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    Summary
    EudraCT Number:2021-005239-22
    Sponsor's Protocol Code Number:BHV3000-404_C4951010
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-06-17
    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 ConcernedSweden - MPA
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The purpose of this study is to compare the efficacy and safety of daily and every other day dosing of rimegepant to placebo as a preventive treatment for episodic migraine.
    A.4.1Sponsor's protocol code numberBHV3000-404_C4951010
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05217927
    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 Center
    B.5.3 Address:
    B.5.3.1Street Address66 Hudson Boulevard East
    B.5.3.2Town/ cityNew York
    B.5.3.3Post code1001
    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 75mg
    D.3.2Product code PF-07899801
    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 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
    Acute Migraine (with or without aura)
    E.1.1.1Medical condition in easily understood language
    Migraine
    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 10052787
    E.1.2Term Migraine without aura
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10027607
    E.1.2Term Migraine with aura
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10027603
    E.1.2Term Migraine headaches
    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 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.
    E.2.2Secondary objectives of the trial
    Evaluate the proportion of subjects with >50% reduction from the Observation Phase(OP) in the # of moderate to severe migraine days per month(dpm)over the entire Double-blind Treatment Phase(DBT) for the EOD and daily rimegepant dosing regimens relative to placebo(P)
    Evaluate the mean reduction from the OP in the # of migraine dpm in the last 4 weeks of the Doubleblind Treatment Phase for the EOD and daily rimegepant dosing regimens relative to P
    Evaluate the mean reduction from the Evaluate in the # of migraine dpm in the first 4weeks of the DBT Phase for the EOD and daily rimegepant dosing regimens relative to P
    Evaluate the mean # of acute migraine-specific medication dpm over the entire DBT for the EOD and daily rimegepant dosing regimens relative to P
    Evaluate the mean change from baseline in the Migraine-Specific Quality-of-Life Questionnaire restrictive role function domain score at W12
    Evaluate safety and tolerability of rimegepant
    Other objectives in the protocol
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Signed Written Informed Consent
    a)Written informed consent must be obtained from the subject in accordance with requirements of the study center’s institutional review board (IRB) or ethics committee, prior to the initiation of any protocol-required procedures.
    2.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 Edition4, 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).
    d)4 or more migraine days during 28 days in the Observation Phase.
    e)Not more than 14 headache days during 28 days in the Observation Phase.
    f)Ability to distinguish migraine attacks from tension/cluster headaches.
    g)Subjects with contraindications for use of triptans may be included provided they meet all other study entry criteria.
    3.Age and Reproductive Status
    a)Male and female subjects ≥ 18 years.
    b)Women of childbearing potential (WOCBP) and non-sterile men must be using two acceptable methods of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized. See Section 5.6 for the definition of WOCBP. Males with vasectomy are considered surgically sterile provided the procedure occurred greater than 6 months (24 weeks) prior to study participation.
    c)At the Baseline Visit, WOCBP must have a negative pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) before dosing with study drug.
    4.No clinically significant abnormality identified on the medical or laboratory evaluation. A subject with a clinical abnormality or laboratory parameters outside the reference range may be included only if the investigator considers the finding not clinically significant, that it will not introduce additional risk factors, nor interfere with the study procedures (not including exclusion criteria listed in Section 5.3 of the protocol).
    E.4Principal exclusion criteria
    1.Target Disease Exclusion
    a)Subject has a history of basilar migraine, hemiplegic migraine, retinal migraine or migraine accompanied by diplopia or decreased level of consciousness as defined by International Classification of Headache Disorders, 3rd Edition.
    b)Subjects with headaches occurring 15 or more days per month (migraine or non-migraine) in any of the 3 months prior to the Screening Visit.
    2.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, acute coronary syndrome, percutaneous coronary intervention, cardiac surgery, stroke or transient ischemic attack during the 6 months prior to the Screening Visit.
    b)Uncontrolled hypertension or uncontrolled diabetes. However, subjects can be included who have stable hypertension and/or diabetes for 3 months prior to the Screening Visit. Blood pressure greater than 150 mmHg systolic or 100 mmHg diastolic after 10 minutes of rest is exclusionary. This may be repeated once at screening once during visit to confirm reproducibility.
    c)Subjects with major depressive or any anxiety disorder which require more than 1 daily medication for each disorder or subjects with major depressive episode within last 12 months. Medications to treat major depressive disorder or an anxiety disorder must have been at a stable dose for at least 3 months prior to the Screening Visit.
    d)Active chronic pain syndromes
    e)Subjects with other pain syndromes (including trigeminal neuralgia), psychiatric conditions, dementia, or significant neurological disorders (other than migraine) that, in the Investigator’s opinion, might interfere with study assessments of safety or efficacy.
    f)Diagnosis of active biliary disorder.
    g)Subject has a history of gastric, or small intestinal surgery, or has a disease or condition that causes malabsorption.
    h)Subject has a history or diagnosis of any active hepatic disorder.
    i)The subject has a history or current evidence of any unstable medical conditions that, in the investigator’s opinion, would expose them to undue risk of a significant adverse event or interfere with assessments of safety or efficacy during the course of the study.
    j)History of, treatment for, or evidence of, alcohol or drug abuse within the past 12 months or subjects who have met DSM-V criteria10 for any significant substance use disorder within the past 12 months from the Screening Visit according to PI assessment.
    k)History of use of narcotics, such as opioids for ≥4 days per month during the 3 months prior to the Screening Visit.
    l)Subjects should be excluded if they have a 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.
    m)Hematologic or solid malignancy diagnosis within 5 years prior to the Screening Visit. Subjects with a history of localized basal cell or squamous cell skin cancer are eligible for the study if they are cancer-free prior to the Screening Visit in this study.
    n)Subject has current diagnosis of major depressive disorder requiring treatment with atypical antipsychotics, schizophrenia, bipolar disorder, or borderline personality disorder.
    o)Body mass index > 35.0 kg/m2.
    3.History of anaphylaxis to any substance or a clinically important reaction to any drug.
    4.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.
    5.ECG and Laboratory Test Findings
    a)Estimated glomerular filtration rate according to the re-expressed abbreviated Modification of Diet in Renal Disease Study equation ≤ 30 ml/min/1.73m2.
    b)Abnormal ECG that in the investigator’s opinion makes the subject unsuitable for a clinical trial
    c)Total serum bilirubin > 1.5 x ULN.
    d)AST or ALT > 1.5 x ULN.
    e)Serum albumin < 2.8 g/dL.
    f)Neutrophil count ≤ 1000/μL
    g)HbA1c > 7.5%
    6.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 taken ≥ 15 days per month during the 3 months 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 prior to the Screening Visit.
    d)Biologic migraine medication taken during the 6 months prior to the Screening Visit.
    e)Prohibited medication or device used during the Observation Phase
    For a complete exclusion criteria review please refer to the protocol.
    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 (Weeks 1 to 12).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Weeks 1 to 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.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the study
    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
    There is an optional 12-week open-label phase, after the double-bind 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    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 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
    Canada
    Israel
    United Kingdom
    United States
    Austria
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months15
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months20
    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 state30
    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
    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 Decision2022-09-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-08-10
    P. End of Trial
    P.End of Trial StatusOngoing
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