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    EudraCT Number:2009-015844-41
    Sponsor's Protocol Code Number:EMR700773-002
    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:2014-01-16
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2009-015844-41
    A.3Full title of the trial
    A Phase IV Open-Label, Single-Cohort Study of the Long-Term Neurocognitive Outcomes in 4 to 5 Year-Old Children with Phenylketonuria Treated with Sapropterin Dihydrochloride (Kuvan®) for 7 Years.
    Estudio de fase IV, abierto y de una sola cohorte, de los resultados neurocognitivos (NC) a largo plazo en niños de 4 a 5 años con fenilcetonuria tratados con dihidrocloruro de sapropterina (Kuvan®) durante 7 años
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of the Long-term Effects on Mental Abilities of 4 to 5 Year-old Children with a Disease Caused by an Enzyme Defect (Phenylketonuria) that Have Been Treated with Kuvan® (a Medicinal Product aimed at Restoring the Defect) for 7 Years.
    Estudio sobre los efectos a largo plazo en las habilidades mentales en niños de 4 a 5 años con una enfermedad causada por el déficit en una enzima (fenilcetonuria) que hayan sido tratados con Kuvan® (un producto medicinal destinado a restaurar ese déficit) durante 7 años.
    A.3.2Name or abbreviated title of the trial where available
    KOGNITO (Kuvan®'s effect on the cOGNITion of children with phenylketOnuria)
    KOGNITO (Efecto de Kuvan® sobre la cognición de niños con fenilcetonuria)
    A.4.1Sponsor's protocol code numberEMR700773-002
    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 SponsorMerck KGaA
    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 supportMerck KGaA
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck KGaA
    B.5.2Functional name of contact pointCommunication Center Merck KGaA
    B.5.3 Address:
    B.5.3.1Street AddressFrankfurter Strasse 250
    B.5.3.2Town/ cityDarmstadt
    B.5.3.3Post code64293
    B.5.4Telephone number+496151725200
    B.5.5Fax number+496151722000
    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. name Kuvan
    D. of the Marketing Authorisation holderMerck Serono Europe Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/04/199
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Soluble tablet
    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 INNSAPROPTERIN
    D.3.9.1CAS number 62989-33-7
    D.3.9.3Other descriptive nametetrahydrobiopterin
    D.3.9.4EV Substance CodeSUB10445MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    E.1.1.1Medical condition in easily understood language
    Disease, where a genetic defect leads to non-functional enzyme, causing accumulation of an amino acid (phenylalanine) in the body and the presence of a related substance in urine (phenylketonuria)
    Enfermedad, en la que un defecto genético produce una enzima no funcional, que causa acúmulo en el cuerpo de un aminoácido (fenilalanina) y la presencia de un derivado en orina (fenilcetonuria)
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10034873
    E.1.2Term Phenylketonuria (PKU)
    E.1.2System Organ Class 100000004850
    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 this trial is to evaluate the long-term neurocognitive (NC) outcomes in children with hyperphenylalaninemia (HPA) due to phenylketonuria (PKU) treated with Kuvan® and a phenylalanine (Phe)-restricted diet for 7 years.
    El objetivo principal de este ensayo consiste en evaluar los resultados neurocognitivos (NC) a largo plazo en niños con hiperfenilalaninemia (HPA) debida a fenilcetonuria (PKU) tratados con Kuvan® y una dieta baja en fenilalanina durante 7 años.
    E.2.2Secondary objectives of the trial
    The main secondary objectives of this trial are to evaluate the growth and safety in children with HPA due to PKU treated with Kuvan® and a Phe-restricted diet and followed for a period of 7 years.
    Los objetivos secundarios fundamentales de este ensayo consisten en evaluar el crecimiento y la seguridad en niños con HPA debida a fenilcetonuria tratados con Kuvan® y una dieta baja en fenilalanina, y sometidos a seguimiento durante un periodo de 7 años.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The target population for this trial is children with confirmed diagnosis of PKU.

    Inclusion criteria:
    - Male or female outpatients, 4 to 5 years of age (>or=4 and <6) at the time of ICF signature by parent(s) or guardian(s).
    - Confirmed clinical and biochemical diagnosis of PKU, including at least two separate blood Phe levels >or=400 micromol/L.
    - Defined pre-Kuvan®/-tetrahydrobiopterin (BH4) dietary Phe tolerance consistent with the diagnosis of /PKU.
