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    Summary
    EudraCT Number:2011-003313-42
    Sponsor's Protocol Code Number:AGO-TEA
    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:2011-11-30
    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 number2011-003313-42
    A.3Full title of the trial
    Efficacy of agomelatine on sleep disturbance in Autism Spectrum Disorder (ASD)
    Eficacia de agomelatina en la alteración del sueño en el Trastorno del Espectro Autista (TEA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Agomelatine efficacy of the drug to improve sleep problems in autistic people
    Eficacia del fármaco agomelatina para mejorar los problemas del sueño en personas autistas
    A.4.1Sponsor's protocol code numberAGO-TEA
    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 SponsorHospital General Universitario de Alicante
    B.1.3.4CountrySpain
    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 supportHospital General Universitario de Alicante
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital General Universitario de Alicante
    B.5.2Functional name of contact pointFundación Investigación HGUA
    B.5.3 Address:
    B.5.3.1Street AddressPintor Baeza
    B.5.3.2Town/ cityAlicante
    B.5.3.3Post code03010
    B.5.3.4CountrySpain
    B.5.4Telephone number+34965913868
    B.5.5Fax number+34965913896
    B.5.6E-mailpeiro.anamaria@gmail.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 Valdoxan 25mg
    D.2.1.1.2Name of the Marketing Authorisation holderLes Laboratoires Servier Industrie
    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 nameAgomelatine
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPBuccal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAGOMELATINE
    D.3.9.1CAS number 138112-76-2
    D.3.9.4EV Substance CodeSUB05286MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25 to mg
    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 placeboTablet
    D.8.4Route of administration of the placeboBuccal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The treatment of sleep disorders in patients with autism spectrum disorders (ASD)
    El tratamiento de los trastornos del sueño en los pacientes con trastornos del espectro autista (TEA)
    E.1.1.1Medical condition in easily understood language
    The treatment of sleep problems in autistic patients
    El tratamiento de los problemas del sueño en los pacientes autistas
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To study the efficacy of agomelatine in improving the quantity and quality of sleep in patients with ASD as recorded by an integrated variable TAP.
    Estudiar la eficacia de agomelatina en la mejora de la cantidad y calidad de sueño en pacientes con TEA según el registro de una variable integrada TAP.
    E.2.2Secondary objectives of the trial
    Analysis of (1) safety and tolerability of agomelatine in ASD, (2) Expression of clock genes and the presence of genetic variants in the way melatonergic, (3) Correlation of clinical variables (sleep logs and questionnaires), hormonal (cortisol and melatonin) and genetic (4) Analysis of a combination of variables that may predispose to associate better pharmacological response to agomelatine.
    Análisis de (1) Tolerabilidad y seguridad de agomelatina en TEA, (2) Expresión de los genes reloj y de la presencia de variantes genéticas en la vía melatoninérgica, (3) Correlación de variables clínicas (registros de sueño y cuestionarios), hormonales (cortisol y melatonina) y genéticas, (4) Análisis de una combinación de variables que pudiesen predisponer a asociar una mejor respuesta farmacológica a agomelatina.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet all the following criteria:

    1.Adults patients between 18 and 65 years old, of both sexes.
    2.Patients diagnosed according ICD-10 criteria for ASD.
    3.Patients with sleep handicaps (diagnosed according to ICSD-2), after a month to implement sleep hygiene measures.
    From the Center
    4.Infanta Leonor of Alicante Patients(outpatient and internal).
    os pacientes deberán cumplir todos los criterios siguientes:

    1.Pacientes adultos entre 18 y 65 años de edad, de ambos sexos.
    2.Pacientes diagnosticados según criterios ICD-10 de TEA.
    3.Pacientes que presenten dificultades del sueño (diagnosticados segun ICSD-2), tras un mes de implementar medidas de higiene del sueño.
    4.Pacientes provenientes del Centro Infanta Leonor de Alicante (ambulatorios e internos).
