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    Summary
    EudraCT Number:2021-005239-22
    Sponsor's Protocol Code Number:BHV3000-404
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-09-06
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2021-005239-22
    A.3Full title of the trial
    A Phase 4 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rimegepant in Episodic Migraine Prevention with Multiple Dosing Regimens
    Studio di Fase 4, randomizzato, in doppio cieco, controllato con placebo volto a valutare l’efficacia e la sicurezza di rimegepant nella prevenzione dell’emicrania episodica con regimi di dosaggio multipli
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Evaluate the Efficacy and Safety of Rimegepant in Episodic Migraine Prevention, in Adults.
    Studio per valutare l’efficacia e la sicurezza di rimegepant nella prevenzione dell’emicrania episodica negli adulti
    A.3.2Name or abbreviated title of the trial where available
    BHV3000-404
    BHV3000-404
    A.4.1Sponsor's protocol code numberBHV3000-404
    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 Holding Company Limited
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiohaven Pharmaceuticals Holding Company Limited
    B.5.2Functional name of contact pointJeremy Cordova
    B.5.3 Address:
    B.5.3.1Street Address215 Church Street, New Haven
    B.5.3.2Town/ cityConnecticut
    B.5.3.3Post code06510
    B.5.3.4CountryUnited States
    B.5.6E-mailjeremy.cordova@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 Yes
    D.2.1.1.1Trade name Vydura
    D.2.1.1.2Name of the Marketing Authorisation holderBiohaven Pharmaceutical Ireland DAC
    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 75mg
    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.3.9.2Current sponsor codeBHV3000
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Acute Migraine (with or without aura)
    Emicrania acuta (con o senza aura)
    E.1.1.1Medical condition in easily understood language
    Migraine
    Emicrania
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of EOD and daily rimegepant dosing regimens relative to placebo as a preventive treatment for episodic migraine, as measured by the mean reduction from the Observation Phase in the number of migraine days per month over the entire Double-blind Treatment Phase.
    Valutare l’efficacia dei regimi di dosaggio EOD e giornalieri di rimegepant rispetto al placebo come trattamento preventivo per l’emicrania episodica, misurata in base alla riduzione media dalla Fase di osservazione nel numero di giorni di emicrania al mese nell’intera Fase di trattamento in doppio cieco.
    E.2.2Secondary objectives of the trial
    1. To evaluate the proportion of subjects with = 50% reduction in the number of moderate to severe migraine days per month
    2. To evaluate the mean reduction in the number of migraine days per month in the last 4 weeks
    3. To evaluate the mean reduction in the number of migraine days per month in the first 4 weeks
    4. To evaluate the mean number of acute migraine-specific medication days per month
    5. To evaluate the mean change from baseline in the Migraine-Specific Quality-of-Life Questionnaire restrictive role function domain score
    6. To evaluate the safety and tolerability of rimegepant
    7. To evaluate the frequency of ALT or AST > 3x upper limit of normal concurrent with total bilirubin > 2x ULN in subjects treated with
    rimegepant
    8. To evaluate the frequencies of hepatic-related adverse events (AEs) and hepatic-related AEs leading to study drug discontinuation in subjects
    treated with rimegepant
    1. Valutare la % di soggetti con riduzione di = 50% nel numero di giorni al mese di emicrania da moderata a grave
    2. Valutare la riduzione media nel numero di giorni di emicrania al mese nelle ultime 4 settimane
    3. Valutare la riduzione media nel numero di giorni di emicrania al mese nelle prime 4 settimane
    4. Valutare il numero medio di giorni al mese di farmaci sintomatici specifici per l’emicrania
    5. Valutare la variazione media rispetto al basale nel punteggio del dominio della funzione funzionale del ruolo restrittivo del Questionario sulla qualità della vita specifico per l’emicrania
    6. Valutare la sicurezza e la tollerabilità di rimegepant
    7. Valutare la frequenza di ALT o AST > 3 volte l'ULN concomitante con bilirubina totale > 2 volte l’ULN in soggetti trattati con rimegepant
    8. Valutare le frequenze degli eventi avversi (AE) epatici e degli AE epatici che portano all’interruzione del farmaco dello studio nei soggetti trattati con rimegepant
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Target Population = Subject has at least 1 year history of episodic migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition, including the following:
    a) Age of onset of migraines prior to 50 years of age
    b) Migraine attacks, on average, lasting 4-72 hours if untreated
    c) Per subject report, 4-14 migraine attacks per month within the last 3 months prior to the Screening Visit (month is defined as 4 weeks for the purpose of this protocol)

