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    Summary
    EudraCT Number:2020-002812-36
    Sponsor's Protocol Code Number:PTC743-NEU-003-FA
    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:2020-11-19
    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 number2020-002812-36
    A.3Full title of the trial
    A Randomized, Parallel-Arm, Double-Blind, Placebo-Controlled Study with Open-Label Extension to Assess the Efficacy and Safety of Vatiquinone for the Treatment of Friedreich ataxia (MOVE-FA)
    Estudio aleatorizado, de grupos paralelos, doble ciego, controlado con placebo, con extensión abierta, para evaluar la eficacia y la seguridad del vatiquinona para el tratamiento de la ataxia de Friedreich (MOVE-FA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to determine if Vatiquinone, the study drug, is safe and effective to treat a neurological condition called Friedreich ataxia
    Estudio para determinar si la Vatiquinona, medicación del estudio, es segura y efectiva para tratar la ataxia de Friedreich, una condición neurológica
    A.3.2Name or abbreviated title of the trial where available
    MOVE-FA
    A.4.1Sponsor's protocol code numberPTC743-NEU-003-FA
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04577352
    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 SponsorPTC Therapeutics, 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 supportPTC Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPTC Therapeutics, Inc.
    B.5.2Functional name of contact pointPatient Advocacy
    B.5.3 Address:
    B.5.3.1Street Address100 Corporate Court
    B.5.3.2Town/ citySouth Plainfield
    B.5.3.3Post codeNJ 07080
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1 866-282-5873
    B.5.6E-mailmedinfo@ptcbio.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 nameVatiquinone
    D.3.2Product code PTC743
    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 INNVATIQUINONE
    D.3.9.1CAS number 1213269-98-7
    D.3.9.2Current sponsor codePTC743
    D.3.9.3Other descriptive namealpha-tocotrienolquinone
    D.3.9.4EV Substance CodeSUB188275
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 placeboCapsule
    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
    Friedreich Ataxia (FA)
    Ataxia de Friedreich (MOVE-FA)
    E.1.1.1Medical condition in easily understood language
    Friedreich ataxia is an autosomal recessive, neurodegenerative disease that primarily affects the nervous system and heart.
    La ataxia de Friedreich (MOVE-FA) es una enfermedad neurodegenerativa autosómica recesiva que afecta principalmente al sistema nervioso y al corazón.
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10017374
    E.1.2Term Friedreich's ataxia
    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
    The primary objective of the study is to evaluate the efficacy (using the modified Friedreich Ataxia Rating Scale [mFARS]) and safety of vatiquinone in subjects with FA.
    El objetivo principal del estudio es evaluar la eficacia (utilizando la Escala de puntuación modificada de ataxia de Friedreich [modified Friedreich Ataxia Rating Scale, mFARS]) y la seguridad de la vatiquinona en sujetos con ataxia de Friedreich (AF).
    E.2.2Secondary objectives of the trial
    • Demonstrate the effects of vatiquinone on activities of daily living as assessed by the Friedreich Ataxia Rating Scale Activities of Daily Living (FARS-ADL) scale
    • Demonstrate the effects of vatiquinone on ambulation as assessed by the 1-minute walk test (1MWT)
    • Demonstrate the effects of vatiquinone on falls as assessed by a fall log
    • Demostrar los efectos de la vatiquinona sobre las actividades de la vida diaria según la evaluación de la escala de actividades de la vida diaria de la escala de evaluación de la AF (FA Rating Scale Activities of Daily Living, FARS-ADL).
    • Demostrar los efectos del vatiquinona en la ambulación evaluada mediante la prueba de marcha de 1 minuto (1-minute walk test, 1MWT).
    • Demostrar los efectos de la vatiquinona sobre las caídas evaluados mediante un registro de caídas
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. mFARS ≥20 to ≤70 at baseline

    2. Minimum age 7 years at the time of Screening Visit

    3. Must be able to ambulate at least 10 feet in one minute with or without assistance (non-wheelchair)

    4. Friedreich ataxia diagnosis (homozygous for GAA repeat expansion in intron-1 of FXN gene), confirmed by clinical testing

    5. Consent to comply with study procedures. For subjects under the age of 18 (or age of consent), parent(s)/legal guardian(s) of the subject must agree to comply with the requirements of the study, including the need for frequent and prolonged follow-up; parent(s)/legal guardian(s) with custody of the subject must give their consent for subject to enroll in the study.

    6. Difference in the mFARS between screening and baseline of no more than 4 points
    o If the subject is taking prohibited medications (see exclusion criteria)
    at Screening, this difference is to be assessed between the
    post-discontinuation mFARS and the Baseline mFARS.

