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    Summary
    EudraCT Number:2022-001175-14
    Sponsor's Protocol Code Number:BHV3000-406
    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:2022-12-20
    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 number2022-001175-14
    A.3Full title of the trial
    BHV3000-406: A Phase 4, Randomized, Double-blind Placebo-Controlled, Efficacy and Tolerability Trial of Rimegepant for the Acute Treatment of Migraine in Adults Unsuitable for Triptan Use
    BHV3000-406: Eine randomisierte, doppelblinde, placebokontrollierte Phase-IV-Studie zur Wirksamkeit und Verträglichkeit von Rimegepant zur Akutbehandlung von Migräne bei Erwachsenen, die nicht für die Einnahme von Triptanen in Frage kommen
    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 Acute Migraine Attacks in Adults for whom Triptans are unsuitable
    Eine Studie zur Wirksamkeit und Verträglichkeit von Rimegepant zur Akutbehandlung von Migräne bei Erwachsenen, die nicht für die Einnahme von Triptanen in Frage kommen
    A.4.1Sponsor's protocol code numberBHV3000-406
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05509400
    A.5.4Other Identifiers
    Name:IND NumberNumber: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 attacks with or without aura
    akuten Migräneanfällen mit oder ohne Aura
    E.1.1.1Medical condition in easily understood language
    accute migraine attacks with or without aura
    akuten 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 with placebo in the acute treatment of migraine, as measured by migraine headache pain relief at 2 hours postdose during the DBT Phase.
    Vergleich der Wirksamkeit von Rimegepant mit Placebo bei der akuten Behandlung von Migräne, gemessen an der Schmerzlinderung bei Migränekopfschmerzen 2 Stunden nach der Einnahme während der DBT-Phase.
    E.2.2Secondary objectives of the trial
    Key Secondary Objectives are to compare Rimegepant with placebo for:
    1.migraine headache pain freedom at 2 hours postdose during the DBT Phase
    2.rescue medication use within 24 hours postdose during the DBT Phase
    3.return to normal function, as measured by FDS, at 2 hours postdose during the DBT Phase
    4.sustained return to normal function, as measured by FDS, from 2 to 24 hours postdose during the DBT Phase
    5.sustained return to normal function, as measured by FDS, from 2 to 48 hours postdose during the DBT Phase
    6.sustained migraine headache pain relief from 2 to 24 hours postdose during the DBT Phase
    7.sustained migraine headache pain relief from 2 to 48 hours postdose during the DBT Phase
    8.sustained migraine headache pain freedom from 2 to 24 hours postdose during the DBT Phase
    9.sustained migraine headache pain freedom from 2 to 48 hours postdose during the DBT Phase
    10.freedom from the MBS associated with migraine at 2 hours postdose during the DBT Phase
    Vergleich von Rimegepant mit Placebo (währen DBT-Phase):
    - hinsichtlich der Schmerzfreiheit bei Migränekopfschmerzen 2 SnE
    - in Bezug auf die Verwendung von Notfallmedikamenten innerhalb von 24 SnE
    - in Bezug auf die Rückkehr zur normalen Funktion, gemessen anhand der Skala für funktionelle Behinderung, 2 SnE
    - in Bezug auf die anhaltende Rückkehr zur normalen Funktion, gemessen anhand der Skala für funktionelle Behinderung, 2 bis 24 une bis 48 SnE
    - in Bezug auf die anhaltende Schmerzlinderung bei Migräne im Zeitraum von 2 bis 24 SnE
    - in Bezug auf die anhaltende Schmerzlinderung bei Migräne im Zeitraum von 2 bis 48 SnE
    - in Bezug auf die anhaltende Schmerzfreiheit bei Migräne im Zeitraum von 2 bis 24 SnE
    - in Bezug auf die anhaltende Schmerzfreiheit bei Migräne im Zeitraum von 2 bis 48 SnE
    - in Bezug auf die anhaltende Schmerzfreiheit bei Migräne im Zeitraum von 2 bis 48 SnE
    SnE=Stunden nach der Einnahme
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Target Population:
    Minimum 1 year documented history of migraine attacks (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition
    Per self-report, with confirmation from Investigator / supporting medication record, subjects must have:
    a. Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age
    b. Migraine attacks, on average, lasting about 4 - 72 hours if untreated
    c. 4 to 14 migraine days per month on average across the 3 months prior to the Screening Visit (month is defined as 28 days for the purpose of this protocol)
    d. Subjects must be able to distinguish migraine attacks from tension headaches
    e. Subjects on prophylactic migraine medication (excluding CGRP antagonists) are permitted to remain on therapy if they have been on a stable dose for at least 3 months (12 weeks) prior to the Screening Visit, and if the dose is not expected to change during the course of the study

