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    Summary
    EudraCT Number:2012-002968-27
    Sponsor's Protocol Code Number:CFTY720D2402
    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:2012-11-29
    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 number2012-002968-27
    A.3Full title of the trial
    A 48-week, double-blind, randomized, multi-center, parallelgroup study comparing structural changes in the retina and evolution of visual function after immediate versus delayed treatment with fingolimod in patients with acute demyelinating optic neuritis
    Estudio doble ciego, aleatorizado, multicéntrico, de grupos paralelos, de 48 semanas de seguimiento para comparar los cambios estructurales en la retina y la evolución de la función visual tras el tratamiento inmediato frente al retardado con fingolimod en pacientes con neuritis óptica desmielinizante aguda
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the effects of fingolimod teatment in patients with acute demyelinating optic neuritis
    Estudio para evaluar los efectos del tratamiento con fingolimod en pacientes con neuritis optica desmielinizante aguda
    A.3.2Name or abbreviated title of the trial where available
    Study of efficacy and safety of fingolimod in acute demyelinating optic neuritis
    Estudio de eficacia y seguridad de fingolimod en neuritis optica desmielinizante aguda
    A.4.1Sponsor's protocol code numberCFTY720D2402
    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 SponsorNovartis Farmaceutica, S.A
    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 supportNovartis Pharma Services AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farmaceutica, S.A.
    B.5.2Functional name of contact pointDepartamento Médico (ICRO)
    B.5.3 Address:
    B.5.3.1Street AddressGran Via de les Corts Catalanes, 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number+34900353036
    B.5.5Fax number+34932479903
    B.5.6E-maileecc.novartis@novartis.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 Yes
    D.2.1.1.1Trade name GILENYA 0,5 mg capsulas duras
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    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 nameFingolimod
    D.3.2Product code FTY720D
    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 INNFingolimod
    D.3.9.1CAS number 162359- 56-0
    D.3.9.2Current sponsor codeFTY720D
    D.3.9.3Other descriptive nameFTY720
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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.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
    acute demyelinating optic neuritis
    neuritis optica desmielinizante aguda
    E.1.1.1Medical condition in easily understood language
    Acute demeylinating optic neuritis (ADON), is an inflammation of the optic nerve causing blurring, graying, or loss of vision, often with accompanying pain.
    acute demyelinating optic neuritis, es una inflamacion del nervio optico que causa visión borrosa, reducción de la visión en color, o pérdida de visión, con frecuencia acompañado de dolor.
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10030942
    E.1.2Term Optic neuritis
    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
    To assess if fingolimod will reduce the mean retinal nerve fiber layer (RNFL) thinning (measured as the OCT-determined difference between the RNFLT of the affected eye after 18 weeks of treatment and the baseline RNFLT of the fellow eye) relative to placebo in patients with suspected ADON, all of whom will receive standard steroid treatment.
    Evaluar si fingolimod 0,5 mg/día reducirá el adelgazamiento medio de la CFNR (medido como la diferencia determinada mediante OCT entre el ACFNR del ojo afectado después de 18 semanas de tratamiento y el ACFNR basal del ojo contralateral) respecto al placebo en pacientes con sospecha de NODA, todos ellos recibirán tratamiento estándar con corticoides
    E.2.2Secondary objectives of the trial
    ? To compare the impact of immediate treatment with fingolimod 0.5 mg/daily (48 weeks of continuous treatment) versus delayed treatment with fingolimod 0.5 mg/daily (18 weeks of placebo then 30 weeks of fingolimod) in patients with suspected ADON who are receiving standard treatment with steroids on the following outcomes:
    ? Low-contrast visual acuity of the affected eye assessed by low-contrast Sloan letter charts at 1.25 and 2.5% contrast levels at 48 weeks.
    ? Vision-based quality of life (QoL) as assessed by the QoL
    questionnaire NEI-VFQ-25 at weeks 18 and 48.