    E.4Principal exclusion criteria
    Patients with one or more of the following criteria are NOT eligible to participate in the study:
    1.Patients who suffer from: epilepsy, physical disability,
    2.Patients treated with psychotropic drugs, treatment with inhibitors of CYP1A2
    3.Patients with adverse liver function: transaminases ≥ 1.5 times the normal value.
    4.Patients with lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome or inability to take oral medication.
    5.Patients suffering intercurrent infections or uncontrolled or severe.
    6.Patients undergoing major surgical procedures, biopsies, or those who have had significant traumatic injury 1 month before the study, or scheduled for major surgery.
    Los pacientes que presenten uno o más de los siguientes criterios NO son seleccionables para participar en el estudio:
    1.Pacientes que padezcan: Epilepsia, discapacidad física,
    2.Pacientes en tratamiento con psicotrópicos, tratamiento con inhibidores del CYP1A2
    3.Pacientes que presenten alteraciones de la función hepática: transaminasas ≥1.5 veces el valor normal.
    4.Pacientes con falta de integridad física del tracto gastrointestinal superior, síndrome de mala absorción o incapacidad para tomar medicación oral.
    5.Pacientes que sufran infecciones o enfermedades intercurrentes no controladas o severas.
    6.Pacientes sometidos a procedimientos de cirugía mayor, biopsias o aquellos que hayan tenido lesiones traumáticas significativas 1 mes antes del estudio, o los programados para cirugía mayor.
    E.5 End points
    E.5.1Primary end point(s)
    Determination of the TAP variable [TAP = ((1-T) + A + P) / 3 where 0 corresponds to total relaxation and sleep, and 1 busy periods] *.

    * Calculated as described by Ortiz-Tudela et al. (2011): a) Record the temperature (T) by a sensor programmed to measure every 10 minutes on the wrist. Naturally, the temperature of the doll has the highest values ​​when the subject is asleep and the lowest for the day when awake, while the opposite is true in the case of motor activity and body position. Therefore, be invested temperature values ​​for the maximum values ​​of the 3 variables at the same time match of the day, b) actímetro (A) on the biceps of the subject, you can record the acceleration of the axes X, Y and Z readings static position. The sensor is programmed to record data every 30 seconds and define two variables: motor activity (A, expressed as degrees of change in position, being the sum of the first derivative of the angle between the normal position and the position sensor 30 s advance taking into account the X, Y and Z), c) body position (P, calculated as the angle between the axis X of A and a horizontal plane, ranging from 0 ° horizontal and 90 ° vertical high maximum). The information stored in the records are transferred to a computer and will be reviewed by the team of Dr. Madrid (see financial report).
    Determinación de la variable TAP [TAP=((1-T)+A+P)/3 donde 0 corresponderá a descanso total y dormido, y 1 a periodos de mucho movimiento]*.
    *Calculada según describe Ortiz-Tudela et al. (2011): a) Registro de la temperatura (T) mediante un sensor programado para medir cada 10 minutos en la muñeca. De forma natural, la temperatura de la muñeca tiene los valores más altos cuando el sujeto está dormido y los más bajos por el día cuando está despierto, mientras que ocurre lo contrario en el caso de actividad motora y posición corporal. Por ello, se invertirán los valores de temperatura para que los valores máximos de las 3 variables coincidan en el mismo momento del día, b) El actímetro (A) situado en el bíceps del sujeto, puede registrar la aceleración de los ejes X, Y y Z y lecturas de posición estática. El sensor se programará para registrar los datos cada 30 segundos y definiremos 2 variables: actividad motora (A, expresada como grados de cambio en la posición, siendo la suma de la primera derivativa del ángulo formado entre la posición sensor normal y su posición 30 s antes, teniendo en cuenta los ejes X, Y y Z), y c) Posición corporal (P, calculada como el ángulo entre el eje X del A y un plano horizontal, oscilando entre 0º horizontalidad máxima y 90º verticalidad máxima). La información almacenada en los registros se transferirá a un ordenador y será analizado por el equipo del Dr. Madrid (ver memoria económica).