    2. Triptan unsuitable

    3. Age and Reproductive Status
    a. Male and Female subjects >=18 years of age
    b. Women of childbearing potential (WOCBP) with non-sterile male partners and non-sterile men with female partners of childbearing potential must use two methods of contraception (with at least 1 highly effective method and 1 additional method) to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized
    c. At the Baseline Visit prior to dispensing investigational study drug, WOCBP must have a negative urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG)
    4. Subjects must be able to fully comply with the prohibitions and restrictions on the concomitant use of medications and therapies (including moderate to strong inhibitors and inducers of the CYP3A4 enzyme and strong inhibitiors of the P-gp transporter)
    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) Headaches occurring 15 or more days per month (migraine or non-migraine) in any of the 3 months prior to Screening Visit (SV)
    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 12 months from the SV
    d) Current diagnosis schizophrenia, bipolar, or borderline personality disorder
    e) History or current evidence of other major psychiatric disorder that might interfere with the ability to properly report clinical outcomes
    f) Major depressive (MDD) or any anxiety disorder which requires more than 1 daily medication for each disorder, or major depressive episode within last 12 months
    g) Active chronic pain syndrome
    h) Other pain syndromes, dementia, or significant neurological disorders (other than migraine)
    i) Current diagnosis of MDD requiring treatment with atypical antipsychotics
    j) History with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease during 24 weeks prior to SV
    k) Systolic blood pressure >150 mmHg or diastolic blood pressure > 100 mmHg after 10 minutes of rest
    l) History or current evidence of any unstable medical conditions
    m) Positive 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. Rimegepant is contraindicated in subjects with a hypersensitivity to any component of its formulation.
    4. Sex and Reproductive Status:
    a) WOCBP who are unwilling or unable to use required contraception
    b) Women who are pregnant, lactating or breastfeeding
    c) Women with a positive pregnancy test at SV or prior to study drug administration
    5. ECG and Laboratory Test Findings - as specified in the protocol

    6. Prohibited Medications and Devices
    a) Non-Narcotic Analgesics taken at least 15 days per month for a non-headache indication during the 12 weeks prior to SV
    b) Other CGRP antagonists (beyond rimegepant), including:
    i. CGRP antagonist monoclonal antibodies taken within 24 weeks prior SV
    ii. CGRP antagonist small molecules taken within 10 days prior SV
    c) Botulinum toxin injections (e.g., Botox®) used for the prevention of migraine taken within 3 months (12 weeks) prior to the SV
    d) Cefaly or any other device for migraine treatment or prevention used within 12 weeks prior SV
    e) Ergotamine taken at least 10 days per month on a regular basis for at least 12 weeks in the year prior SV
    f) Narcotics, such as opioids or barbiturates taken at least 4 days per month during 12 weeks prior SV
    g) Permitted acute migraine medication taken at least 15 days per month for a non-migraine indication during 12 weeks prior SV
    7. Other:
    a) Exposure to non-biological investigational agents within 30 days prior SV
    b) Exposure to biological investigational agents within 24 weeks prior SV
    c) Subjects who meet criteria for C-SSRS Suicidal Ideation Items 4 or 5 within the last 12 months OR subjects who endorse any of the 5 C-SSRS Suicidal Behavior Items within the last 10 years, OR subjects who, in the opinion of the Investigator, present a serious risk of suicide
    d) Previous enrollment in any multiple dose BHV3000 (PF-07899801) study. Subjects may be considered for BHV3000-406 (C4951004) 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 investigational clinical trial while participating in this clinical trial.
    f)Past participation in a clinical study within 30 days prior SV
    g) Failure to complete the Baseline Visit within the timeframe specified in the schedule of assessments
    h) Subject considered to be otherwise clinically unsuitable for participation in the study including inability to complete the eDiary independently l. Site staff directly involved in the conduct of the study and their family 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)
    Percentage of subjects with a headache pain intensity of none or mild at 2 hours postdose in the DBT Phase. Migraine headache pain intensity will be measured on a 4-point numeric rating scale (0=none, 1=mild, 2=moderate, 3=severe).
    E.5.1.1Timepoint(s) of evaluation of this end point
    DBT (Double Blind Treatment) phase (up to 45 days)
    E.5.2Secondary end point(s)
    Key Secondary Endpoints
    1. Percentage of subjects with a headache pain intensity of none at 2 hours postdose in the DBT Phase.
    2. Percentage of subjects who take rescue medication within 24 hours after taking study drug in the DBT Phase.
    3. Percentage of subjects with a functional disability level of normal at 2 hours postdose in the DBT Phase in the subset of subjects with functional disability at the time of dosing. Functional disability level will be measured on a 4-point numeric rating scale (0=normal, 1=mildly impaired, 2=severely impaired, 3=requires bedrest), and functional disability is defined as mildly impaired, severely impaired, or requires bedrest.
    4. Percentage of subjects with functional disability levels of normal at all time points from 2 to 24 hours postdose in the DBT Phase in the subset of subjects with functional disability at the time of dosing.
    5. Percentage of subjects with functional disability levels of normal at all time points from 2 to 48 hours postdose in the DBT Phase in the subset of subjects with functional disability at the time of dosing.
    6. Percentage of subjects with headache pain intensities of none or mild at all time points from 2 to 24 hours postdose in the DBT Phase.
    7. Percentage of subjects with headache pain intensities of none or mild at all time points from 2 to 48 hours postdose in the DBT Phase.
    8. Percentage of subjects with headache pain intensities of none at all time points from 2 to 24 hours postdose in the DBT Phase.
    9. Percentage of subjects with headache pain intensities of none at all time points from 2 to 48 hours postdose in the DBT Phase.
    10. Percentage of subjects with an MBS that is reported on study before dosing and is absent at 2 hours postdose in the DBT Phase. The MBS on study before dosing will be reported as nausea, phonophobia, or photophobia. Symptom status will be reported postdose as present or absent for each symptom (nausea, phonophobia, and photophobia).
    E.5.2.1Timepoint(s) of evaluation of this end point
    DBT (Double Blind Treatment) phase (up to 45 days)
    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 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 No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Study covers a DBT phase (up to 45 days), followed by an OLE (up to 12 weeks) 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 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 EEA55
    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 months0
    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 state27
    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)
    The study consists of double blind treatment, ope-label extension and follow-up period. 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 treatment of acute 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 Decision2023-02-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-07-04
    P. End of Trial
    P.End of Trial StatusOngoing
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