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    Summary
    EudraCT Number:2011-004867-65
    Sponsor's Protocol Code Number:CAFQ056B2154
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-03-29
    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 number2011-004867-65
    A.3Full title of the trial
    Sequential, two-period study to assess the pharmacokinetics, safety & tolerability of single and multiple oral doses of AFQ056 in patients with FXS (Fragile X syndrome) aged 5-11 years (Cohort 1) and 3-4 years (Cohort 2)
    Estudio secuencial de dos periodos para evaluar la farmacocinética, seguridad y tolerabilidad de una dosis única oral y de dosis múltiples orales de AFQ056 en pacientes con SXF (síndrome X frágil) entre 5 y 11 años de edad (cohorte 1) y entre 3 y 4 años de edad (cohorte 2)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study to assess the pharmacokinetics, safety & tolerability of single and multiple oral doses of AFQ056 in children with Fragile X Syndrome
    Estudio clínico para valorar la farmacocinética, seguridad y tolerabilidad de dosis orales únicas y múltiples de AFQ056 en niños con Síndrome de Cromosoma X Frágil
    A.4.1Sponsor's protocol code numberCAFQ056B2154
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01482143
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/152/2011
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovartis Farmacéutica, 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 Farmacéutica, S.A.
    B.5.2Functional name of contact pointJordi Guillén
    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+34933064953
    B.5.5Fax number+34933064274
    B.5.6E-mailjordi.guillen@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 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 nameAFQ056
    D.3.2Product code AFQ056
    D.3.4Pharmaceutical form Powder for oral suspension
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 543906-09-8
    D.3.9.2Current sponsor codeAFQ056
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    Fragile X Syndrome
    Sindrome X Frágil
    E.1.1.1Medical condition in easily understood language
    Fragile X Syndrome
    Sindrome X Frágil
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10017324
    E.1.2Term Fragile X syndrome
    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 pharmacokinetics of single and multiple oral AFQ056 doses in patients with FXS aged 5-11 years (cohort 1) and 3-4 years if included in the study (cohort 2)
    Evaluar la farmacocinética de una dosis única oral y de dosis múltiples orales de AFQ056 en pacientes con SXF entre 5 y 11 años de edad (cohorte 1) y entre 3 y 4 años de edad, si se incluyen en el estudio (cohorte 2).
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of single and multiple oral AFQ056 in patients with FXS aged 5 11 years (cohort 1) and 3-4 years if included in the study (cohort 2)
    Evaluar la seguridad y tolerabilidad de una dosis única oral y de dosis múltiples orales de AFQ056 en pacientes con SXF entre 5 y 11 años de edad (cohorte 1) y entre 3 y 4 años de edad, si se incluyen en el estudio (cohorte 2).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The Study includes an optional pharmacogenetic component which requires a separate signature to participate. It is required as part of this protocol for the Investigator to present this option to the patient?s parent/legal guardian.
    Exploratory pharmacogenetics research studies may be carried out as a part of this study with the objectives of identifying inherited genetic factors which may influence AFQ056
    pharmacokinetics and pharmacodynamics.
    El estudio incluye una parte farmacogenética opcional que requiere otra firma para participar. Como parte de este protocolo es necesario que el investigador presente esta opción al padre/madre/tutor legal del paciente

    Se pueden realizar estudios de investigación farmacogenética como parte de este estudio con el objetivo de identificar los factores genéticos hereditarios que pueden influir en la farmacocinética y farmacodinámica de AFQ056.
    E.3Principal inclusion criteria
    Genetically confirmed diagnosis of FXS

    At Screening and first baseline, vital signs, body weight and BMI must be age-specific within normal ranges
    Criterios de inclusión de la cohorte 1

    1. Pacientes niños y niñas con SXF entre 5 y 11 años de edad, ambos inclusive.

    2. Diagnóstico de SXF genéticamente confirmado (>200 repeticiones CGG en el gen fmr1 (si se dispone de datos históricos se pueden aceptar).

