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    Summary
    EudraCT Number:2021-003015-26
    Sponsor's Protocol Code Number:AMZ002-002
    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:2021-10-25
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2021-003015-26
    A.3Full title of the trial
    A Phase 3, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of AMZ002, Compared to Vigabatrin, in the Treatment of Infantile Spasms
    Estudio en fase III, aleatorizado y abierto para evaluar la eficacia y la seguridad de AMZ002, en comparación con vigabatrina, en el tratamiento de espasmos infantiles
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of Infantile Spasms
    tratamiento de espasmos infantiles
    A.4.1Sponsor's protocol code numberAMZ002-002
    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 SponsorAmzell B.V.
    B.1.3.4CountryNetherlands
    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 supportAmzell B.V.
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmzell B.V.
    B.5.2Functional name of contact pointProject Management
    B.5.3 Address:
    B.5.3.1Street AddressSiriusdreef 31
    B.5.3.2Town/ cityHoofddorp
    B.5.3.3Post code2132 WT
    B.5.3.4CountryNetherlands
    B.5.4Telephone number312355 60 460
    B.5.5Fax number312355 60 461
    B.5.6E-maillaetitia.delpy@bazell-pharma.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 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 nameAMZ002
    D.3.2Product code AMZ002
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVigabatrin
    D.3.9.1CAS number 60643-86-9
    D.3.9.2Current sponsor codeAMZ002
    D.3.9.4EV Substance CodeSUB00048MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Sabril
    D.2.1.1.2Name of the Marketing Authorisation holderAventis Pharma Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameSabril
    D.3.2Product code Vigabatrin
    D.3.4Pharmaceutical form Granules for oral solution
    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 INNVigabatrin
    D.3.9.1CAS number 60643-86-9
    D.3.9.4EV Substance CodeSUB00048MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Monotherapy for the treatment of infantile spasms (IS) in infants and children
    2 months to 24 months of age
    Monoterapia para el tratamiento de espasmos infantiles (EI) en lactantes y niños de 2 a 24 meses de edad, ambos inclusive
    E.1.1.1Medical condition in easily understood language
    Infantile Spasms
    Espasmos infantiles
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10021750
    E.1.2Term Infantile spasms
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10021751
    E.1.2Term Infantile spasms, with intractable epilepsy
    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 LLT
    E.1.2Classification code 10021752
    E.1.2Term Infantile spasms, without mention of intractable epilepsy
    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
    The primary objective of this study is to evaluate the efficacy of AMZ002 in patients who are 2 months to 24 months of age, inclusive, with newly diagnosed IS, compared to vigabatrin.
    El objetivo principal de este estudio es evaluar la eficacia de AMZ002 en pacientes de 2 a 24 meses de edad, inclusive, con EI de diagnóstico reciente, en comparación con vigabatrina.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are the following:
    • To evaluate the safety of AMZ002 in patients who are 2 months to 24 months of age, inclusive, with newly diagnosed IS; and
    • To evaluate the pharmacodynamics (PD) of AMZ002 in patients who are 2 months to
    24 months of age, inclusive, with newly diagnosed IS.
    Los objetivos secundarios de este estudio son los siguientes:
    • Evaluar la seguridad de AMZ002 en pacientes de 2 a 24 meses de edad, ambos inclusive, con EI de diagnóstico reciente; y
    • Evaluar la farmacodinámica (FD) de AMZ002 en pacientes de 2 a 24 meses de edad, ambos inclusive, con EI de diagnóstico reciente.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria
    Patients who meet all of the following criteria will be eligible to participate in the study:
    1. Patient is male or female and is 2 months to 24 months of age, inclusive;
    2. Patient has been diagnosed with IS within 6 weeks prior to Screening. Diagnostic criteria
    include both clinical spasms and an electroencephalogram (EEG) pattern consistent with hypsarrhythmia or significant abnormality compatible with IS;
    NOTE: If a video EEG is performed at the clinical site within 48 hours prior to the patient’s parent/guardian providing written informed consent, and it meets the criteria, this video EEG
    may be used as the screening/baseline EEG for the study.