    - Responsive to Kuvan®/BH4:
    - For subjects currently treated with Kuvan®/BH4 at Screening: subject is a responder as per Investigator judgment based on documented effect of Kuvan®/BH4 on Phe levels and/or Phe tolerance.
    - For subjects not treated with Kuvan®/BH4 at Screening: a response test has been performed during Screening or is available from the patient's medical records and satisfies the 3 following criteria: a decrease in blood Phe levels of at least 30% was observed after at least 24 hours with a dose of at least 10 mg/kg/day.
    - IQ >or=70, as assessed with the WPPSITM-III 2nd part.
    Note: If a subject has undertaken the same test up to 3 months before Screening as part of his/her clinical follow-up, the score can be recorded and the test doesn't need to be repeated.
    - Good adherence with dietary treatment (including prescribed dietary Phe restriction and prescribed amounts of Phe-free protein supplements and low-Phe foods), as assessed by the Investigator.
    - Well-controlled Phe levels, as assessed by a minimum of 75% of Phe levels within the target recommended in each centre during the previous 3 months.
    - Low Phe diet started within the first 3 weeks of life.
    - Parent(s) or guardian(s) willing to comply with all study procedures, maintain strict adherence with the diet, and willing and able to provide written, signed informed consent before any trial-related activities are carried out, as well as ability of child to comply with trial procedures.
    La población destinataria de este ensayo consiste en niños con diagnóstico confirmado de fenilcetonuria.
    Criterios de inclusión
    - Pacientes ambulatorios de ambos sexos, de 4 a 5 años de edad (>o=4 y <6) en el momento de la firma del documento de consentimiento informado por el(los) progenitor(es) o tutor(es).
    - Diagnóstico de fenilcetonuria con confirmación clínica y bioquímica, incluido un mínimo de dos valores independientes de concentración sanguínea de fenilalanina >o=400 µmol/L.
    - Tolerancia definida a la fenilalanina alimentaria antes de la administración de Kuvan®/tetrahidrobiopterina (BH4) compatible con el diagnóstico de fenilcetonuria.
    - Con respuesta a Kuvan®/BH4:
    - En los sujetos tratados actualmente con Kuvan®/BH4 en la selección: el sujeto es un "respondedor" a juicio del investigador según el efecto documentado de Kuvan®/BH4 sobre la concentración de fenilalanina y/o la tolerancia a la fenilalanina.
    - En los sujetos no tratados con Kuvan®/BH4 en la selección: se ha realizado una prueba de respuesta durante la selección o se dispone de sus resultados en la historia clínica del paciente y cumple los tres criterios siguientes: se ha observado una disminución de la concentración sanguínea de fenilalanina de un mínimo del 30 % transcurrido un mínimo de 24 horas con una dosis de un mínimo de 10 mg/kg/día.
    - Coeficiente intelectual (IQ) >o=70, evaluado con la segunda parte de la escala WPPSITM-III.
    Nota: Si se ha realizado esta misma prueba a un sujeto hasta 3 meses antes de la selección como parte de su seguimiento clínico, podrá registrarse la puntuación, sin necesidad de repetir la prueba.
    - Buen cumplimiento del tratamiento dietético (incluida la dieta baja en fenilalanina prescrita y las cantidades prescritas de suplementos proteínicos sin fenilalanina y alimentos bajos en fenilalanina), a juicio del investigador.
    - Concentración de fenilalanina bien controlada, a juzgar por un mínimo del 75 % de la concentración de fenilalanina dentro del objetivo recomendado en cada centro durante los 3 meses anteriores.
    - Dieta baja en fenilalanina, comenzada en las 3 primeras semanas de vida.
    - Progenitor(es) o tutor(es) dispuestos a cumplir todos los procedimientos del estudio, mantener un cumplimiento estricto de la dieta, y con voluntad y capacidad de otorgar su consentimiento informado por escrito, firmado, antes de la práctica de cualquier actividad relacionada con el ensayo, así como capacidad del niño de cumplir los procedimientos del ensayo.
    E.4Principal exclusion criteria
    - Known hypersensitivity to Kuvan® or its excipients.
    - Known hypersensitivity to other approved or non-approved formulations of tetrahydrobiopterin.
    - Previous diagnosis of BH4 deficiency.
