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    Summary
    EudraCT Number:2017-002163-17
    Sponsor's Protocol Code Number:15-138
    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:2020-01-23
    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 number2017-002163-17
    A.3Full title of the trial
    A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTRE STUDY OF THE EFFICACY AND SAFETY OF NICOTINAMIDE IN PATIENTS WITH FRIEDREICHS ATAXIA.
    ENSAYO CLINICO RANDOMIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO, GRUPO PARALELOS, MULTICENTRICO PARA EVALUAR LA EFICACIA Y SEGURIDAD DE NICOTINAMIDA EN PACIENTE CON ATAXIA DE FRIEDREICH
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    MULTICENTRE STUDY OF THE EFFICACY AND SAFETY OF NICOTINAMIDE IN PATIENTS WITH FRIEDREICHS ATAXIA.
    ESTUDIO CLINICO MULTICENTRICO PARA AVALUAR LA EFICACIA Y SEGURIDAD DE NICOTINAMIDA EN PACIENTES CON ATAXIA DE FRIEDREICH
    A.3.2Name or abbreviated title of the trial where available
    NICOFA
    A.4.1Sponsor's protocol code number15-138
    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 SponsorRWTH Aachen University represented by the Rector himself, represented by the Dean of the Medical Faculty
    B.1.3.4CountryGermany
    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 supportDeutsche Forschungsgemeinschaft
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital RWTH Aachen
    B.5.2Functional name of contact pointCTC-A
    B.5.3 Address:
    B.5.3.1Street AddressPauwelsstr.30
    B.5.3.2Town/ cityAachen
    B.5.3.3Post code52074
    B.5.3.4CountryGermany
    B.5.4Telephone number004924180 80092
    B.5.5Fax number004924180 33 80092
    B.5.6E-mailctc-a@ukaachen.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 nameNicotinamide
    D.3.4Pharmaceutical form Capsule, hard
    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 INNNICOTINAMIDE
    D.3.9.1CAS number 98-92-0
    D.3.9.4EV Substance CodeSUB09246MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    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
    Ataxia de Friedreich
    E.1.1.1Medical condition in easily understood language
    Friedreich Ataxia
    Ataxia de Friedreich
    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
    To evaluate the efficacy of daily doses of nicotinamide in slowing disease progression as measured by changes in the Scale for the Assessment and Rating of Ataxia (SARA) as compared with placebo in patients with Friedreic's ataxia.
    Evaluar la eficacia de las dosis diarias de nicotinamida para ralentizar la progresión de la enfermedad, en base a los cambios en la Escala de evaluación y calificación de la ataxia (SARA) en comparación con el placebo en pacientes con ataxia de Friedreic
    E.2.2Secondary objectives of the trial
    To determine the change of secondary endpoints such as quality of life, functional motor and cognitive measures, clinician’s and patient’s global impression-change scales as well as frataxin protein level under treatment of daily doses of nicotinamide as compared with placebo in patients with Friedreich´s ataxia.
    To evaluate cognition, cardiac and spinal cord/brain measures.
    Evaluar parámetros cognitivas, cardíacas y medulares / cerebrales.
    Determinar el cambio en las variables de valoración secundarias, como calidad de vida, medidas funcionales motoras y cognitivas, escalas globales de cambio de impresión del médico y del paciente, así como el nivel de proteína frataxina, e paciente en tratamiento con dosis diarias de nicotinamida en comparación con placebo en pacientes con diagnóstico de ataxia de Friedreich.

    Evaluar parámetros cognitivos, cardíacos y medulares/cerebrales.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients must have a molecular genetic diagnosis of Friedreich ataxia with a GAA-repeat expansion on both alleles of the FXN gene and a SARA Score >7 and <28.
    2. Patients must be ≥18 and <50 years old and have a weight of at least 50kg.
    3. Written informed consent prior to study participation
    4. A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea or of childbearing potential and agrees to use of appropriate contraceptive measures.
    1. Los pacientes deben tener un diagnóstico genético molecular de ataxia de Friedreich con una expansión repetida por GAA en ambos alelos del gen FXN y un puntaje SARA> 7 y <28.