    E.5.1.1Timepoint(s) of evaluation of this end point
    one week, one week and one week
    1 semana, 1 semana y 1 semana
    E.5.2Secondary end point(s)
    Analysis of the expression of clock genes (Per1, period 1, NPAS2, neuronal PAS domain protein 2) by qPCR and analysis of the presence of genetic variants by Rotor-Gene on the road melatonergic (ASMT receptors and melatonin receptors 1A and 1B (MTNR1A, B) [c.-376G> A, C-38C> T and IVS5 +2 T> C in ASMT, c.-158c> T and c.370G MTNR1A> A and c.-39 GC > MTNR1B AA] (Johsson et al., 2010).
    Determinations hormone melatonin (09:00 AM and 11 PM) and cortisol (9AM) before and after each period (Brzezinski, 1997) in saliva to be held in the Clinical Analysis Laboratory HGUA.
    Correlation of clinical variables (sleep diaries and questionnaires): Sleep Quality Index in Pittsburgh, Epworth Sleepiness Scale, Assessment-Questionnaire SMAG adherence to compliance, assessment, quality of life questionnaire SF-30 MOS-, Scale, Hospital Anxiety and Depression (HADS), hormonal (melatonin and cortisol) and genetics.
    Analysis of a combination of variables that may predispose to associate better pharmacological response to agomelatine.
    Análisis de la expresión de los genes reloj (Per1, period 1; NPAS2, neuronal PAS domain protein 2) por qPCR y análisis de la presencia de variantes genéticas por Rotor-Gene en la vía melatoninérgica (receptores ASMT y los receptores de la melatonina 1A y 1B (MTNR1A, B) [c.-376G>A, C.-38C>T y IVS5+2T>C en ASMT; c.-158C>T en MTNR1A y c.370G>A y c.-39 GC>AA en MTNR1B] (Johsson et al., 2010).
    Determinaciones hormonales de melatonina (09:00 AM y a 11PM) y cortisol (9AM) antes y después de cada período (Brzezinski, 1997) en saliva que se realizarán en el laboratorio de Análisis Clínicos del HGUA.
    Correlación de variables clínicas (diarios de sueño y cuestionario): Índice de calidad de sueño de Pittsburgh, Escala de somnolencia de Epworth, Evaluación de la adherencia-Cuestionario SMAG de cumplimiento terapéutico, Evaluación de la calidad de vida-Cuestionario MOS-SF-30, Escala Hospitalaria de Ansiedad y Depresión (HADS), hormonales (melatonina y cortisol) y genéticas.
    Análisis de una combinación de variables que pudiesen predisponer a asociar una mejor respuesta farmacológica a agomelatina.
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 times
    3 veces
    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 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 Yes
    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 No
    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
    The treatment of sleep disorders in patients with ASD continues to be inadequate appearing between 40-80% of cases. This study assessed the efficacy of agomelatine administration in improving the quality and quantity of sleep for people with ASD, trying to correlate its improvement with clinical, hormonal and genetic, that might involve a better drug response.
    El tratamiento de los trastornos del sueño en los pacientes con TEA continua siendo inadecuado presentándose entre el 40-80% de los casos. En este estudio se valorará la eficacia de la administración de agomelatina en la mejora de la calidad y cantidad de sueño de las personas con TEA, intentando correlacionar su mejoría con variables clínicas, hormonales y genéticas, que pudiesen asociar una mejor respuesta farmacológica.
    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 months11
    E.8.9.1In the Member State concerned 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: 40
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    People with autism spectrum disorders (ASD)
    Personas con trastornos del espectro autista (TEA)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    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)
    no
    no
    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 Decision2012-03-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-29
    P. End of Trial
    P.End of Trial StatusOngoing
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