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    Summary
    EudraCT Number:2018-000734-35
    Sponsor's Protocol Code Number:TV48125-CNS-10141
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-07-25
    Trial results View 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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2018-000734-35
    A.3Full title of the trial
    A Single-Dose, Open-Label Study to Characterize the Pharmacokinetics, Safety and Tolerability of Subcutaneous
    administration of Fremanezumab in Pediatric Migraine Patients (6 to 11 Years of Age Inclusive)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to characterize the Pharmacokinetics, Safety and Tolerability of Subcutaneous
    administration of Fremanezumab in Paediatric Migraine Patients (6 to 11 Years of Age Inclusive)
    A.4.1Sponsor's protocol code numberTV48125-CNS-10141
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/308/2017
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorTeva Branded Pharmaceutical Products R&D, 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 supportTeva Branded Pharmaceutical Products R&D, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTeva GmbH
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressGraf-Arco-Strasse-3
    B.5.3.2Town/ cityUlm
    B.5.3.3Post code89079
    B.5.3.4CountryGermany
    B.5.4Telephone number000000000000
    B.5.5Fax number000000000000
    B.5.6E-mailInfo.Era-clinical@teva.de
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameFremanezumab
    D.3.2Product code TEV-48125
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFREMANEZUMAB
    D.3.9.2Current sponsor codeTEV-48125
    D.3.9.4EV Substance CodeSUB186896
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prevention of migraine
    E.1.1.1Medical condition in easily understood language
    Prevention of migraine
    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
    A primary objective of this study is to characterize the pharmacokinetic profile of fremanezumab following administration of a single sc dose in pediatric patients with migraine (6 to 11 years of age inclusive)
    E.2.2Secondary objectives of the trial
    A secondary objective of the study is to evaluate the safety and tolerability profile of fremanezumab following administration of a single sc dose in pediatric patients with migraine (6 to 11 years of age inclusive)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a. Male or female children are 6 to 11 years of age inclusive (at the time of assent of the patient and/or consent of parent(s)/guardian[s]).
    b. Written informed consent is obtained from each patient’s parent(s) or legal guardian(s) and assent (according to local regulations) is obtained from each patient.
    c. Patient has been diagnosed with migraine (International Classification of Headache Disorders, ICHD-3; see Appendix D for details).
    d. Females of childbearing potential must not be sexually active and must have a negative urine beta human chorionic gonadotropin (β-HCG) test at screening.
    e. The patient is in good health as determined by a medical and psychiatric history, physical examination, 12-lead ECG, and clinical laboratory tests including serum chemistry, hematology, coagulation, and urinalysis.
    f. The patient and parent(s)/legal guardian(s) must be willing and able to comply with study restrictions and with the requirement for the patient to remain at the clinic for the required duration during the study period, and be willing to return to the clinic for the follow-up evaluations as specified in this protocol.
    g. The patient is able to understand and follow study instructions alone or with parental(s)/legal guardian(s) assistance.
    h. The patient weighs at least 17.0 kg and less than 45.0 kg.
    E.4Principal exclusion criteria
    a. Clinically significant hematologic, cardiac, renal, endocrine, pulmonary, gastrointestinal, genitourinary, neurologic, psychiatric, ocular or any other disease, at the discretion of the investigator.
    b. Any biologic drugs (for example: TNF-α inhibitors such as adalimumab, etanercept or infliximab) within 3 months or 5 half-lives (whichever is longer) before first dose of fremanezumab.
    c. Any finding that, in the judgment of the investigator, is a clinically significant abnormality, including physical examination and vital signs as blood pressure and heart rate (abnormal may be repeated up to 3 times for confirmation).
    d. Any finding that, in the judgment of the investigator, is clinically significantly abnormal, including hematology, blood chemistry, coagulation, or urinalysis results. (Note: Abnormal tests may be repeated for confirmation.) Patient has a positive cotinine test (>300 ng/mL) at screening or check-in.