    ? The proportion of patients converting to 2010 McDonald MS (Polman et al. 2011) between the assessment at the screening visit and weeks 18 and 48.
    ? To evaluate the tolerability and safety of fingolimod in patients with ADON
    Comparar el impacto del tratamiento inmediato con fingolimod 0,5 mg/al día (48 semanas de tratamiento continuo) frente al tratamiento retardado con fingolimod 0,5 mg/al día (18 semanas de placebo, seguido de 30 semanas de fingolimod) en pacientes con sospecha de NODA que estén recibiendo tratamiento estándar con corticoides en los siguientes resultados:
    ? Agudeza visual en condiciones de bajo contraste del ojo afectado determinada mediante optotipos de letras Sloan con bajo contraste a niveles de contraste de 1,25 y 2,5% a las 48 semanas.
    ? Calidad de vida (QoL) basada en la visión evaluada mediante la puntuación compuesta del cuestionario de QoL NEI-VFQ-25 en las semanas 18 y 48.
    ? La proporción de pacientes con transformación a EM según los criterios de McDonald 2010 (Polman et al. 2011) entre la evaluación en la visita de selección y las semanas 18 y 48.
    ? Evaluar la tolerabilidad y seguridad de fingolimod en pacientes con NODA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ? Written informed consent must be obtained before any assessment is performed.
    ? Male and female patients aged between 18 and 50 years, inclusive.
    ? Clinical signs and symptoms of unilateral ADON (loss of vision, pain on movement, impairment of color vision) starting within the 14 days prior to intended randomization.
    ? The qualifying ADON must be the first clinical episode of a probable demyelinating disease.
    ? Able to undergo treatment with intravenous methylprednisolone (IVMP).
    ? Received first IVMP dose prior to Visit 2.
    1. Deberá obtenerse el consentimiento informado por escrito antes de que se realice ninguna evaluación.
    2. Pacientes hombres y mujeres de 18 a 50 años de edad, ambas edades inclusive.
    3. Signos y síntomas clínicos de NODA unilateral (pérdida de visión, dolor al moverse, alteración de la visión en color) comenzando dentro de los 14 días previos a la aleatorización prevista.
    4. La NODA para determinar la elegibilidad deberá ser el primer episodio clínico de una probable enfermedad desmielinizante.
    5. Capaz de recibir tratamiento con MPIV.
    6. Que hayan recibido la primera dosis de MPIV antes de la Visita 2.
    E.4Principal exclusion criteria
    ? History of any unexplained eye or neurological symptomatology lasting longer than 48 hours and indicative of a demyelinating disorder.
    ? Bilateral optic neuritis.
    ? Functionally or clinically relevant comorbidity of either eye such as glaucoma, optic nerve hypoplasia, macular full or partial thickness macular hole, macular edema, vitreomacular traction, epiretinal membrane, uveitis, or other diseases of the optic nerve or a history thereof.
    ? High clinical likelihood of a form of optic neuritis other than ADON (e.g., severe optic disk edema, atrophic optic disk, retinal exudates, or hemorrhages).
    ? Total average RNFL thickness of less than or equal to 80 ?m in the fellow eye (unaffected eye)
    ? Patients meeting any of the following cardiovascular conditions at Screening:
    a. history of cardiac arrest;
    b. severe untreated sleep apnea;
    c. history of myocardial infarction; congestive heart failure;
    d. ischemic heart disease;
    e. cerebrovascular disease;
    f. patients receiving current treatment with Class Ia or III
    antiarrhythmic drugs (e.g., quinidine, disopyramide, amiodarone, bretylium, sotalol, ibulitide, azimilide, dofelitide, ajmaline, procainamide).
    g. patients with relevant risk factors for QT prolongation, for
    example, hypokalaemia, hypomagnesemia or congenital QT prolongation;
    h. history or presence of a second-degree AV block Type II or
    third-degree AV block or corrected QTc inverval >450 msec in males and >470 msec in females corrected using Fridericia?s formula (based on screening ECG report from central reader);
    i. history of sick sinus syndrome or sino-atrial heart block;
    j. uncontrolled hypertension despite prescribed medications;
    k. resting heart rate <45 bpm;
    ? Patients receiving current treatment (at randomization) beta blockers, heart-rate slowing calcium channel blockers (e.g. ivadrabine, verapamil, or diltiazem), or other substances which may decrease heart rate such as digoxin, anticholinesteratic agents or pilocarpine.