    - Current use of methotrexate, trimethoprim or other dihydrofolate reductase inhibitors.
    - Current use of medications that are known to affect nitric oxide synthesis, metabolism or action.
    - Current use of experimental or unregistered drugs (other than sapropterin/BH4) that may affect the study outcomes or use of such agents within 30 days prior to Screening.
    - Concurrent use of levodopa.
    - Concurrent disease or condition that would induce repeatedly catabolic situations, or interfere with the trial participation, diet, or NC development, as assessed by the Investigator.
    - Any condition that, in the view of the Investigator, renders the subject at high risk for failure to comply with treatment or to complete the trial.
    - Participation in a clinical trial investigating any other agent than Kuvan® within the past 30 days.
    - Hipersensibilidad conocida a Kuvan® o a sus excipientes.
    - Hipersensibilidad conocida a otras formulaciones aprobadas o no aprobadas de tetrahidrobiopterina.
    - Diagnóstico previo de deficiencia de BH4.
    - Uso actual de metotrexato, trimetoprim u otros inhibidores de la dihidrofolato-reductasa.
    - Uso actual de medicamentos con un efecto conocido sobre la síntesis, el metabolismo o la acción del óxido nítrico.
    - Uso actual de fármacos experimentales o no registrados (distintos de sapropterina/BH4) que pudieran influir en los resultados del estudio o uso de dichos agentes en el plazo de los 30 días anteriores a la selección.
    - Uso concomitante de levodopa.
    - Enfermedad o trastorno concomitante que pudiera inducir situaciones catabólicas repetidas, o influir en la participación en el ensayo, la dieta o el desarrollo NC, a juicio del investigador.
    - Cualquier trastorno que, en opinión del investigador, supusiera para el sujeto un gran riesgo de incumplir el tratamiento o de no completar el ensayo.
    - Participación en un ensayo clínico de investigación de cualquier otro agente distinto de Kuvan® en el plazo de los últimos 30 días.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the mean IQ score of PKU children on diet and treated with Kuvan® after 7 years of treatment in the study.
    El criterio principal de valoración será la puntuación media del coeficiente intelectual (IQ) de niños fenilcetonúricos a dieta y tratados con Kuvan® tras 7 años de tratamiento en el estudio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 7 years of treatment with Kuvan® in the study.
    A los 7 años de tratamiento con Kuvan® en el estudio.
    E.5.2Secondary end point(s)
    - Height and weight compared to the World Health Organization (WHO) Growth Standards at each time point.
    - Blood levels of tyrosine (Tyr), tryptophan, pre-albumin, and methylmalonic acid compared to age-related norms.
    - IQ score and subscores at each time-point:
    -the Verbal IQ, the Performance IQ and the Full Scale IQ (FSIQ) of the WPPSITM III at baseline;
    -the Verbal Comprehension, the Perceptual Reasoning, the Working Memory, the Processing Speed Indexes and the FSIQ of the WISC®-IV at post-baseline time-points.
    - Change from baseline in FSIQ score at 2, 4 and 7 years.
    - Dietary Phe tolerance over the 7 year period, as represented by mean Phe prescription (in mg/day and mg/kg/day) quarterly and mean Phe intake (in mg/day) bi-annually.
    - Monthly Phe levels and Phe levels on the day of the IQ test.
    - IDC (Index of Dietary Control = half-year Phe level medians averaged from baseline to 2, 4 and 7 years).
    - Adherence to treatment (diet+Kuvan®) as assessed by the percentage of monthly Phe levels within target blood Phe concentration during Study Period and adherence to Kuvan® treatment as assessed by percentage of tablets taken.
    - Frequencies and distributions of phenylalanine hydroxylase (PAH) genotype and relationships with response to Kuvan®/BH4.
    - Safety (extent of exposure to Kuvan®; nature, incidence, and severity of adverse events (AEs)/serious adverse events (SAEs), including relationship to trial treatment, AEs/SAEs leading to dose modification or discontinuation of trial treatment; changes and abnormalities in vital signs and safety laboratory parameters; physical examination; use of concomitant medications).
    - Altura y peso en comparación con los patrones de crecimiento de la Organización Mundial de la Salud (OMS).
    - Concentraciones sanguíneas de tirosina (Tyr), triptófano, prealbúmina y ácido metilmalónico en comparación con la normalidad según la edad.