    3. Patient has normal renal function as defined by an estimated glomerular filtration rate (eGFR) >60 mL/min/1.73 m2, calculated as eGFR = 0.413 × (height [cm] / serum creatinine [mg/dL]);
    4. Patient’s legally authorized representative (ie, parent or guardian) must provide written informed consent obtained per Institutional Review Board policy and requirements, consisten with the International Council for Harmonisation; and
    5. Patient’s parent/guardian is able to understand and willing to comply with study procedures and restrictions.
    Los pacientes que cumplan todos los criterios siguientes serán aptos para participar en el estudio:
    1. El paciente es hombre o mujer y tiene entre 2 y 24 meses de edad, inclusive.
    2. El paciente ha sido diagnosticado con EI en las 6 semanas anteriores a la selección. Los criterios diagnósticos incluyen tanto espasmos clínicos como un patrón electroencefalográfico (EEG) coherente con hipsarritmia o anomalía significativa compatible con EI;
    NOTA: si se realiza un vídeo-EEG en el centro clínico en las 48 horas anteriores a que el progenitor/tutor del paciente proporcione el consentimiento informado por escrito y cumple los criterios, este vídeo-EEG puede utilizarse como EEG de selección/inicio para el estudio.
    3. El paciente tiene una función renal normal definida por una tasa de filtración glomerular estimada (TFGe) >60 ml/min/1,73 m2, calculada como TFGe = 0,413 × (altura [cm]/creatinina sérica [mg/dl]);
    4. El representante legal del paciente (es decir, el progenitor o tutor) debe proporcionar el consentimiento informado por escrito obtenido según la política y los requisitos del Comité de Ética de la Investigación con medicamentos, de conformidad con la Conferencia Internacional sobre la Armonización; y
    5. El progenitor/tutor del paciente es capaz de comprender y está dispuesto a cumplir con los procedimientos y restricciones del estudio.
    E.4Principal exclusion criteria
    Patients who meet any of the following criteria will be excluded from participation in the study:
    1. Patient has been diagnosed with tuberous sclerosis;
    2. Patient has acute illness considered clinically significant by the Investigator within 30 days prior to Screening;
    3. Patient has a diagnosis of recent systemic fungal infection; history of ocular herpes simplex;
    history of or current peptic ulcer; uncontrolled hypertension or congestive heart failure; or any other condition that would be significantly impacted by the study drug;
    4. Patient has a preplanned surgery or procedure(s) that would interfere with the conduct of the study;
    5. Patient has received any prior treatment for IS;
    6. Patient has been previously treated with adrenocorticotropic hormone (ACTH),
    corticosteroids, or vigabatrin for seizures;
    7. Patient has been previously treated with a course of corticosteroids for an indication other than seizures within 30 days prior to Screening;
    8. Patient has a known or suspected allergy to ACTH or vigabatrin or any component of AMZ002 or vigabatrin;
    9. Patient has used any other investigational drug within 30 days or 5 half-lives prior to the first dose of AMZ002 or vigabatrin (whichever is longer);
    10. Patient’s parent/guardian is unable to provide written informed consent and/or to complete the daily diary; or
    11. Patient has any other disease, condition, or therapy that, in the opinion of the Investigator, might compromise safety or compliance, preclude the patient from successfully completing the study, or interfere with the interpretation of the results.
    Los pacientes que cumplan alguno de los criterios siguientes quedarán excluidos de participar en el estudio:
    1. El paciente ha sido diagnosticado de esclerosis tuberosa;
    2. El paciente tiene una enfermedad aguda que el investigador considera clínicamente significativa en los 30 días anteriores a la selección;
    3. El paciente tiene un diagnóstico de infección fúngica sistémica reciente; antecedentes de herpes simple ocular; antecedentes o presencia de úlcera péptica; hipertensión no controlada o insuficiencia cardíaca congestiva; o cualquier otra afección que se vería significativamente afectada por el fármaco del estudio;
    4. El paciente se somete a una intervención quirúrgica o a procedimientos planificados previamente que interferirían con la realización del estudio;
    5. El paciente ha recibido cualquier tratamiento previo para los EI;
    6. El paciente ha sido tratado previamente con hormona adrenocorticotrópica (ACTH), corticosteroides o vigabatrina para las convulsiones;
    7. El paciente ha sido tratado previamente con un ciclo de corticosteroides para una indicación distinta de convulsiones en los 30 días anteriores a la selección;
    8. El paciente tiene una alergia conocida o sospechada a ACTH o vigabatrina o a cualquier componente de AMZ002 o vigabatrina;
    9. El paciente ha usado cualquier otro fármaco en investigación en los 30 días o 5 semividas anteriores a la primera dosis de AMZ002 o vigabatrina (lo que sea más largo);
    10. El progenitor/tutor del paciente no puede proporcionar el consentimiento informado por escrito o cumplimentar el diario todos los días; o
    11. El paciente tiene cualquier otra enfermedad, afección o tratamiento que, en opinión del investigador, podría comprometer la seguridad o el cumplimiento, impedir que el paciente complete el estudio con éxito o interferir con la interpretación de los resultados.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoints
    The co-primary efficacy endpoints are the following:
    • Proportion of patients with absence of clinical spasms at Day 14, as indicated by video EEG; and
    • Proportion of patients with resolution of hypsarrhythmia or significant abnormality compatible with IS at Day 14, as indicated by video EEG.
