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    Summary
    EudraCT Number:2019-004498-18
    Sponsor's Protocol Code Number:HUB-NEU-2019-01
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-12-20
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2019-004498-18
    A.3Full title of the trial
    EFFICACY AND SAFETY CLINICAL TRIAL WITH EFAVIRENZ IN PATIENTS DIAGNOSED WITH ADULT NIEMANN-PICK TYPE C WITH COGNITIVE IMPAIRMENT
    ENSAYO CLÍNICO DE EFICACIA Y SEGURIDAD DE EFAVIRENZ EN PACIENTES DIAGNOSTICADOS DE NIEMANN-PICK C DEL ADULTO CON DETERIORO COGNITIVO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to test efficacy and safety of efavirenz in patients with Niemann-Pick C disorder with cognitive impairment
    Ensayo Clínico para evaluar la eficàcia y Seguridad del efavirenz en pacientes con la enfermedad de Niemann pick tipo C con deterioro cognitivo
    A.4.1Sponsor's protocol code numberHUB-NEU-2019-01
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorDr. Jordi Gascón / Dra. Lola Ledesma
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportFundación Española Niemann-Pick
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJordi
    B.5.2Functional name of contact pointGascón Bayarri
    B.5.3 Address:
    B.5.3.1Street AddressCarrer de la Feixa Llarga, s/n
    B.5.3.2Town/ cityL'Hospitalet de Llobregat - Barcelona
    B.5.3.3Post code08907
    B.5.3.4CountrySpain
    B.5.4Telephone number0034932607628
    B.5.6E-mailjordigneuro@bellvitgehospital.cat
    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 SUSTIVA efavirenz 100 mg
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameEfavirenz
    D.3.4Pharmaceutical form Capsule
    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 INNEfavirenz
    D.3.9.3Other descriptive nameEFAVIRENZ
    D.3.9.4EV Substance CodeSUB06463MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number100 to 200
    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
    Niemann Pick tipo C (NPC)
    Niemann Pick C type (NPC)
    E.1.1.1Medical condition in easily understood language
    Niemann Pick C type (NPC) is a genetic neurological disorder.
    Niemann Pick tipo C (NPC) es una patología genética neurodegenerativa.
    E.1.1.2Therapeutic area Body processes [G] - Genetic Phenomena [G05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10029403
    E.1.2Term Niemann-Pick disease
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of EFV 100 mg/day oral use, added to usual treatment, in patients diagnosed with late NPC of adult or juvenile with cognitive impairment.
    Evaluar la eficacia de EFV 100 mg/d por v.o., añadido al tratamiento habitual, en pacientes diagnosticados de NPC del adulto o juvenil tardía con deterioro cognitivo.
    E.2.2Secondary objectives of the trial
    CLINICAL EFFICACY ASSESSMENT:
    - Clinical:
    Neurological. To evaluate change in the questionnaires / scales.
    Neuropsychological. To evaluate change in the questionnaires / scales.
    - Biological:
    To evaluate change in image and functional biomarkers related to NPC.
    To evaluate change in NPC-related biochemical biomarkers.
    SECURITY ASSESMENT CRITERIA:
    -To evaluate the safety of EFV in patients diagnosed with NPC in adults with cognitive impairment.
    OBJETIVOS DE EFICACIA:
    - Clínicos:
    Neurológicos. Evaluar el cambio en los siguientes cuestionarios / escalas.
    Neuropsicológicos. Evaluar el cambio en los siguientes cuestionarios / escalas.

    - Biológicos:
    Evaluar el cambio en biomarcadores de imagen y funcionales relacionados con NPC.
    Evaluar el cambio en biomarcadores bioquímicos relacionados con NPC.