    - Puntuación y subpuntuaciones del coeficiente intelectual (IQ) en cada punto de tiempo:
    - Valores en el momento basal del IQ verbal, el IQ de rendimiento y el IQ a escala completa (FSIQ) de la escala WPPSITM-III.
    - Valores en los puntos de tiempo posteriores al momento basal de los índices de comprensión verbal, razonamiento perceptual, memoria de trabajo y velocidad de procesamiento, y el FSIQ de la escala WISC®-IV.
    -Cambio respecto al momento basal de la puntuación del FSIQ a los 2, 4 y 7 años.
    - Tolerancia a la fenilalanina alimentaria durante el periodo de 7 años, a juzgar por la prescripción media trimestral de fenilalanina (en mg/día y en mg/kg/día) y el consumo medio semestral de fenilalanina (en mg/día).
    - Concentración mensual de fenilalanina y concentración de fenilalanina el día de la prueba de coeficiente intelectual (IQ).
    - Índice de control de la dieta (IDC; Index of Dietary Control = promedio de los valores semestrales de la mediana de concentración de fenilalanina entre el momento basal y los 2, 4 y 7 años).
    - Cumplimiento del tratamiento (dieta+Kuvan®) en su evaluación mediante el porcentaje de la concentración mensual de fenilalanina dentro de la concentración sanguínea objetivo de fenilalanina durante el periodo del estudio y cumplimiento del tratamiento con Kuvan® en su evaluación mediante el porcentaje de comprimidos tomados.
    - Frecuencia y distribución del genotipo de la fenilalanina-hidroxilasa (PAH) y las relaciones con la respuesta a Kuvan®/BH4.
    - Seguridad (magnitud de la exposición a Kuvan®; naturaleza, incidencia y severidad de los acontecimientos adversos (AE)/acontecimientos adversos graves (SAE), incluida la relación con el tratamiento del ensayo, AE/SAE que conduzcan a una modificación de la dosis o al abandono del tratamiento del ensayo; cambios y alteraciones de las constantes vitales y los parámetros de los análisis de laboratorio con fines de seguridad; exploración física; uso de medicamentos concomitantes).
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 7 years of treatment with Kuvan® in the study.
    A los 7 años de tratamiento con Kuvan® en 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 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 No
    E.6.11Pharmacogenomic Yes
    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. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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 No
    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
    This trial will be completed after:
    - All enrolled subjects who have received at least one dose of study drug have completed all scheduled visits or have prematurely discontinued
    - Follow-up of all subjects with ongoing AEs at the conclusion of treatment has been addressed
    - Site monitoring visits to resolve any outstanding data discrepancy issues have been completed
    - The database has been locked
    - All sites have undergone a final site closure termination visit.
    Este ensayo habrá finalizado después de que:
    - Todos los sujetos admitidos que hayan recibido por lo menos una dosis del fármaco del estudio hayan concluido todas las visitas programadas o hayan abandonado o sido retirados prematuramente; y
    - Se haya establecido el seguimiento de todos los sujetos con AE en curso a la conclusión del tratamiento; y
    - Se haya cerrado la base de datos; y
    - Todos los centros hayan pasado la visita final de cierre del centro/terminación del estudio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    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 years8
    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: 30
    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. of subjects for this age range: 30
    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 No
    F.3.3.7Others Yes
    F. of other specific vulnerable populations
    paediatric patients
    F.4 Planned number of subjects to be included
    F.4.1In the member state11
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 30
    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)
    After a subject has completed the trial or has withdrawn prematurely, standard treatment for PKU should be continued in accordance with the trial site's standard-of-care and generally-accepted medical practices and depending on the subject's individual medical needs. Subjects may continue to receive Kuvan® treatment post-study if prescribed by a physician in a country where the drug has marketing authorization and is commercially available.
    Después de que un sujeto haya finalizado el ensayo o se haya retirado prematuramente, continuará el tratamiento habitual de la fenilcetonuria de acuerdo con la práctica habitual del centro del ensayo y la práctica médica generalmente aceptada, y en función de sus necesidades médicas concretas. Podrán continuar recibiendo tratamiento con Kuvan® después del estudio si se lo receta un médico en un país donde el fármaco haya recibido la autorización de comercialización y esté comercializado.
    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 Decision2013-10-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-14
    P. End of Trial
    P.End of Trial StatusOngoing
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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