    2. Los pacientes deben tener ≥18 y <50 años y tener un peso de al menos 50 kg.
    3. Consentimiento informado por escrito antes de la participación en el estudio.
    4. Una mujer es elegible para participar, en el caso que: No sea un mujer con potencial reproductivo, es decir mujeres premenopáusicas a las que se les haya realizado una ligadura de trompas o histerectomía o mujeres posmenopáusicas es decir con 12 meses de amenorrea espontánea; o mujeres con potencial reproductivo y que acepten el usar medidas anticonceptivas apropiadas.
    E.4Principal exclusion criteria
    1. Patients with any medical condition or illness that, in the opinion of the investigator would interfere with study compliance and/or impair the patient´s ability to participate or complete the study.
    2. Any uncontrolled medical or neurological/neurodegenerative condition (other than Friedreich ataxia).
    3. Clinically significant psychiatric illness (e.g., uncontrolled major depression, schizophrenia, bipolar affective disorder) within 6 months prior to screening.
    4. Patients with significant clinical dysphagia.
    5. Hypersensitivity to nicotinamide.
    6. Patients known to be positive for human immunodeficiency virus (HIV).
    7. Patients with a significant history of substance abuse (e.g. alcohol or drug abuse) within the previous six months before enrolment.
    8. Patients with a history of severe allergies to medications.
    9. Indication of impaired liver function as shown by an abnormal liver function profile at screening (e.g., repeated values of aspartate aminotransferase [AST], alanine aminotransferase [ALT] and bilirubin ≥3 × the upper limit of normal).
    10. History of malignancy or carcinoma. The following exceptions may be made after discussion with the Sponsor:
    • Subjects with cancers in remission more than 5 years prior to screening.
    • Subjects with a history of excised or treated basal cell or squamous carcinoma.
    • Subjects with prostate cancer in situ.
    11. History or evidence of an autoimmune disorder considered clinically significant by the Investigator or requiring chronic use of systemic corticosteroids or other immunosuppressants.
    12. History of clinically significant cardiac disease (ejection fraction < 40% (normal range 50-70%), cardiac insufficiency defined as New York Heart Association (NYHA) Class >2; clinically significant congenital or acquired valvular disease; symptomatic coronary disease such as prior myocardial infarction or angina, B-type natriuretic peptide (BNP) level increase more than 2 x of the normal age- and gender dependent range; history of unstable arrhythmias, history of atrial fibrillation).
    13. The subject received an investigational drug within 30 days prior to inclusion into this study.
    14. Patients taking sodium valproate or any other known histone deacetylase inhibitor.
    15. Use of vitamin B1 (thiamine), withdrawal should be at least 3 months prior Screening.
    16. Use of vitamin B3 (nicotinamide), withdrawal should be at least 3 months prior Screening.
    17. If patients are taking idebenone or coenzyme Q10 (CoQ), this should be stable over the last three months and not changed during the study.
    18. The subject is unwilling or unable to provide written informed consent and to follow the procedures outlined in the protocol.
    19. For subjects who will undergo an MRI: Any contraindications to MRI such as, but not limited to cardiac pacemaker, implanted cardiac defibrillator, aneurysm clips, carotid artery vascular clamp, neurostimulator, implanted drug infusion devices, metal fragments or foreign objects in the eyes, skin or body, bone growth/fusion stimulator, cochlear, otologic implant, severe claustrophobia or any condition that would counterindicate an MRI scan.
    20. Patients participating in another interventional clinical trial, excluding natural history/observational studies, at start of the study or within the last 30 days before study start.
    21. The subject is mentally or legally incapacitated.
    22. Pregnant females as determined by positive [serum or urine] hCG test at Screening or prior to dosing. Participants of child-bearing age should use adequate contraception as defined in the study protocol.
    23. Lactating females.
    1. Pacientes con cualquier condición médica o enfermedad que, en opinión del investigador, interferiría con el cumplimiento del estudio y/o afectaría la capacidad del paciente para participar o completar el estudio.