    Absence of clinical spasms and resolution of hypsarrhythmia or significant abnormality compatible with IS will be determined by an independent, blinded, and central EEG reader.
    Criterios de valoración principales de la eficacia:
    Los criterios de valoración coprincipales de la eficacia son los siguientes:
    • Proporción de pacientes con ausencia de espasmos clínicos en el día 14, según lo indicado por el vídeo-EEG; y
    • Proporción de pacientes con resolución de la hipsarritmia o anomalía significativa compatible con EI en el día 14, según lo indicado por el vídeo-EEG.
    La ausencia de espasmos clínicos y la resolución de la hipsarritmia o las anomalías significativas compatibles con EI la determinará un lector de EEG central, enmascarado e independiente.
    E.5.1.1Timepoint(s) of evaluation of this end point
    -Day 14, as indicated by video EEG
    -Absence of clinical spasms and resolution of hypsarrhythmia
    -Dia 14, según lo indicado por el vídeo-EEG.
    -Ausencia de espasmos clínicos y la resolución de la hipsarritmia.
    E.5.2Secondary end point(s)
    Exploratory Efficacy Endpoints
    The exploratory efficacy endpoints are the following, for patients randomized to the vigabatrin group who are non-responders at Day 14 and then choose to switch to AMZ002 treatment:
    • Proportion of patients with absence of clinical spasms after 14 days of AMZ002 treatment, as indicated by the parent/guardian diary; and
    • Proportion of patients with resolution of hypsarrhythmia or significant abnormality compatible with IS after 14 days of AMZ002 treatment, as indicated by video EEG.
    Criterios de valoración exploratorios de la eficacia
    Los criterios de valoración exploratorios de la eficacia son los siguientes para los pacientes aleatorizados al grupo de vigabatrina que no responden el día 14 y que luego optan por cambiar al tratamiento con AMZ002:
    • Proporción de pacientes con ausencia de espasmos clínicos después de 14 días de tratamiento con AMZ002, según lo indicado en el diario del progenitor/tutor; y
    • Proporción de pacientes con resolución de la hipsarritmia o anomalía significativa compatible con EI después de 14 días de tratamiento con AMZ002, según lo indicado por el vídeo-EEG.
    E.5.2.1Timepoint(s) of evaluation of this end point
    -patients randomized to the vigabatrin group who are non-responders at Day 14
    -Proportion of patients with absence of clinical spasms after 14 days of AMZ002 treatment
    - Proportion of patients with resolution of hypsarrhythmia or significant abnormality compatible with IS after 14 days of AMZ002 treatment
    • Pacientes aleatorizados al grupo de vigabatrina que no responden el día 14.
    • Proporción de pacientes con ausencia de espasmos clínicos después de 14 días de tratamiento con AMZ002.
    • Proporción de pacientes con resolución de la hipsarritmia o anomalía significativa compatible con EI después de 14 días de tratamiento con AMZ002.
    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 No
    E.6.7Pharmacodynamic Yes
    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
    immunogenicity
    inmunogenicidad
    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 No
    E.8.1.1Randomised Yes
    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.8.2.4Number 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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
    United States
    Poland
    Spain
    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 end of the study (“study completion”) is defined as the date of the last protocol-specified visit/assessment (including telephone contact) for the last patient in the study.
    El final del estudio ("finalización del estudio") se define como la fecha de la última visita/evaluación especificada en el protocolo (incluido el contacto telefónico) para el último paciente del estudio.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 230
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 215
    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.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 230
    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)
    Non, Provision of treatment beyond the EoS Visit will be outside of the protocol and not provided by the Sponsor.
    No, la provisión de tratamiento más allá de la visita de la Fin del Estudio estará al margen del protocolo y no será proporcionada por el promotor.
    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 Decision2022-04-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-15
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-04-14
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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