    7. Able to abstain from anticoagulants and any aspirin (including 81 mg) for 30 days prior to the Baseline Visit and for the duration of the study

    8. Ability to abstain from potent cytochrome P450 (CYP) 3A4 inducers/inhibitors (eg, ketoconazole, rifampin, St. John’s wort, grapefruit juice) for at least 4 weeks prior to enrollment

    9. Ability to swallow capsules

    10. Males and females of childbearing potential must be willing to use an effective method of contraception as defined in protocol Section 7.5.10 from the time consent is signed until 30 days after treatment discontinuation
    1. mFARS ≥20 a ≤70 al inicio
    2. Edad mínima de 7 años en el momento de la visita de selección
    3. Debe ser capaz de caminar como mínimo 10 pies (unos 3 metros) en un minuto con o sin ayuda (sin silla de ruedas).
    4. Diagnóstico de ataxia de Friedreich (homocigotos para la expansión repetida de guanina-adenina-adenina [GAA] en el intrón-1 del gen de la frataxina), confirmado mediante pruebas genéticas clínicas.
    5. Consentimiento para cumplir con los procedimientos del estudio. En el caso de los pacientes menores de 18 años (o edad del consentimiento), los progenitores/tutor(es) legal(es) del paciente deben aceptar cumplir con los requisitos del estudio, incluida la necesidad de un seguimiento frecuente y prolongado; el/los progenitor(es)/tutor(es) legal(es) con custodia del paciente debe(n) dar su consentimiento para que el paciente se inscriba en el estudio.
    6. Diferencia en la mFARS entre la selección y el inicio de no más de 4 puntos
    o Si el sujeto está tomando medicamentos prohibidos (véanse los criterios de exclusión) en la selección, esta diferencia se evaluará entre la mFARS después de la interrupción y la mFARS inicial.
    7. Capacidad para abstenerse de tomar anticoagulantes y de cualquier aspirina (incluyendo 81 mg) durante 30 días antes de la visita inicial y durante todo el estudio.
    8. Capacidad para abstenerse de tomar inductores/inhibidores potentes del citocromo P450 (CYP) 3A4 (p. ej., ketoconazol, rifampicina, hierba de San Juan, zumo de pomelo) durante al menos 4 semanas antes de la inscripción.
    9. Capacidad para tragar cápsulas
    10. Los hombres y las mujeres en edad fértil deben estar dispuestos a utilizar un método anticonceptivo eficaz (p. ej., implantes, inyectables, parche transdérmico, anticonceptivos orales, anticonceptivos orales combinados, métodos de barrera y dispositivos intrauterinos) desde el momento de la firma del consentimiento hasta 30 días después de la interrupción del tratamiento. Nota: Si no se usan otros métodos anticonceptivos, es necesario utilizar métodos de doble barrera.
    E.4Principal exclusion criteria
    1. Individuals with clinical diagnosis of FA who have point mutations or deletions or other non-GAA expansion mutations

    2. Previous treatment with vatiquinone or allergy to vatiquinone, sesame oil, gelatin (bovine and/or porcine), titanium dioxide, or red iron oxide

    3. Ejection fraction <50%

    4. Uncontrolled diabetes (HbA1c >7.0%) at the time of screening

    5. Has current suicidal ideation or suicidal behavior based on Columbia-Suicide Severity Rating Scale (C-SSRS) at screening or baseline

    6. Pregnant or lactating subjects or those sexually active subjects who are unwilling to comply with proper birth control methods; females of childbearing potential must have a negative pregnancy test at Screening and during the Baseline Visit

    7. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2 x ULN at time of screening

    8. INR ≥1.5 x ULN at time of screening or clinically significant (CS) bleeding, as determined by the investigator

    9. Serum creatinine ≥1.5 x ULN at time of screening

    10. Comorbidities that may confound study results (eg, fat malabsorption syndrome, other mitochondrial disorder) in the opinion of the investigator

    11. Participation in any other interventional clinical trial or received any investigational drug in any other clinical trial within 60 days prior to the Baseline Visit. Subjects may be rescreened after the exclusionary period of 60 days has passed.