    3. En la visita de selección y en la primera visita basal, la temperatura corporal deberá ser entre 35,5-38,0 °C. Se deberán medir las constantes vitales (la presión arterial sistólica y diastólica y la frecuencia de pulso) y en caso de cambios clínicamente significativos según los investigadores, puede que el sujeto del estudio no sea incluido.

    En caso de cambio clínicamente significativo en las contantes vitales, el investigador puede obtener dos lecturas adicionales, de forma que se realice un total de tres (3) evaluaciones consecutivas. Para que el sujeto sea apto al menos la última lectura debe ser aceptable.

    4. El peso corporal debe ser ? percentil 10 específico de la edad y el sexo (véase Anexo 3)

    5. El IMC debe ser ? percentil 10 específico de la edad y el sexo (véase Anexo 4)

    6. El padre/madre/tutor legal debe ser capaz de comunicarse bien con el investigador, y debe entender y cumplir con los requisitos del estudio presentando el consentimiento informado por escrito.

    Criterios de inclusión de la cohorte 2

    1. Pacientes niños y niñas con SXF entre 3 y 4 años de edad, ambos inclusive.

    2. Diagnóstico de SXF genéticamente confirmado (>200 repeticiones CGG en el gen fmr1 (si se dispone de datos históricos se pueden aceptar).

    3. En la selección y en la primera basal la temperatura corporal deberá ser entre 35,5-38,0 °C. Se deberán medir las constantes vitales (la presión arterial sistólica y diastólica y la frecuencia de pulso) y en caso de cambios clínicamente significativos según los investigadores, puede que el sujeto del estudio no sea incluido.
    En caso de cambio clínicamente significativo en las contantes vitales, el investigador puede obtener dos lecturas adicionales, de forma que se realice un total de tres (3) evaluaciones consecutivas. Para que el sujeto sea apto al menos la última lectura debe ser aceptable.

    4. El peso corporal debe ser ? percentil 10 específico de la edad y el sexo (véase Anexo 3).

    5. El IMC debe ser ? percentil 10 específico de la edad y el sexo (véase Anexo 4).

    6. El padre/madre/tutor legal debe ser capaz de comunicarse bien con el investigador, y debe entender y cumplir con los requisitos del estudio presentando el consentimiento informado por escrito.
    E.4Principal exclusion criteria
    Use of any other investigational drug within 30 days or 5 half-lives (whichever is longer) of the investigational drug prior to screening until end of study visit.

    History of hypersensitivity to AFQ056 or any mGluR antagonist.

    Female patients who are confirmed or suspected to be sexually active.

    History or presence of any clinically significant disease of any major system organ class, within the past 2 years prior to screening including but not limited to psychiatric, neurological, cardiovascular, endocrine, metabolic, renal, or gastrointestinal disorders (except for typical features of FXS).

    Smokers.

    Loss of ?10% of total blood volume within 8 weeks (or less if required for this age group and/or by local regulation) prior to dosing or longer if required for this age group and/or by local regulation.


    Significant illness that did not completely resolve at least four weeks prior to the first baseline visit.

    Any abnormal laboratory values at screening or first baseline that are in the opinion of the investigator clinically significant and may jeopardize the safety of the study subject.

    Use of (or use within at least 5 half lives before dosing) concomitant medications that are strong/moderate inhibitors or inducers of CYP1A1/2, CYP2C9/19 or CYP3A4

    History or presence of Hepatitis B/C or HIV at screening.
    1. Uso de cualquier fármaco en investigación en el momento de inclusión o uso durante 30 días o 5 semividas (aquel periodo que sea más largo) de fármaco en investigación antes de la selección y hasta la visita de fin de estudio (o durante más tiempo si así lo exigen las normativas locales).