    2) Male and female subjects = 18 years
    1) Popolazione target = soggetto con almeno un anno di anamnesi di emicrania episodica (con o senza aura) coerente con una diagnosi secondo la Classificazione internazionale dei disturbi di cefalea (International Classification of Headache Disorders), 3a edizione, incluso quanto segue:
    a) insorgenza di emicrania prima dei 50 anni
    b)attacchi di emicrania che durano 4-72 ore se non trattati
    c) Secondo la propria segnalazione, 4-14 attacchi di emicrania al mese negli ultimi 3 mesi precedenti la visita di screening (il mese è definito come 4 settimane ai fini di questo protocollo)

    2) Soggetti di sesso maschile e femminile, di età pari o superiore a 18 anni
    E.4Principal exclusion criteria
    1) Medical History and Concurrent Diseases:
    a) Subject history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Subjects with myocardial infarction (MI), acute coronary syndrome (ACS), percutaneous coronary intervention (PCI), cardiac surgery, stroke or transient ischemic attack (TIA) during the 6 months (24 weeks) prior to the Screening Visit,
    b) Uncontrolled hypertension (high blood pressure) or uncontrolled diabetes,
    c) The subject has a history or current evidence of any unstable medical conditions (e.g., history of congenital heart disease or arrhythmia, known or suspected infection, hepatitis B or C, or cancer) that, in the investigator’s opinion, would expose them to undue risk of a significant adverse event (AE) or interfere with assessments of safety or efficacy during the course of the study,
    d) History of use of narcotics, such as opioids (e.g. morphine, codeine, oxycodone, hydrocodone) or barbiturates (e.g. butalbital) for = 4 days per month during the 3 months (12 weeks) prior to the Screening Visit.

    2) Sex and Reproductive Status :
    a) WOCBP who are unwilling or unable to use an acceptable contraceptive method or abstinence to avoid pregnancy for the entire study and for 60 days after the last dose of study drug,
    b) Women who are pregnant or breastfeeding,
    c) Women with a positive pregnancy test at screening or prior to study drug administration.

    3) Prohibited Medications:
    a) Medication for migraine prophylaxis generally considered to have efficacy, regardless of indication, taken within 30 days prior the Screening Visit.
    b) Analgesics (e.g., nonsteroidal anti-inflammatory drugs [NSAIDs] or acetaminophen) taken = 15 days per month during the 3 months (12 weeks) prior to the Screening Visit.
    c) Medication accepted for treatment of acute migraine for a non-migraine indication taken = 15 days per month during the 3 months (12 weeks) prior to the Screening Visit.
    d) Biologic migraine medication (such as CGRP monoclonal antibodies) taken during the 6 months (24 weeks) prior to the Screening Visit.
    e) Prohibited medication or device used during the Observation Phase.
    1) Anamnesi medica e malattie concomitanti:
    a) Anamnesi del soggetto con evidenza attuale di malattie cardiovascolari non controllate, instabili o recentemente diagnosticate, come cardiopatia ischemica, vasospasmo coronarico e ischemia cerebrale. Soggetti con infarto miocardico, sindrome coronarica acuta , intervento coronarico percutaneo, chirurgia cardiaca, ictus o attacco ischemico transitorio nei 6 mesi (24 settimane) precedenti la visita di screening,
    b) Ipertensione non controllata (pressione alta) o diabete non controllato,
    c) Anamnesi o evidenza attuale di condizioni mediche instabili (per esempio, anamnesi di cardiopatia congenita o aritmia, infezione nota o sospetta, epatite B o C, o cancro) che, a giudizio dello sperimentatore, esporrebbero il soggetto a un rischio eccessivo di un evento avverso significativo (AE) o interferirebbero con le valutazioni di sicurezza o efficacia nel corso dello studio,
    d) Anamnesi di uso di narcotici, come oppioidi (es. morfina, codeina, ossicodone, idrocodone) o barbiturici (es. butalbital) per = 4 giorni al mese nei 3 mesi (12 settimane) precedenti la visita di screening.

    2) Sesso e stato riproduttivo:
    a) Donne che non vogliono o non possono usare un metodo contraccettivo accettabile o l'astinenza per evitare la gravidanza per tutta la durata dello studio e per 60 giorni dopo l'ultima dose di farmaco in studio,
    b) Donne in gravidanza o in fase di allattamento,
    c) donne con un test di gravidanza positivo allo screening o prima della somministrazione del farmaco in studio.