    2. Cualquier condición médica o neurológica/ neurodegenerativa no controlada (que no sea la ataxia de Friedreich).
    3. Enfermedad psiquiátrica clínicamente significativa (por ejemplo, depresión mayor no controlada, esquizofrenia, trastorno afectivo bipolar) dentro de los 6 meses previos al screening.
    4. Pacientes con disfagia clínicamente significativa.
    5. Hipersensibilidad a la nicotinamida.
    6. Pacientes que se sabe son positivos para el virus de inmunodeficiencia humana (VIH).
    7. Pacientes con antecedentes importantes de abuso de sustancias (por ejemplo, abuso de alcohol o drogas) dentro de los seis meses anteriores al screening.
    8. Pacientes con antecedentes de alergias graves a medicamentos.
    9. Paciente con evidencia de una función hepática alterada detectada como un perfil hepático anormal en el screening (por ejemplo, valores repetidos de aspartato aminotransferasa [AST], alanina aminotransferasa [ALT] y bilirrubina ≥3 × el límite superior de la normalidad).
    10. Historia de malignidad o carcinoma. Se pueden hacer las siguientes excepciones después haber realizado la consulta al Promotor:
    • Sujetos con cáncer en remisión más de 5 años antes del screening.
    • Sujetos con antecedentes de carcinoma escamoso o de células basales extirpado o tratado.
    • Sujetos con cáncer de próstata in situ.
    11. Historia o evidencia de un trastorno autoinmune considerado clínicamente significativo por el investigador o que requiere el uso crónico de corticosteroides sistémicos u otros inmunosupresores.
    12. Historia de enfermedad cardíaca clínicamente significativa (fracción de eyección <40% (rango normal 50-70%), insuficiencia cardíaca definida como New York Heart Association (NYHA) Clase> 2; enfermedad valvular congénita o adquirida clínicamente significativa; enfermedad coronaria sintomática como infarto de miocardio previo o angina, péptido natriurético tipo B (BNP) incrementado más de 2 veces el rango normal según edad y el género; antecedentes de arritmias inestables, antecedentes de fibrilación auricular.
    13. El sujeto recibió un medicamento en investigación dentro de los 30 días previos a la inclusión en este estudio.
    14. Pacientes que toman valproato de sodio o cualquier otro inhibidor de histona desacetilasa conocido.
    15. Uso de vitamina B1 (tiamina), la abstinencia debe realizarse al menos 3 meses antes de la detección.
    16. Uso de vitamina B3 (nicotinamida), la retirada debe realizarse al menos 3 meses antes de la detección.
    17. Si los pacientes toman idebenona o coenzima Q10 (CoQ), esto debería ser continuo durante los últimos tres meses y no cambiar durante el estudio.
    18. El sujeto no desea o no puede dar su consentimiento informado por escrito y seguir los procedimientos descritos en el protocolo.
    19. Para los sujetos que se someterán a una resonancia magnética: cualquier contraindicación para la resonancia magnética, como, entre otros, marcapasos cardíacos, desfibrilador cardíaco implantado, pinzas de aneurisma, pinza vascular de la arteria carótida, neuroestimulador, dispositivos de infusión de fármacos implantados, fragmentos metálicos u objetos extraños en el ojos, piel o cuerpo, estimulador de crecimiento / fusión ósea, coclear, implante otológico, claustrofobia severa o cualquier condición que pueda contraindicar una resonancia magnética.
    20. Pacientes que participan en otro ensayo clínico intervencionista, excluyendo estudios de historia natural / estudios observacionales, al inicio del estudio o dentro de los últimos 30 días antes del inicio del estudio.
    21. El sujeto está mental o legalmente incapacitado.
    22. Mujeres embarazadas según lo determinado por la prueba de hCG [suero u orina] positiva en la detección o antes de la dosificación. Los participantes en edad de reproductiva deben usar un método anticonceptivo adecuado como se define en el protocolo del estudio.
