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    Summary
    EudraCT Number:2017-000748-16
    Sponsor's Protocol Code Number:MT-2-01
    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:2017-07-04
    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 number2017-000748-16
    A.3Full title of the trial
    A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTINATIONAL, MULTICENTER STUDY WITH OPEN-LABEL TREATMENT EXTENSION TO ASSESS THE EFFECT OF MIN-102 ON THE PROGRESSION OF ADRENOMYELONEUROPATHY IN MALE PATIENTS WITH X-LINKED ADRENOLEUKODYSTROPHY
    ESTUDIO MULTINACIONAL, MULTICÉNTRICO, ALEATORIZADO, DOBLE CIEGO Y CONTROLADO CON PLACEBO CON UNA EXTENSIÓN DEL TRATAMIENTO ABIERTO PARA EVALUAR EL EFECTO DE MIN-102 EN LA PROGRESIÓN DE LA ADRENOMIELONEUROPATÍA EN VARONES CON ADRENOLEUCODISTROFIA LIGADA AL CROMOSOMA X
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate effect of MIN-102 compared to Placebo after 96 weeks of randomized, double-blind Treatment followed by open-label extension study to evaluate effect of long term treatment with MIN-102 on the progression of adrenomyeloneuropathy (AMN) in male patients
    Estudio para evaluar el efecto de MIN-102 comparado con placebo tras 96 semanas de tratamiento aleatorizado, doble ciego seguido de un estudio de extensión abierto para evaluar el efecto del tratamiento a largo plazo con MIN-102e n la progresión de la adrenomieloneuropatía en pacientes varones
    A.3.2Name or abbreviated title of the trial where available
    ADVANCE
    ADVANCE
    A.4.1Sponsor's protocol code numberMT-2-01
    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 SponsorMinoryx Therapeutics S.L.
    B.1.3.4CountrySpain
    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 supportMinoryx Therapeutics S.L.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMinoryx Therapeutics S.L.
    B.5.2Functional name of contact pointSílvia Pascual
    B.5.3 Address:
    B.5.3.1Street AddressAv. Ernest Lluch 32, TCM3
    B.5.3.2Town/ cityMataró (Barcelona)
    B.5.3.3Post code08302
    B.5.3.4CountrySpain
    B.5.4Telephone number034935441446
    B.5.5Fax number034930160119
    B.5.6E-mailspascual@minoryx.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/16/1770
    D.3 Description of the IMP
    D.3.1Product name5-[4-[2-(5-(1-hydroxyethyl)-2-pyridinyl)ethoxy]benzyl]-2,4-thiazolidinedione hydrochloride
    D.3.2Product code MIN-102
    D.3.4Pharmaceutical form Oral suspension
    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 INN5-[4-[2-(5-(1-hydroxyethyl)-2-pyridinyl)ethoxy]benzyl]-2,4-thiazolidinedione hydrochloride
    D.3.9.1CAS number 146062-44-4
    D.3.9.2Current sponsor codeMIN-102
    D.3.9.4EV Substance CodeSUB16466MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 placeboOral suspension
    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
    ADRENOMYELONEUROPATHY IN MALE PATIENTS WITH X-LINKED ADRENOLEUKODYSTROPHY
    ADRENOMIELONEUROPATÍA EN VARONES CON ADRENOLEUCODISTROFIA LIGADA AL CROMOSOMA X
    E.1.1.1Medical condition in easily understood language
    ADRENOMYELONEUROPATHY
    ADRENOMIELONEUROPATÍA
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Main Study:
    Efficacy of MIN-102 on the progression of adrenomyeloneuropathy (AMN) in male patients as determined by the change from baseline in Six-Minute Walk Test (6MWT) compared with placebo after 96 weeks of treatment.

    Extension Study:
    To assess the safety and tolerability of MIN-102 upon long-term treatment.
    Estudio principal:
    Eficacia de MIN-102 sobre la progresión de la adrenomieloneuropatía (AMN) en varones de acuerdo con el cambio con respecto a los valores iniciales en la prueba de marcha de 6 minutos (6MWT) en comparación con placebo tras 96 semanas de tratamiento.
    Estudio de extension:
    Evaluar la seguridad y tolerabilidad de MIN-102 con el tratamiento a largo plazo
    E.2.2Secondary objectives of the trial
    Main Study:
    Efficacy objectives: To evaluate the effects of MIN-102 after 96 weeks of treatment on:
    • Change from baseline in body sway amplitude
    • Comprehensive clinical rating scales (SSPROM and EDSS)
    • Clinician and patient global impression of symptom severity and change
    • Muscle strength
    • Quality of life
    • Incidence of cerebral inflammatory lesions.
    Safety objectives: To evaluate the safety and tolerability of MIN-102 compared with placebo
    Exploratory objectives- To evaluate the effects of MIN-102 on various biochemical markers in plasma and cerebrospinal fluid (CSF), and spinal cord imaging parameters.