    Advice from a cardiologist should be sought regarding the switch to non-heart-rate lowering medicinal products (for more details, please refer to Appendix 3)
    ? Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
    ? Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective contraception during the study and for 2 months after stopping treatment. ? Highly effective contraception ? is defined as contraception that results in less than 1% unwanted pregnancies when used properly according to the label.
    1. Antecedentes de cualquier sintomatología ocular o neurológica que se prolongue más de 48 horas y sea indicativa de un trastorno desmielinizante.
    2. Neuritis óptica bilateral.
    3. Alteraciones concurrentes funcionalmente o clínicamente relevantes del ojo no afectado por la NODA.
    4. Comorbilidad funcionalmente o clínicamente relevante de cualquier ojo.
    5. Alta probabilidad clínica de una forma de neuritis óptica distinta a NODA.
    6. OCT no evaluable en la selección.
    7. Grosor promedio total de la CFNR inferior o igual a 80 microm en el ojo contralateral (ojo no afectado)
    8. Error de refracción superior a ±8 dioptrías.
    9. Pacientes con una enfermedad crónica activa (o estable pero tratada con inmunoterapia) del sistema inmunitario distinta a NODA o con un síndrome de inmunodeficiencia conocido.
    10. Antecedentes de enfermedad maligna de cualquier sistema orgánico (distinta a carcinoma de células basales localizado de la piel), tratado o no tratado, en los últimos 5 años.
    11. Pacientes con diabetes mellitus no controlada (HbA1c >7%)
    12. Pacientes con infecciones activas severas o infecciones bacterianas, víricas, o fúngicas activas crónicas
    13. Haber recibido alguna vacuna viva o viva atenuada en el mes 1 previo a la aleatorización
    14. Pacientes que cumplan cualquiera de las siguientes condiciones cardiovasculares en la Selección:
    a. antecedentes de paro cardíaco;
    b. apnea del sueño grave no tratada;
    c. antecedentes de infarto de miocardio; insuficiencia cardíaca congestiva;
    d. cardiopatía isquémica;
    e. enfermedad cerebrovascular;
    f. pacientes que reciban tratamiento actual con antiarrítmicos de Clase Ia o III.
    g. pacientes con factores de riesgo relevantes de prolongación QT, por ejemplo, hipopotasemia, hipomagnesemia o prolongación QT congénita;
    h. antecedentes o presencia de bloqueo AV de segundo grado Tipo II o bloqueo AV de tercer grado o intervalo QTc corregido >450 mseg en hombres y >470 mseg en mujeres corregido utilizando la fórmula de Fridericia (en base al informe ECG de la selección que haga el lector central);
    i. antecedentes de síndrome del seno enfermo o bloqueo cardíaco sinoauricular;
    j. hipertensión no controlada a pesar de las medicaciones prescritas;
    k. frecuencia cardíaca en reposo menor a 45 lpm;
    15. Pacientes que reciban tratamiento actual (en la aleatorización) con betabloqueantes, bloqueadores de los canales del calcio que reduzcan la frecuencia cardíaca (p.ej., ivadrabina, verapamil o diltiazem), u otras sustancias que pueden reducir la frecuencia cardíaca.