    23. Mujeres en periódo de lactancia.
    E.5 End points
    E.5.1Primary end point(s)
    Change in the Scale for the Assessment and Rating of Ataxia (SARA)
    Cambio en la escala para la evaluación y calificación de la ataxia (SARA)
    E.5.1.1Timepoint(s) of evaluation of this end point
    At screening, baseline, +4 month, +8 month, +12 month, +18 month and +24 month
    En la evaluación inicial, +4 meses, +8 meses, +12 meses, +18 meses y +24 meses
    E.5.2Secondary end point(s)
    1) Progression of quality of life measures such as the `Activity of Daily Living´ (ADL) scores, `modified Friedreich ataxia rating scale´ (mFARS) and the EuroQol five dimensions questionnaire (EQ-5D)
    2) Progression of `Spinocerebellar Ataxia Functional Index´ (SCAFI) (Schmitz-Hubsch et al., 2008)
    3) Progression of `Composite Cerebellar Functional Severity´ (CCFS), which has been validated in children and adults with Friedreich ataxia (Filipovic Pierucci et al., 2015)
    4) Progression of `Inventory of Non-Ataxia Signs´ (INAS) (Jacobi et al., 2013)
    5) Up-regulation of frataxin protein level
    6) Clinician’s Global Impression-Change Scale (CGI-C)
    7) Patient’s Global Impression-Change Scale (PGI-C)
    8) Safety
    9) Progression of the `Montreal Cognitive Assessment´ (MoCA)
    10) Active modification of the FXN locus, as measured by chromatin immunoprecipitation and chromosome confirmation capture sequencing
    11) Percentual change in left ventricular mass index as measured by echocardiogram
    12) Structural and functional changes of the brain and spinal cord, measured by magnetic resonance imaging (MRI)
    1) Progresión en las medidas de calidad de vida, como los puntajes de 'Actividad de la vida diaria' (ADL), 'escala de calificación de ataxia de Friedreich modificada' (mFARS) y el cuestionario EuroQol de cinco dimensiones (EQ-5D)
    2) Progresión del índice funcional de ataxia espinocerebelosa (SCAFI) (Schmitz-Hubsch et al., 2008)
    3) Progresión de la 'Severidad funcional cerebelosa compuesta' (CCFS), que ha sido validada en niños y adultos con ataxia de Friedreich (Filipovic Pierucci et al., 2015)
    4) Progresión del 'Inventario de signos de no ataxia' (INAS) (Jacobi et al., 2013)
    5) Regulación al alza del nivel de proteína frataxina
    6) Escala de cambio de impresión global del clínico (CGI-C)
    7) Escala de cambio de impresión global del paciente (PGI-C)
    8) Seguridad
    9) Progresión de la 'Evaluación Cognitiva de Montreal' (MoCA)
    10) Modificación activa del locus FXN, medido por inmunoprecipitación de cromatina y secuenciación de captura de confirmación de cromosomas
    11) Cambio porcentual en el índice de masa ventricular izquierda medido por ecocardiograma
    12) Cambios estructurales y funcionales del cerebro y la médula espinal, medidos por resonancia magnética (MRI)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1), 2), 3), 4), 6), 7), 9) at baseline, +4 month, +8 month, +12 month, +18 month and +24 month
    5) at baseline, +12 month and +24 month
    8) at baseline, +1 month, +4 month, +8 month, +12 month, +18 month and +24 month
    10) at baseline, +12 month and +24 month
    11) at baseline, +12 month and +24 month
    12) at baseline and +24 month
    1), 2), 3), 4), 6), 7), 9) al inicio del estudio, +4 meses, +8 meses, +12 meses, +18 meses y +24 meses
    5) al inicio del estudio, +12 meses y +24 meses
    8) al inicio del estudio, +1 mes, +4 mes, +8 mes, +12 mes, +18 mes y +24 mes
    10) al inicio del estudio, +12 meses y +24 meses
    11) al inicio del estudio, +12 meses y +24 meses
    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 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 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 EEA9
    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 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
    Ultima visita del último sujeto
    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: 225
    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 state65
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 225
    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)
    None
    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 Decision2020-04-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-01
    P. End of Trial
    P.End of Trial StatusOngoing
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