    Extension Study:
    To evaluate the long-term effects of MIN-102 on:
    • Change from baseline in 6MWT and body sway
    • Comprehensive clinical rating scales (SSPROM and EDSS)
    • Quality of life
    • Incidence of cerebral inflammatory lesions.
    Exploratory objectives- To assess the long-term effects of MIN-102 on various biochemical markers in plasma.
    Estudio principal:Objetivos eficacia: Evaluar efectos de MIN-102 tras 96 semanas de tratam. sobre: cambio respecto a valores iniciales en amplitud de balanceo del cuerpo;escalas puntuación clínica exhaustiva (SSPROM y EDSS);impresión global médico y paciente sobre intensidad y cambio de síntomas;fuerza muscular; calidad de vida;incidencia lesiones cerebrales inflamatorias.Objetivos seguridad.Evaluar seguridad y tolerabilidad de MIN-102 en comparac con placebo.Objetivos exploratorios.Evaluar efectos de MIN-102 sobre varios marcadores bioquím. en plasma y líquido cefalorraquídeo(LCR), y parámetros de obtención imágenes de méd. espinal.Estudio extension:Evaluar efectos a largo plazo de MIN-102 sobre:cambio con resp. a valores iniciales en prueba 6MWT y balanceo cuerpo;escalas puntuación clínica exhaustiva (SSPROM y EDSS);calidad vida;incidencia lesiones cerebrales inflamatorias.Objetivos exploratorios:Evaluar efectos a largo plazo de MIN-102 sobre varios marcadores bioquímicos en plasma.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Optional CSF Sampling Sub-Study (integral part of Protocol Version 1.0 dated 26 Apr 2017)
    Objective: To evaluate the effects of MIN-102 on various biochemical markers in plasma and cerebrospinal fluid (CSF).

    Optional Spinal Cord MRI scan Sub-study (integral part of Protocol Version 1.0 dated 26 Apr 2017)
    Objective: To evaluate the effects of MIN-102 on spinal cord imaging parameters.
    E.3Principal inclusion criteria
    Main Study:
    1. Male patients aged ≥18 to ≤65 years.
    2. Diagnosis of ALD based on elevated very long-chain fatty acids (VLCFA) and genetic testing
    3. Clinical evidence of spinal cord involvement, with an EDSS score between 2 and 6
    4. Ability to walk for 6 minutes, without or with rest, with usual walking aids (cane or walker)
    5. Ability to stand on a force plate with closed eyes and with feet apart for a minimum of 20 seconds
    6. Either a normal brain MRI or a type-3 pattern MRI abnormality in which the abnormality is considered to represent the centripetal extension of the distal axonopathy
    7. Normal adrenal function or appropriate steroid replacement if adrenal insufficiency is present.

    Extension Study:
    1. Consent to participate in the extension study part
    2. Completion of the entire 96-weeks double-blind period of the study (Part 1) and consent to participate in the extension study part
    3. Normal adrenal function or appropriate steroid replacement
    Estudio principal:
    1.Varones de ≥ 18 a ≤ 65 años de edad.
    2.Tener un diagnóstico de ALD basado en una elevación de los ácidos grasos de cadena muy larga (AGCML) y pruebas genéticas.
    3.Tener pruebas clínicas de afectación de la médula espinal, con una puntuación EDSS entre 2 y 6.
    4.Capacidad para caminar durante 6 minutos, sin o con descanso, con los dispositivos de ayuda para caminar habituales (bastón o andador).
    5.Capacidad para permanecer de pie sobre una plataforma de fuerza con los ojos cerrados y con los pies separados durante un mínimo de 20 segundos
    6.Tener una RM del cerebro normal o bien una anomalía en la RM de patrón tipo 3 en la que se considere que la anomalía representa la extensión centrípeta de la axonopatía distal
    7.Tener una función suprarrenal normal o reemplazo de esteroides apropiado si existe una insuficiencia suprarrenal.
    Estudio de esxtensión:
    1.Aportar el consentimiento informado por escrito para participar en la parte del estudio de extension
    2.Finalizar el periodo entero doble ciego de 96 semanas del estudio (parte 1).
    3.función suprarrenal normal o reemplazo de esteroides apropiado
    E.4Principal exclusion criteria
    Main Study & Extension Study:
    1. Any other chronic neurological disease with signs of spastic paraplegia
    2. Known type 1 or type 2 diabetes.
    3. Known intolerance to pioglitazone or any other thiazolidinedione.
    4. Previous or current use of honokiol, pioglitazone or other thiazolidinediones, biotin (MD-1003), unstable dose of Lorenzo's oil
    5. Current treatment with immunosuppressant medication, except for corticosteroids.
    6. Previous or current history of cancer, bone marrow transplantation, Congestive heart failure, significant liver and renal disorders, anemia, pulmonary or cardiac diseases, Cognitive or behavioral abnormalities, alcohol/drug abuse etc.
    Estudio principal y de extension:
    1.Cualquier otra enfermedad neurológica crónica con signos de paraplejía espástica.
    2.Diabetes conocida de tipo 1 o tipo 2.
    3. Intolerancia conocida a la pioglitazona o a cualquier otra tiazolidinediona
    4.Pacientes que estén tomando o hayan tomado honokiol, pioglitazona u otras tiazolidinedionas, biotina (MD-1003), dosis no estable de aceite de Lorenzo.
    5.Tratamiento actual con inmunodepresores, excepto los corticoesteroides
    6.Antecedentes previos o actuales de cancer, trasplante de médula ósea, insuficiencia cardíaca congestiva, enfermedad hepatica o renal significativa, anemia, nefermedad pulmonary o cardiac, Anomalías cognitivas o conductuales, alcoholismo y/o drogadicción, etc
    E.5 End points
    E.5.1Primary end point(s)
    Main Study:
    1. Efficacy: Change from baseline to week 96 in the total walking distance in the 6MWT