    2. Antecedentes de hipersensibilidad a AFQ056 o a cualquier antagonista de mGluR.

    3. Pacientes mujeres que se haya confirmado o se sospeche que son sexualmente activas.
    La actividad sexual debe ser evaluada de forma exhaustiva por el investigador a lo largo de una entrevista con el padre/madre/tutor legal en la selección. Asimismo, el investigador debe continuar evaluando la posibilidad de actividad sexual a lo largo del estudio y se le debe indicar al padre/madre/tutor legal que informe inmediatamente al investigador si la participante es sexualmente activa o se sospecha que es sexualmente activa durante el estudio. En estos casos, el investigador tomará las medidas adecuadas y la paciente deberá ser retirada del estudio.

    4. Antecedentes o presencia de enfermedad clínicamente significativa de cualquier sistema orgánico principal, durante los 2 últimos años antes de la selección, incluyendo entre otros trastornos psiquiátricos, neurológicos, cardiovasculares, endocrinos, metabólicos, renales o gastrointestinales. Esto no incluye las características típicas del SXF, como síntomas psicológicos, dismorfia o antecedentes de crisis epilépticas.

    5. Fumadores (consumo de tabaco durante los 3 meses anteriores).

    6. Pérdida de ?10% del volumen sanguíneo total durante las 8 semanas (o menos si así se exige en ese grupo de edad y/o según la normativa local) anteriores a la administración de la dosis o durante más tiempo si así se exige en ese grupo de edad y/o según la normativa local. El volumen sanguíneo total de un niño se deberá calcular basándose en las recomendaciones de la OMS (Boletín de WHO 2011).

    7. Enfermedad significativa que no se haya resuelto totalmente al menos cuatro semanas antes de la primera visita basal.

    8. Cualquier valor de laboratorio anómalo en la selección o en la primera visita basal que según el criterio del investigador sea clínicamente significativo y pueda poner en peligro la seguridad del sujeto del estudio.

    9. Uso de (o uso durante al menos 5 semividas antes de la administración de la dosis) medicación concomitante que sean inhibidores o inductores potentes/moderados de CYP1A1/2, CYP2C9/19 o CYP3A4 (véase Anexo 5).

    10. Pacientes que según la opinión del investigador no sean aptos para participar en este estudio (p. ej., debido a un cumplimiento limitado de los requisitos del estudio).

    11. Antecedentes de presencia de enfermedades de inmunodeficiencia, incluido un resultado positivo en la prueba de VIH (ELISA y Western blot).

    12. Un resultado positivo en la prueba de antígeno de superficie de la Hepatitis B (HBsAg) o Hepatitis C en la selección.
    E.5 End points
    E.5.1Primary end point(s)
    The area under the plasma (or serum or blood) concentration-time curve from time zero to infinity [mass x time / volume] (AUCinf)

    The area under the plasma (or serum or blood) concentration-time curve from time zero to the time of the last quantifiable concentration [mass x time
    / volume] (AUClast)

    Maximum observed plasma concentration (Cmax)
    Se analizarán las variables PK principales Cmax, AUCult y AUC? de AFQ056. Todos los sujetos con datos de al menos una de las variables de PK principales y sin ninguna desviación principal del protocolo serán incluidos en el análisis de datos PK.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The area under the plasma (or serum or blood) concentration-time curve from time zero to infinity [mass x time / volume] (AUCinf) :Time Frame: Day 1 (period 1): 0.5, 2, 4, 8, 12, 24 hours post-dose; Day 7 (period 2): pre-dose; 0.5, 2, 4, 8 hours post dose

    The area under the plasma (or serum or blood) concentration-time curve from time zero to the time of the last quantifiable concentration [mass x time
    / volume] (AUClast):Time Frame: Day 1 (period 1): 0.5, 2, 4, 8, 12, 24 hours post-dose; Day 7 (period 2): pre-dose; 0.5, 2, 4, 8 hours post dose