    OBJETIVOS DE SEGURIDAD
    -Evaluar la seguridad de EFV en pacientes diagnosticados de NPC del adulto con deterioro cognitivo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Patients ≥14 years.
    -Both genders.
    -Diagnosis of adult NPC based on a genetic study with 2 genetic changes related to the disease.
    or
    1 genetic change related to the disease and a positive Filipina stain and a positive biomarker.
    - Presence of light-moderate cognitive impairment with scores on the global Clinical Dementia Rating (CDR) ≤2 points and/or on the CDR-SoB ≤12 points.
    -According to the researcher's criteria, patient has the capacity to understand the nature of the study and its relevant information, as well as to make the decision to participate, understanding the possible risks.
    - Availability of a caregiver who lives with the patient more than 5 days a week, who can inform the patient's clinical situation, who understands the nature of the study and its risks, and who can sign the informed consent.
    - Proficiency in the Spanish language (language of the cognitive tests to be performed).
    -Sufficient visual and auditory acuity to understand the explanations given and the neuropsychological tests.
    - Schooling of minimum 8 years.
    - Being on miglustat treatment (the only treatment indicated) with a stable dose in the last 3 months.
    - In the case of women of childbearing potential (period between menarche and menopause), must have negative pregnancy test.
    - For women of childbearing potential (period between menarche and menopause), commitment to the use of barrier contraceptives in combination with other contraceptive methods (e.g. oral contraceptives or other hormonal contraceptives) or commitment to sexual abstinence, at least until 12 weeks after the last drug dose.
    - In the case of males, commitment to use barrier contraceptives (condoms) at least until 12 weeks after the last drug dose.
    - Informed consent is given by the patient.
    -Pacientes ≥14 años.
    -Ambos sexos.
    -Diagnosticado de NPC del adulto basado en un estudio genético con 2 cambios genéticos relacionados con la enfermedad
    o
    1 cambio genético relacionados con la enfermedad y una tinción de Filipina positiva y un biomarcador positivo.
    -Presencia de un deterioro cognitivo ligero-moderado con puntuaciones en el Clinical Dementia Rating (CDR) global ≤2 puntos y/o en el CDR-SoB ≤12 puntos.
    -Según criterio del investigador, el paciente tiene capacidad para comprender la naturaleza del estudio y su información relevante, así como para tomar la decisión de participar comprendiendo los posibles riesgos.
    - Disponibilidad de un cuidador que conviva con el paciente más de 5 días a la semana, que pueda informar de la situación clínica del paciente, que comprenda la naturaleza del estudio y sus riesgos y que pueda firmar el consentimiento informado.
    - Dominio del idioma castellano (idioma de las pruebas cognitivas a realizar).
    -Agudeza visual y auditiva suficiente para comprender las explicaciones dadas y las pruebas neuropsicológicss.
    - Escolarización de 8 años mínimo.
    - Estar en tratamiento con miglustat (único tratamiento indicado) con una dosis estable en los 3 últimos meses.
    - En el caso de las mujeres en edad fértil (periodo entre menarquía y menopausia), prueba de embarazo negativa.
    - En el caso de las mujeres en edad fértil (periodo entre menarquía y menopausia), compromiso a la utilización de anticonceptivos de barrera en combinación con otros métodos anticonceptivos (p. ej., anticonceptivos orales u otros anticonceptivos hormonales) o compromiso de abstinencia sexual, al menos hasta 12 semanas después de la última dosis de fármaco.
    - En el caso de varones, compromiso de utilizar anticonceptivos de barrera (preservativos) al menos hasta 12 semanas después de la última dosis de fármaco.
    - El paciente otorga el consentimiento informado.
    E.4Principal exclusion criteria
    - Any sign or suspicion of a diagnosis other than NPC disease.
    - Presence of infections that affect brain function.
    - History of severe head injury.
    - Severe psychiatric history: bipolar disorder, schizophrenia, major depressive disorder.
    - Risk of suicide, depending on the caregiver or investigator.
    - Substance abuse or dependence.
    - Presence of cerebral vascular disease which, in the opinion of the investigator, may explain the cognitive clinic.
    - Inability to tolerate studies.
    - Stage IV chronic nephropathy.
    - Chronic liver failure, or elevation of AST or ALT ≥3 times the upper limits of normality.
    - Chronic hepatitis B or C virus infection (HBV or HCV).
    - Patients with systemic immunosuppression.
    - Non-stable epilepsy (according to the Investigator's criteria) during the last 3 months.
    - History of an oncological disease that is not considered stable or cured (as a rule, patients with less than 5 years of absence of treatment should not be recruited).
    - Severe dementia that prevents the performance of tests and cognitive assessment.
    - History of allergy to EFV.
    - The use of anticoagulants do not exclude the subject off the study, but it does exclude the option of performing lumbar puncture.
    - Cualquier signo o sospecha de un diagnóstico distinto al de enfermedad de NPC.
    - Presencia de infecciones que afecten la función cerebral.
    - Antecedentes de traumatismos craneales graves.
    - Antecedentes psiquiátricos graves: trastorno bipolar, esquizofrenia, trastorno depresivo mayor.
    - Riesgo de suicidio, según el cuidador o el investigador.
    - Abuso o dependencia de substancias.
    - Presencia de enfermedad vascular cerebral que, en opinión del investigador, pueda explicar la clínica cognitiva.
    - Incapacidad para tolerar los estudios realizados.
    - Nefropatía crónica en estadio IV.
    - Insuficiencia hepática crónica, o elevación de la AST o ALT ≥3 veces el límites superior de la normalidad.
    - Infección crónica por el virus de la hepatitis B o C (VHB o VHC).
    - Pacientes con inmunosupresión sistémica.
    - Epilepsia no estable (según criterios del Investigador) durante los últimos 3 meses.
    - Antecedentes de una enfermedad oncológica no considerada estable o curada (por norma se evitará reclutar pacientes con menos de 5 años de ausencia de tratamientos).
    - Demencia severa que impida la realización de las pruebas y la evaluación cognitiva.
    - Antecedentes de alergia a EFV.
    - El uso de anticoagulantes no excluye del estudio, pero sí de la opción de realizar la punción lumbar.
    E.5 End points
    E.5.1Primary end point(s)
    The main study variable is the change (no worsening) in cognitive performance, at 52 weeks of treatment, evaluated by the:
    1. Clinical Scale Score Dementia Rating-Sum of Boxes (CDR-SoB);