    e. Patient with evidence or medical history of clinically significant psychiatric issues including any suicide attempt or any significant risk of suicide (any suicidal ideation in the past 6 months).
    f. History of clinically significant cardiovascular disease or vascular ischemia (such as myocardial, neurologic [eg, cerebral ischemia], peripheral extremity ischemia, or other ischemic event) or thromboembolic events (arterial or venous thrombotic or embolic events), such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism.
    g. Ongoing infection, or known history of human immunodeficiency virus (HIV) infection, tuberculosis, or chronic hepatitis B or C.
    h. Any finding in the baseline 12-lead ECG considered clinically significant in the judgment of the investigator
    i. Any past or current history of cancer.
    j. Any pregnant female.
    k. History of hypersensitivity reactions to injected proteins, including monoclonal antibodies, or any other component of the formulation.
    l. The patient has participated in another study of an IMP (or a medical device) within the previous 30 days (or 90 days for biologics) or 5 half-lives of the IMP, whichever is longer, or is currently participating in another study of an IMP (or a medical device).
    m. Any prior exposure to a monoclonal antibody targeting the CGRP pathway (AMG 334, ALD304, LY2951742, TEV-48125).
    n. Hepatic enzymes (alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase [ALP]) more than 1.5 times the upper limit of normal (ULN) for that age after confirmation in a repeat test.
    o. Serum creatinine >1.5 times the ULN, clinically significant proteinuria (urine dipstick +4), or evidence of renal disease at screening.
    p. History of alcohol or drug abuse.
    q. The patient cannot participate or successfully complete the study, in the opinion of the investigator, for any of the following reasons:
    - The patient is mentally or legally incapacitated, or unable to give assent or consent for any reason.
    - The patient is in custody due to an administrative or a legal decision, or under tutelage, or being admitted to a sanitarium or social institution.
    - The patient’s parent(s)/legal guardian(s) and/or the patient cannot be contacted in case of emergency. The patient must be accompanied by the parent(s)/legal guardian(s) during patient visit.
    - The patient has any other condition, which, in the opinion of the investigator, makes the patient inappropriate for inclusion in the study.
    - The patient is a relative of a study center or sponsor employee who is directly involved in the study.
    E.5 End points
    E.5.1Primary end point(s)
    The following pharmacokinetic parameters will
    be evaluated to support the primary objective of
    the study:
    - Maximum observed concentration (Cmax)
    - AUC from time 0 to the time of the last
    measurable IMP concentration (AUC0-t)
    - time to maximum observed plasma drug
    concentration (tmax)
    - AUC from time 0 to infinity (AUC0-∞)
    - percentage extrapolated AUC (%AUCext)
    - apparent plasma terminal elimination rate constant (λz) and associated elimination half-life (t½)
    - apparent volume of distribution (Vz/F)
    - apparent clearance (CL/F)
    E.5.1.1Timepoint(s) of evaluation of this end point
    16 weeks
    E.5.2Secondary end point(s)
    The safety endpoints are
    - Occurrence of adverse events throughout the study
    - Vital signs (blood pressure, respiratory rate, body temperature, and pulse) measurements
    - Triplicate 12-lead electrocardiogram (ECG) findings. First ECG will be used for bedside safety assessment and the triplicate ECGs will be sent for central analysis.
    - Physical examination
    - Clinical laboratory (serum chemistry, hematology, urinalysis, and coagulation
    tests)
    - Tolerability at the injection site including clinical findings (ie, pain, erythema,
    induration, and ecchymosis)
    - Concomitant medication usage
    E.5.2.1Timepoint(s) of evaluation of this end point
    16 weeks
    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 Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Pharmacokinetics, Safety and Tolerability in Paediatric Migraine Patients
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    United States
    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.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    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 Yes
    F.1.1Number of subjects for this age range: 15
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 15
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 15
    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
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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