    Extension Study:
    1. Long-term safety and tolerability assessed in terms of AE, SAE, SUSARs, Vitals signs, ECG, Clinical Laboratory tests
    Estudio principal:
    1.Eficacia: cambio con respecto a los valores iniciales hasta la semana 96 en la distancia total recorrida en la prueba 6MWT

    Estudio de extension:
    1. Seguridad y tolerabilidad a largo plazo de MIN-102, que se evaluará en términos de AA, AAG y SRAGI, constantes vitales, análisis clínicos de laboratorio
    E.5.1.1Timepoint(s) of evaluation of this end point
    During treatment period
    Durante el periodo de tratamiento
    E.5.2Secondary end point(s)
    Main Study:
    1. Changes from baseline to week 96 in the following:
    • Body sway amplitude
    • Comprehensive clinical rating scales (SSPROM, EDSS)
    • Clinician and patient global impression Scales (CGI-S, CGI-I, PGI-I)
    • Dynamometry
    • Quality of Life Assessments (EQ-5D-5L, MSWS-12, Qualiveen-SF and IIEF)
    • Cerebral MRI (incidence of inflammatory lesions)
    2. Safety : Assessed in terms of AE, SAE, SUSARs, Vitals signs, ECG, Clinical Laboratory tests

    Extension Study:
    Changes from the baseline to the last scheduled on-study assessment for the following variables:
    • 6MWT
    • Body sway amplitude
    • Comprehensive clinical rating scales (SSPROM, EDSS)
    • Quality of Life Assessments (EQ-5D-5L, MSWS-12, Qualiveen-SF and IIEF)
    • Cerebral MRI (incidence of inflammatory lesions)
    Estudio principal:
    1.Cambios con respecto a los valores iniciales hasta la semana 96 en:
    -La amplitud de balanceo del cuerpo
    -Las escalas de puntuación clínica exhaustiva (SSPROM y EDSS).
    - Escalas para la impresión global del médico y el paciente (CGI-S, CGI-I, PGI-I)
    -Cuestionarios de calidad de vida (EQ-5D-5L, MSWS-12, Qualiveen-SF y
    IIEF)
    -RM del cerebro (incidencia de lesiones cerebrales inflamatorias).
    2. Seguridad: Seguridad
    Se evaluará la seguridad en términos de de AA, AAG y SRAGI, constantes vitales, análisis clínicos de laboratorio.
    Estudio de extension:
    Cambios con respecto a los valores iniciales de la parte 2 (V6) hasta la última evaluación durante el estudio programada para las siguientes variables:
    -6MWT
    -La amplitud de balanceo del cuerpo
    - Escalas de puntuación clínica exhaustiva (SSPROM y EDSS);
    - Evaluaciones de la calidad de vida (EQ-5D-5L, MSWS-12, Qualiveen-SF y IIEF).
    - RM del cerebro (incidencia de lesiones cerebrales inflamatorias).
    E.5.2.1Timepoint(s) of evaluation of this end point
    During treatment period
    Durante el periodo de tratamiento
    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 Yes
    E.6.6Pharmacokinetic Yes
    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 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) 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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    El estudio principal es aleatorizado, controlado, doble ciego y el estudio de extensión es abierto
    Main Study is Randomized, Controlled, Double-Blind and Extension Study is Open-Label
    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 trial2
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    France
    Germany
    Hungary
    Italy
    Netherlands
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    Main Study: LVLS (expected duration of trial is 3 years after which Clinical Study Report (CSR) will be written)

    Extension Study: LVLS (expected duration of trial cannot be estimated since it will be for unlimited time in principle)
    Estudio principal: Última Visita del úlltimo Sujeto (la duración esperada del ensayo es de 3 años tras lo cual se escribirá el Informe Final del Ensayo

    Estudio de extension: Última Visita del úlltimo Sujeto (la duración del ensayo no puede estimarse ya que en principio será por un tiempo ilimitado)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    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: 105
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    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 88
    F.4.2.2In the whole clinical trial 105
    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)
    Extension study is intended to be continued for unlimited time until one of the termination criteria according to the protocol is met
    Se pretende que el studio de extension continue por un tiempo ilimitado hasta que uno de los criterios de terminación se cumpla de acuerdo con el protocolo
    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 Decision2017-08-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-07-28
    P. End of Trial
    P.End of Trial StatusOngoing
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