    2. Verbal memory:
    a) Free and Cued Selective Reminding Test (FCSRT) score;

    3. Executive function:
    a) Barcelona Revised Test (TB-R): Score in the subtest of digits;
    b) Barcelona Revised Test (TB-R): Mental control subtest score;
    c) Verbal fluency score: semantic and phonetic key (CF and LF);
    d) Trail Making Test score A and B (TMT);
    e) Stroop Color and Word Test Score (STROOP).

    The worsening on the CDR-SoB Scale is defined as the INCREASE of ≥2 points, at 52 weeks of treatment, with respect to baseline.

    Impairment in verbal memory is defined as the DISMINUTION of ≥1 standard deviation (SD) in the FCSRT, at 52 weeks of treatment, from baseline.

    The worsening in executive function is defined as the DISMINUTION of ≥1 DE on ≥2 of the 5 tests applied, at 52 weeks of treatment, with respect to basal moment.

    A person is considered to be responsive to treatment (does not worsen cognitive performance) if, at the end of 52 weeks of treatment with respect to baseline, there is no worsening in at least 2 of the 3 items evaluated.
    La variable principal del estudio es el cambio (el no empeoramiento) en el rendimiento cognitivo, a las 52 semanas de tratamiento, evaluado mediante la:

    1. Puntuación en la Escala Clinical Dementia Rating-Sum of Boxes (CDR-SoB);

    2. Memoria verbal:
    a) Puntuación del Free and Cued Selective Reminding Test (FCSRT);

    3. Función ejecutiva:
    a) Test Barcelona Revisado (TB-R): Puntuación en el subtest de dígitos;
    b) Test Barcelona Revisado (TB-R): Puntuación en el subtest de control mental;
    c) Puntuación en Fluencia verbal: clave semántica i fonética (CF y LF);
    d) Puntuación del Trail Making Test A y B (TMT);
    e) Puntuación del Stroop Color and Word Test (STROOP).