    12. Concomitant use of CoQ10, vitamin E, idebenone, or any other non-approved medication for FA within 30 days prior to the Screening Visit. These prohibited medications can be discontinued at the Screening Visit; if this is the case, the mFARS assessment must be repeated to confirm inclusion eligibility after a minimum of 30 days post-discontinuation and there must be no more than a 4-point difference in mFARS assessed from the Post-Discontinuation Visit to the Baseline Visit.
    1. Personas con diagnóstico clínico de AF que tengan mutaciones puntuales, deleciones u otras mutaciones en la expansión sin GAA.
    2. Tratamiento previo con vatiquinona o alergia a vatiquinona, aceite de sésamo, gelatina (bovina y/o porcina), dióxido de titanio u óxido de hierro rojo
    3. Fracción de eyección <50 %
    4. Diabetes no controlada (Hba1c HH>7,0 %) en el momento de la selección.
    5. Tener ideas suicidas o conductas suicidas actuales según la escala Columbia para evaluar el riesgo de suicidio (Columbia-Suicide Severity Rating Scale, C-SSRS) en la selección o al inicio.
    6. Pacientes embarazadas o en periodo de lactancia o aquellos sexualmente activos que no estén dispuestos a cumplir los métodos anticonceptivos adecuados; las mujeres en edad fértil deben dar negativo en una prueba de embarazo en la selección y durante la visita inicial.
    7. Aspartato aminotransferasa o alanina aminotransferasa ≥2 veces el límite superior de la normalidad (LSN) en el momento de la selección.
    8. Índice internacional normalizado ≥1,5 x LSN en el momento de la selección o hemorragia clínicamente significativa, según lo determine el investigador.
    9. Creatinina sérica ≥1,5 x LSN en el momento de la selección.
    10. Comorbilidades que pueden confundir los resultados del estudio (p. ej., síndrome de malabsorción de grasa, otro trastorno mitocondrial) en opinión del investigador.
    11. Participación en cualquier otro ensayo clínico intervencionista o haber recibido algún fármaco en investigación en cualquier otro ensayo clínico en los 60 días previos a la visita inicial. Los pacientes pueden volver a ser seleccionados después de haber pasado el periodo de exclusión de 60 días.
    12. Uso concomitante de CoQ10, vitamina E o idebenona, o cualquier otro medicamento no aprobado para la AF en los 30 días previos a la visita de selección. Estos medicamentos prohibidos pueden interrumpirse en la visita de selección; si este es el caso, se debe repetir la evaluación mFARS para confirmar la aptitud para la inclusión después de un mínimo de 30 días después de la interrupción, y no debe haber más de una diferencia de 4 puntos en la mFARS evaluada desde la visita posterior a la interrupción hasta la visita inicial.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the change from baseline in the modified Friedreich Ataxia Rating Scale (mFARS) in the mITT population at Week 72.
    El Criterio principal de valoración del estudio será el cambio con respecto al inicio en la mFARS en la semana 72.
    E.5.1.1Timepoint(s) of evaluation of this end point
    A completer analysis will be performed for all subjects who took medication till the end of double-blind period as specified by the protocol and have mFARS score at Week 72 visit.
    Se realizará un análisis completo para todos los sujetos que tomaron medicación hasta el final del período doble ciego según lo especificado por el protocolo y que tengan una puntuación mFARS en la visita de la semana 72.
    E.5.2Secondary end point(s)
    Secondary endpoints will include change in baseline in the following assessments at Week 72.
    • FARS-ADL scale (key secondary endpoint)
    • 1MWT
    • Fall log
    Los criterios de valoración secundarios incluirán el cambio desde el inicio en las siguientes evaluaciones en la semana 72:
    • Escala FARS-ADL (criterio de valoración secundario clave)
    • 1MWT
    • Registro de caídas
    E.5.2.1Timepoint(s) of evaluation of this end point
    Comparisons between treatment groups for change from baseline in FARS-ADL scale, one minute timed walk, MFIS score, EQ-5D-5L, and Upright Stability subscale of the mFARS to Week 72 will be analyzed using the same model as the primary efficacy variable by using its respective baseline and age as covariates. Summary statistics will be provided for total score at each visit as well as change from baseline at each visit.

    A summary of the number of falls will be presented, and the number of falls over time will be compared between the two treatment groups.
    Las comparaciones entre los grupos de tratamiento para el cambio desde el inicio en la escala FARS-ADL, caminata cronometrada de un minuto, puntaje MFIS, EQ-5D-5L y subescala de estabilidad vertical de mFARS hasta la semana 72 se analizarán utilizando el mismo modelo como variable de eficacia primaria utilizando su respectiva línea de base y edad como covariables. Se proporcionarán estadísticas resumidas para la puntuación total en cada visita, así como el cambio con respecto al valor inicial en cada visita.

    Se presentará un resumen del número de caídas y el número de caídas a lo largo del tiempo se comparará entre los dos grupos 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 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 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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Study with Open-Label Extension
    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 EEA4
    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
    Brazil
    Canada
    France
    Germany
    Italy
    Spain
    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
    LVLS
    ÙVÙS
    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 months3
    E.8.9.1In the Member State concerned days7
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days9
    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: 90
    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: 30
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 60
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 36
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 126
    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)
    Subjects who complete the study may have the option to enter an open-label expanded access program to continue receiving vatiquinone.
    Los sujetos que completen el estudio pueden tener la opción de ingresar a un programa de acceso ampliado abierto para continuar recibiendo vatiquinona.
    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 Decision2021-06-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-19
    P. End of Trial
    P.End of Trial StatusOngoing
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