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    Summary
    EudraCT Number:2016-003172-43
    Sponsor's Protocol Code Number:TV48125-CNS-30058
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-01-04
    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
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2016-003172-43
    A.3Full title of the trial
    A Multicenter, Double-Blind, Double-Dummy Study to Explore the Long-Term Safety of TEV-48125 for the Prevention of Cluster Headache
    Estudio multicéntrico, de doble enmascaramiento y doble simulación para explorar la seguridad a largo plazo de TEV-48125 en la prevención de la cefalea en racimos
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial investigating the long-term safety of investigational drug TEV-48125 developed to prevent cluster headache
    Ensayo clínico que investiga la seguridad a largo plazo del fármaco en investigación TEV-48125 desarrollado para prevenir la cefalea en racimos
    A.4.1Sponsor's protocol code numberTV48125-CNS-30058
    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 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.5.6E-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.3.9.1CAS number 1655501-53-3
    D.3.9.2Current sponsor codeTEV 48125
    D.3.9.3Other descriptive namefremanezumab
    D.3.9.4EV Substance CodeSUB181665
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cluster headache (CH)
    cefalea en racimos (CR)
    E.1.1.1Medical condition in easily understood language
    Cluster headache (CH)
    cefalea en racimos (CR)
    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
    The primary objective of this study is to evaluate the long term safety of fremanezumab in adult patients with CH.
    El objetivo principal de este estudio es evaluar la seguridad a largo plazo de fremanezumab en pacientes adultos con CR.
    E.2.2Secondary objectives of the trial
    There are no secondary objectives and secondary endpoints in this study.
    No hay objetivos secundarios ni criterios de valoración secundarios en este estudio.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a.The patient is a male or female 18 to 70 years of age, inclusive
    b.The patient signs and dates the informed consent document.
    c.The patient successfully completes either the Phase 3 pivotal study for ECH (Study TV48125-CNS-30056) or the Phase 3 pivotal study for CCH (Study TV48125-CNS-30057) without important protocol deviations related to patient safety and patient compliance
    In addition, patients who do not complete the pivotal efficacy studies, and patients who complete the pivotal efficacy studies but do not wish to continue treatment during this long-term safety study, may enroll in this study for the purpose of evaluating ADAs, fremanezumab concentrations, and safety (adverse events and concomitant medications) approximately 7.5 months after administration of the last dose of the IMP.
    d.Women may be included only if they have a negative beta-human chorionic gonadotropin test at visit 1; are sterile or postmenopausal.
    e.Women of childbearing potential (WOCBP) whose male partners are potentially fertile (ie, no vasectomy) must use highly effective birth control methods for the duration of the study and for 7.5 months after discontinuation of IMP.
    f.Men must be sterile; or if they are potentially fertile/reproductively competent (not surgically [eg, vasectomy] or congenitally sterile), and their female partners are of childbearing potential, must use, together with their female partners, acceptable birth control methods for the duration of the study and for 7.5 months after administration of IMP.
    Definitions of WOCBP, sterile and postmenopausal women; male contraception; highly effective and acceptable birth control methods
    g.The patient must be willing to stop concomitant medications used in clinical practice for the prevention of CH for the duration of this study. (Note: Patients taking verapamil during the pivotal studies must begin tapering verapamil as soon as they enroll in this study, and they must be off verapamil within 1 month of beginning study participation.)
    h.The patient is in good health in the opinion of the investigator as determined by a medical and psychiatric history; medical examination; 12 lead ECG; and serum chemistry, hematology, coagulation, and urinalysis.
    i.The patient must be willing and able to comply with study restrictions to remain at the clinic for the required duration during the study period and to return to the clinic for the follow up evaluations, as specified in this protocol.
    a.El paciente, hombre o mujer, tiene entre 18 y 70 años de edad, inclusive.
    b.El paciente ha firmado y fechado el documento de consentimiento informado.
    c.El paciente completa satisfactoriamente el estudio pivotal de fase 3 para la CRE (estudio TV48125-CNS-30056) o el estudio pivotal de fase 3 para la CRC (estudio TV48125-CNS-30057) sin desviaciones importantes con respecto al protocolo relacionadas con la seguridad y el cumplimiento del paciente.