    16. Pacientes con enfermedad respiratoria grave, fibrosis pulmonar, o enfermedad pulmonar obstructiva crónica de Clase III o IV
    17. Pacientes con alguna de las siguientes enfermedades hepáticas:
    ? antecedentes de alcoholismo, enfermedad hepática o biliar crónica, excepto síndrome de Gilbert;
    ? bilirrubina total o conjugada más de 1,5 veces el intervalo del límite superior de normalidad, salvo en el contexto del síndrome de Gilbert;
    ? fosfatasa alcalina (FA) más de 1,5 veces el intervalo del límite superior de normalidad
    ? AST (SGOT), ALT (SGPT) o gamma-glutamil-transferasa (GGT) más de 3 veces el intervalo del límite superior de normalidad
    18. Recuento de leucocitos <3.500/mm3 o recuento de linfocitos <800/mm3
    19. Pacientes con cualquiera de los siguientes trastornos neurológicos/psiquiátricos:
    ? antecedentes de abuso de sustancias (drogas) o cualquier otro factor (es decir, enfermedad psiquiátrica grave) que pueda interferir en la capacidad del paciente para cooperar y cumplir con los procedimientos del estudio;
    ? trastorno neurológico progresivo, distinto a NODA, que pueda afectar la participación en el estudio
    ? Puntuación 4 ó 5 en el ítem de Idea de Suicidio o algún ?sí? en el ítem de Conducta Suicida de la C-SSRS que esté relacionado con la conducta suicida que tenga lugar durante los últimos 2 años
    20. Pacientes que han sido tratados con :
    ? Cualquier medicación con un posible riesgo directo de toxicidad en retina o nervio óptico (p. ej., hidroxicloroquina, vigabatrina) que se haya tomado en la selección.
    ? corticoesteroides u hormonas adrenocorticotrópicas (ACTH) en los 30 días previos al inicio de la NODA.
    ? un fármaco o terapia en investigación en los 180 días o 5 semividas de la visita 2 (basal), lo que sea más largo.
    21. Alergia o hipersensibilidad a gadolinio.
    22. Antecedentes de hipersensibilidad a cualquiera de las medicaciones del estudio o a fármacos de clases químicas similares
    23. Incapacidad para someterse a exploraciones con RM.
    24. Mujeres embarazadas o en período de lactancia.
    25. Mujeres en edad fértil, salvo que estén utilizando anticoncepción altamente eficaz durante el estudio y durante los 2 meses siguientes a la interrupción del tratamiento. La ?anticoncepción altamente eficaz? se define como la anticoncepción que causa menos del 1% de embarazos no deseados cuando se utiliza de acuerdo con la ficha técnica.
    E.5 End points
    E.5.1Primary end point(s)
    RNFL thinning, to evaluate whether immediate treatment with fingolimod can reduce the axonal loss of retinal neurons following an episode of ADON
    La variable principal es la diferencia entre el GCFNR determinado mediante OCT del ojo afectado en la visita postbasal de la semana 18 y el GCFNR del ojo contralateral en la visita basal. En el resto del documento, a la variable principal se le referirá como ?cambio controlado con el ojo contralateral en el GCFNR?.
    E.5.1.1Timepoint(s) of evaluation of this end point
    after 18 weeks of treatment
    tras 18 semanas de tratamiento
    E.5.2Secondary end point(s)
    assessment of whether immediate treatment with fingolimod can reduce the loss of visual acuity following an episode of ADON
    evaluacion de si el tratamiento inmediato con fingolimod puede reducir la perdida de agudeza visual que sigue a un episodio de NODA
    E.5.2.1Timepoint(s) of evaluation of this end point
    when full stabilization of the visual function
    cuando se estabilice totalmnete la funcion visual
    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 No
    E.6.10Pharmacogenetic Yes
    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 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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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
    Canada
    Germany
    Italy
    Portugal
    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
    LVLS
    ultima visita del ultimo paciente
    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 months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days0
    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: 126
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 68
    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)
    none
    ninguno
    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 Decision2013-01-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-08
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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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
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