain, and emotional function domain) at Weeks 4, 8, and 12 in the DBT Phase.
    6.Mean change from baseline in the MFIQ scores (Physical Function, Usual Activities, Overall impact on Usual Activities, Social Function, and Emotional Function) in each month of the DBT Phase.
    7.Mean change from baseline in the WPAI – Migraine scores (absenteeism, presenteeism, work productivity loss and activity impairment) at Weeks 4, 8, and 12 in the DBT Phase.
    8.Mean change from baseline in the PGA score in each month of the DBT Phase.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 1 to 12.
    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 No
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    tolerability
    Verträglichkeit
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA76
    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
    Colombia
    Australia
    Canada
    Mexico
    United Kingdom
    United States
    Austria
    Belgium
    Denmark
    Finland
    France
    Germany
    Italy
    Poland
    Spain
    Sweden
    E.8.7Trial has a data monitoring committee No
    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
    the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    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 months3
    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: 570
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state105
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 360
    F.4.2.2In the whole clinical trial 600
    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)
    At the end of the study the sponsor will not continue to supply study drug to subjects or investigators, given that Vydura is already approved in Europe as of April 2022 and other alternatives are currently available for the preventive treatment of episodic migraine. The Investigator should ensure that the subject receives permitted acute migraine standard of care medication to appropriately treat the patient's condition.
    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 Decision2023-01-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-07-11
    P. End of Trial
    P.End of Trial StatusOngoing
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