    –Además, los pacientes que no completen los estudios de eficacia pivotales y los pacientes que completen dichos estudios pero que no deseen continuar el tratamiento durante este estudio de la seguridad a largo plazo, podrán incluirse en este estudio con el fin de evaluar los AAF, las concentraciones de fremanezumab y la seguridad (acontecimientos adversos y medicamentos concurrentes) aproximadamente 7 meses y medio tras la administración de la última dosis del MEI.
    d.Las mujeres podrán ser incluidas únicamente si obtienen una prueba de gonadotropina coriónica humana beta negativa en la visita 1, si son estériles o si son posmenopáusicas. Las definiciones de estéril y posmenopáusica se pueden encontrar en el Apéndice E.
    e.Las mujeres con capacidad de procrear (MCCDP) cuyas parejas masculinas sean potencialmente fértiles (es decir, sin vasectomía) deben usar métodos de control de la natalidad muy eficaces durante todo el estudio y durante los 7,5 meses posteriores a la interrupción del tratamiento con el MEI.
    f.Los hombres deberán ser estériles; o si son potencialmente fértiles/tienen capacidad reproductiva (no se han sometido a esterilización quirúrgica [p. ej., vasectomía] ni son estériles de forma congénita) y tienen parejas del sexo femenino con capacidad de procrear, deben usar, junto con sus parejas, métodos de control de la natalidad aceptables durante todo el estudio y durante los 7,5 meses posteriores a la administración del MEI.
    Las definiciones de MCCDP, mujeres estériles y posmenopáusicas; contracepción masculina; y métodos de control de la natalidad aceptables y muy efectivos, incluidos ejemplos, se pueden encontrar en el Apéndice E.
    g.Los pacientes deben estar dispuestos a dejar de tomar los medicamentos concomitantes utilizados en la práctica clínica para la prevención de la CR durante todo el estudio. (Nota: Los pacientes que tomen verapamil durante los estudios fundamentales deben empezar a reducir progresivamente el verapamil en cuanto se inscriban en este estudio y deben haber dejado de tomarlo por completo en 1 mes tras empezar su participación en el estudio [Apéndice H]).
    h.En opinión del investigador, el paciente se encuentra en un buen estado de salud, determinado por el historial médico y psiquiátrico; un examen médico; un ECG de 12 derivaciones; así como las pruebas analíticas de bioquímica sérica, hematología, coagulación y análisis de orina.
    i.El paciente debe estar dispuesto y ser capaz de cumplir con las restricciones el estudio, permanecer en la clínica el tiempo necesario durante el periodo del estudio y volver a la clínica para las evaluaciones de seguimiento, tal y como se indica en este protocolo.
    E.4Principal exclusion criteria
    a.Any finding in the 12-lead ECG performed as part of the EOT visit (visit 5) procedures for the pivotal studies considered clinically significant in the judgment of the investigator
    b.Any finding that, in the judgment of the investigator, is a clinically significant abnormality, including serum chemistry, hematology, coagulation, and urinalysis test values (abnormal tests may be repeated for confirmation)
    c.Hepatic enzymes (alanine aminotransferase and aspartate aminotransferase) >1.5 × the upper limit of the normal range (ULN) after confirmation in a repeat test or suspected hepatocellular damage that fulfills criteria for Hy’s law
    d.Serum creatinine >1.5 × the ULN or evidence of clinically significant renal disease in the judgment of the investigator
    a.Algún resultado del ECG de 12 derivaciones realizado como parte de los procedimientos de la visita de FDT (visita 5) de los estudios pivotales se considera relevante desde un punto de vista clínico, a juicio del investigador.