    Maximum observed plasma concentration (Cmax): Day 1 (period 1): 0.5, 2, 4, 8, 12, 24 hours post-dose; Day 7 (period 2): pre-dose; 0.5, 2, 4, 8 hours post dose
    AUC?:Dia 1 (periodo 1): 0.5, 2, 4, 8, 12, 24 horas post-dosis; Dia 7 (periodo 2): pre-dosis y 0.5, 2, 4, 8 horas post dosis

    AUCult:Dia 1 (periodo 1): 0.5, 2, 4, 8, 12, 24 horas post-dosis; Dia 7 (periodo 2): pre-dosis y 0.5, 2, 4, 8 horas post dosis

    Cmax:Dia 1 (periodo 1): 0.5, 2, 4, 8, 12, 24 horas post-dosis; Dia 7 (periodo 2): pre-dosis y 0.5, 2, 4, 8 horas post dosis
    E.5.2Secondary end point(s)
    Physical examination
    Vital signs and body measurements
    ECG
    hematology
    blood chemistry
    neurological examination
    Adverse events (AE) and Serious adverse events (SAE) monitoring
    Examen Físisco (1)
    Signos vitales y medidas corporales (2)
    ECG (3)
    Hematologia (4)
    Bioquimica (5)
    Examen neurologico (6)
    Monitorización de Eventos Adversos (7) y Eventos Adversos Graves (SAEs) (8)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Measure #1, 2, 3:Time Frame: Screening: once anytime between Day -30 and Day -1, Day -1 (period 1), once anytime between 24-72 hours after Day 7 (period 2)

    Measure #4, 5: Time Frame: Screening: once anytime between Day -30 and Day -1, Day -1 (period 1), Day -1 (period 2); once anytime between 24-72 hours after Day 7 (period 2)

    Measure #6:Time Frame: Screening: once anytime between Day -30 and Day -1, Day -1 (period 1), Day 7 (period 2)

    Measure #7:Time Frame: During the study (total of approximately 32 days) and 3 days after study completion

    Measure #8:Time Frame: During the study (total of approximately 32 days) and 30 days after study completion
    Medidas 1, 2 y 3: Screening: Periodo 1: Una sola vez entre el día -30 y el -1, Dia -1. Periodo 2: una sola vez entre 24-72 h tras el día 7.

    Medidas 4 y 5: Screening: Periodo 1: Una sola vez entre el día -30 y el -1, Dia -1. Periodo 2: Dia -1, una sola vez entre 24-72 h tras el día 7.

    Medida 6: Screening: Periodo 1: Una sola vez entre el día -30 y el -1, Dia -1. Periodo 2: Dia 7.

    Medida 7: Durante el estudio (aproximadamente 32 dias) y 3 dias tras completar el estudio.

    Medida 8: Durante el estudio (aproximadamente 32 dias) y 30 dias tras completar 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 No
    E.6.4Safety Yes
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tolerabilidad
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    PK, safety, tolerability
    Farmacocinética, seguridad y tolerabilidad
    E.7.2Therapeutic exploratory (Phase II) No
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 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
    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
    LPLV
    Ultima visita del ultimo paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months12
    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 Yes
    F.1.1Number of subjects for this age range: 24
    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: 24
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children from age 5 - 11 years (cohort 1) and age 3 - 4 years (cohort 2) with Fragile X syndrom. Fragile X syndrome is a form of mental retardation. The legal guardian or legally acceptable representative must sign Informed Consent.
    En la cohorte 1 se incluirán niños de entre 5 y 11 años de edad. En la cohorte 2 se incluirán niños de entre 3 y 4 años de edad. El SXF es una forma de retraso mental. El tutor o rpresentante legal aceptable deberá firmar el consentimiento informado.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2
    F.4.2.2In the whole clinical trial 24
    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 will be offered the opportunity to enroll into an open-label long-term extension study with AFQ056.
    A los pacientes se les ofrecerá la oportunidad de entrar en un estudio de extensión abierto de larga duación con AFQ056.
    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 Decision2012-05-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-10-16
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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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