    3) Farmaci vietati:
    a) Farmaci per la profilassi dell'emicrania generalmente considerati efficaci, indipendentemente dall'indicazione, assunti nei 30 giorni precedenti la visita di screening.
    b) Analgesici (ad esempio, farmaci antinfiammatori non steroidei [FANS] o acetaminofene) assunti = 15 giorni al mese nei 3 mesi (12 settimane) precedenti la visita di screening.
    c) Farmaci accettati per il trattamento dell'emicrania acuta con indicazione non emicranica assunti = 15 giorni al mese nei 3 mesi (12 settimane) precedenti la visita di screening.
    d) Farmaci biologici per l'emicrania (come gli anticorpi monoclonali CGRP) assunti nei 6 mesi (24 settimane) precedenti la visita di screening.
    e) Farmaci o dispositivi vietati utilizzati durante la fase di osservazione.
    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 Phase
    Variazione media rispetto alla Fase di osservazione nel numero di giorni di emicrania al mese nell’intera Fase di trattamento in doppio cieco
    E.5.1.1Timepoint(s) of evaluation of this end point
    Weeks 1 to 12
    Settimane da 1 a 12
    E.5.2Secondary end point(s)
    1. Proportion of subjects with = 50% reduction from the Observation Phase in the number of moderate to severe migraine days per month over the entire Double-blind Treatment Phase (Weeks 1 to 12).
    2. 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 Double-blind Treatment Phase.
    3. 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 Double-blind Treatment Phase.
    4. Mean number of acute migraine-specific medication days per month over the entire Double-blind Treatment Phase (Weeks 1 to 12). Acute migraine-specific medications are triptans and ergotamine.
    5. Mean change from baseline in the MSQ restrictive role function domain score at Week 12 of the Double-blind Treatment Phase.
    6. Number and percentage of subjects with AEs by intensity, serious adverse events (SAEs), AEs leading to study drug discontinuation, and grade 3 to 4 laboratory test abnormalities during the Double-blind Treatment and Open-label Extension Phases.
    7. Number and percentage of subjects treated with rimegepant with AST or ALT elevations > 3x ULN concurrent (i.e., on the same laboratory collection date) with total bilirubin > 2x ULN during the Double-blind Treatment and Open-label Extension Phases.
    8. Number and percentage of subjects treated with rimegepant with hepatic-related AEs by intensity, and hepatic-related AEs leading to study drug discontinuation during the Doubleblind Treatment and Open-label Extension Phases.
    1. Percentuale di soggetti con riduzione di = 50% della Fase di osservazione nel numero di giorni di emicrania da moderata a grave al mese nell’intera Fase di trattamento in doppio cieco (Settimane da 1 a 12).
    2. Variazione media rispetto alla Fase di osservazione nel numero di giorni di emicrania al mese nelle ultime 4 settimane (Settimane 9-12) della Fase di trattamento in doppio cieco.
    3. Variazione media dalla Fase di osservazione nel numero di giorni di emicrania al mese nelle prime 4 settimane (Settimane da 1 a 4) della Fase di trattamento in doppio cieco.
    4. Numero medio di giorni di farmaci sintomatici specifici per l’emicrania al mese nell’intera Fase di trattamento in doppio cieco (Settimane da 1 a 12). I farmaci sintomatici specifici per l’emicrania sono triptani ed ergotamina.
    5. Variazione media rispetto al basale nel punteggio del dominio della funzione di ruolo restrittivo dell’MSQ alla Settimana 12 della Fase di trattamento in doppio cieco.
    6. Numero e percentuale di soggetti con EA per intensità, eventi avversi seri (Serious Adverse Events, SAE), EA che portano all’interruzione del farmaco dello studio e anomalie negli esami di laboratorio di grado da 3 a 4 durante le Fasi di trattamento in doppio cieco e di estensione in aperto.
    7. Numero e percentuale di soggetti trattati con rimegepant con aumenti di AST o ALT > 3 volte l’ULN concomitanti (ovvero, alla stessa data di prelievo di laboratorio) con bilirubina totale > 2 volte l’ULN durante le Fasi di trattamento in doppio cieco e di estensione in aperto.
    8. Numero e percentuale di soggetti trattati con rimegepant con EA epatici per intensità ed EA epatici che portano all’interruzione del farmaco dello studio durante le fasi di trattamento in doppio cieco e di estensione in aperto.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the study
    Per tutta la durata dello studio
    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 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 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) 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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    È prevista una fase opzionale di 12 settimane in aperto, dopo la fase di trattamento in doppio cieco
    There is an optional 12-week open-label phase, after the double-blind treatment phase
    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 trial3
    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 concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA65
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Israel
    United States
    Austria
    France
    Poland
    Sweden
    Spain
    Germany
    Italy
    United Kingdom
    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
    LVLS
    LVLS
    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 months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    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: 624
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 36
    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 state78
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 330
    F.4.2.2In the whole clinical trial 660
    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)
    None
    Nessuno
    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 Decision2022-09-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-07-26
    P. End of Trial
    P.End of Trial StatusOngoing
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