    b.Cualquier resultado que, a juicio del investigador, constituya una anomalía de relevancia clínica, incluidos los resultados de los análisis de bioquímica sérica, hematología, coagulación y de orina (los análisis con anomalías se pueden repetir para confirmarlos).
    c.Enzimas hepáticas (alanina aminotransferasa y aspartato aminotransferasa) >1,5 × el límite superior de la normalidad (LSN) tras confirmación en una repetición de la prueba o sospecha de lesión hepatocelular que cumpla los criterios de la ley de Hy.
    d.Creatinina en suero >1,5 × el LSN o signos de enfermedad renal clínicamente significativa a juicio del investigador.
    E.5 End points
    E.5.1Primary end point(s)
    Safety endpoints are as follows:
    •occurrence of adverse events throughout the study
    •changes from baseline (day 0 of the Phase 3 pivotal efficacy studies) in clinical laboratory (serum chemistry, hematology, coagulation, and urinalysis) test results
    •changes from baseline (day 0 of the Phase 3 pivotal efficacy studies) in vital signs (pulse, systolic and diastolic blood pressure, and oral temperature) measurements
    Note: Oxygen saturation will be measured in cases of suspected anaphylaxis and severe hypersensitivity. Respiratory rate will also be measured in these cases but not as a standard vital sign.
    •abnormal standard 12-lead electrocardiogram (ECG) findings
    •clinically significant changes in physical examination, including body weight
    •occurrence of injection site reactions (ie, erythema, induration, and ecchymosis) and injection site pain
    •occurrence of anaphylaxis and hypersensitivity reactions
    •use of concomitant medications during the study
    •suicidal ideation and behavior as measured by the electronic Columbia Suicide Severity Rating Scale (eC-SSRS)
    Los criterios de valoración de la seguridad son los siguientes:
    •Aparición de acontecimientos adversos durante el estudio.
    •Cambios respecto al valor de referencia (día 0 de los estudios de eficacia pivotales de fase 3) en los resultados de las pruebas analíticas (bioquímica sérica, prueba hematológica, test de coagulación y análisis de orina).
    •Cambios respecto al valor de referencia (día 0 de los estudios de eficacia pivotales de fase 3) en las mediciones de las constantes vitales (pulso, tensión sanguínea sistólica y diastólica y temperatura oral).
    Nota: Se medirá la saturación de oxígeno en aquellos casos en los que se sospeche anafilaxia e hipersensibilidad intensa. En estos casos, también se medirá la frecuencia respiratoria, pero no como constante vital estándar.
    •Resultados anómalos en un electrocardiograma (ECG) estándar de 12 derivaciones.
    •Cambios con transcendencia clínica en la exploración física, incluido el peso corporal.
    •Aparición de reacciones en la zona de inyección (eritema, induración y equimosis) y dolor en la zona de inyección.
    •Incidencia de anafilaxia y reacciones de hipersensibilidad.
    •Uso de medicamentos concomitantes durante el estudio.
    •Evaluación de las ideas y del comportamiento suicidas utilizando la Escala Columbia para evaluar el riesgo de suicidio en formato electrónico (eC SSRS).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to end of trial
    Periodo inicial hasta el fin de ensayo
    E.5.2Secondary end point(s)
    N/A
    N/A
    E.5.2.1Timepoint(s) of evaluation of this end point
    N/A
    N/A
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 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 Yes
    E.8.2.3.1Comparator description
    Different dosing regimen of fremanezumab
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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
    Australia
    Canada
    Finland
    Germany
    Israel
    Italy
    Netherlands
    Poland
    Spain
    Sweden
    United Kingdom
    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
    End of study is defined as the date the last patient attends the follow-up visit
    El fin del estudio se define como la fecha en que el último paciente acudea la visita de seguimiento
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days9
    E.8.9.2In all countries concerned by the trial years3
    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: 284
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 16
    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 state26
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 300
    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)
    N/A
    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 Decision2017-03-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-04-23
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