    El empeoramiento en la Escala CDR-SoB se define como el AUMENTO de ≥2 puntos, a las 52 semanas de tratamiento, con respecto al momento basal.

    El empeoramiento en la memoria verbal se define como la DISMINUCIÓN de ≥1 desviación estándar (DE) en el FCSRT, a las 52 semanas de tratamiento, con respecto al momento basal.

    El empeoramiento en la función ejecutiva se define como la DISMINUCIÓN de ≥1 DE en ≥2 de los 5 tests aplicados, a las 52 semanas de tratamiento, con respecto al momento basal.

    Se considera que una persona es respondedora al tratamiento (no empeora su rendimiento cognitivo) si, al final de las 52 semanas de tratamiento respecto al momento basal, no presenta empeoramiento en mínimo 2 de los 3 ítems evaluados.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The assessment of the main variable is in week 52.
    La valoración de la variable principal es en la semana 52.
    E.5.2Secondary end point(s)
    Efficiency variables:

    1. Clinics:
    - Neurological. Assess the change in the questionnaires/scales
    - Neuropsychological (protocol used in clinical practice). In general, the average score will be determined for the questionnaires / scales described.

    2. Biological:
    - Image and functional biomarkers related to NPC (PET, RMN, abdominal ultrasound and oculography).
    - Biochemical biomarkers related to NPC

    Safety variables:
    1. Number of adverse events by severity and relation to the EFV
    2. Liver function
    Variables de eficacia:

    1. Clínicas:
    - Neurológicas. Evaluar el cambio en los cuestionarios / escales
    - Neuropsicológicas (protocolo utilizado en la práctica clínica). En general se determinará la puntuación baremada para los cuestionarios / escalas descritos.
    2. Biológicas:
    - Biomarcadores de imagen y funcionales relacionados con NPC (PET, RMN, Ecografia abdominal y oculografia)
    - Biomarcadores bioquímicos relacionados con NPC

    Variables de seguridad:
    1. Número de acontecimientos adversos según la gravedad y relación con el EFV
    2. Función hepática.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Clinical variables: Neurological and Neuropsychological at week 26 and 52.
    Biological image variables: week 26 and 52.
    Biologic of biomarkers variables: throughout the study.
    Safety variables: throughout the study.
    Clínicas: Neurológicas y Neuropsicológicas en la semana 26 y 52.
    Biológicas de imagen : semana 26 y52.
    Biológicas de biomarcadores : durante todo el estudio.
    Seguridad: durante todo el estudio.
    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 Yes
    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) Yes
    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.8.2.4Number of treatment arms in the trial1
    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 No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    Last Patient Last Visit
    Último paciente última visita
    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
    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: 1
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 1
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 10
    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 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 state11
    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)
    Patients included in the Clinical Trial will be offered the possibility of continuing treatment with EFV in a subsequent study. This extension study shall be initiated before the results of the clinical trial are known, provided that no safety problems with EFV have been observed. Therefore, patients in the study will not be forced to discontinue EFV treatment once this clinical trial is over.
    Se ofrecerá a los pacientes incluidos en el Ensayo Clínico la posibilidad de continuar el tratamiento con EFV en un estudio posterior. Este estudio de extensión se iniciará antes de conocer los resultados del ensayo clínico, siempre y cuando no se haya observado problemas de seguridad con EFV. Por lo tanto, los pacientes del estudio no se verán obligados a interrumpir el tratamiento con EFV una vez acabado el presente ensayo clínico.
    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 Decision2020-06-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-23
    P. End of Trial
    P.End of Trial StatusOngoing
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