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    Summary
    EudraCT Number:2012-005435-87
    Sponsor's Protocol Code Number:FIBHGM-ECNC002-2012
    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:2012-12-20
    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 number2012-005435-87
    A.3Full title of the trial
    EFFECT OF ADJUVANT TREATMENT WITH N - ACETYLCYSTEINE DURING 48 WEEKS ON THE LOSS OF GREY SUBSTANCE AND OXIDATIVE METABOLISM IN PATIENTS WITH EARLY ONSET PSYCHOTIC EPISODES: BLIND, PLACEBO-CONTROLLED, RANDOMIZED CLINICAL TRIAL
    EFECTO DEL TRATAMIENTO ADYUVANTE CON N - ACETILCISTEÍNA DURANTE 48 SEMANAS SOBRE LA PÉRDIDA DE SUSTANCIA GRIS Y EL METABOLISMO OXIDATIVO EN PACIENTES CON PRIMEROS EPISODIOS PSICÓTICOS DE INICIO TEMPRANO: ENSAYO CLÍNICO ALEATORIZADO, DOBLE-CIEGO, CONTROLADO CON PLACEBO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EFFECT OF ADJUVANT TREATMENT WITH N - ACETYLCYSTEINE DURING 48 WEEKS ON THE LOSS OF GREY SUBSTANCE AND OXIDATIVE METABOLISM IN PATIENTS WITH EARLY ONSET PSYCHOTIC EPISODES: BLIND, PLACEBO-CONTROLLED, RANDOMIZED CLINICAL TRIAL
    EFECTO DEL TRATAMIENTO ADYUVANTE CON N - ACETILCISTEÍNA DURANTE 48 SEMANAS SOBRE LA PÉRDIDA DE SUSTANCIA GRIS Y EL METABOLISMO OXIDATIVO EN PACIENTES CON PRIMEROS EPISODIOS PSICÓTICOS DE INICIO TEMPRANO: ENSAYO CLÍNICO ALEATORIZADO, DOBLE-CIEGO, CONTROLADO CON PLACEBO
    A.4.1Sponsor's protocol code numberFIBHGM-ECNC002-2012
    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 SponsorFundación para la Investigación Biomédica Hospital Gregorio Marañón
    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 supportFundación para la Investigación Biomédica Hospital Gregorio Marañón
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundación para la Investigación Biomédica Hospital Gregorio Marañón
    B.5.2Functional name of contact pointGoretti Moron
    B.5.3 Address:
    B.5.3.1Street AddressDr. Esquerdo 46
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28007
    B.5.3.4CountrySpain
    B.5.4Telephone number0034914265005
    B.5.5Fax number0034914265005
    B.5.6E-mailgoretti.moron@iisgm.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 ACETILCISTEINA FARMASIERRA 600 mg
    D.2.1.1.2Name of the Marketing Authorisation holderFarmasierra Laboratorios S. L.
    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 nameN-acetylcysteine
    D.3.4Pharmaceutical form Powder and solvent for oral solution
    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 INNACETYLCYSTEINE
    D.3.9.1CAS number 616-91-1
    D.3.9.4EV Substance CodeSUB05229MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1200 to 3000
    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 placeboPowder and solvent for oral solution
    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
    PATIENTS WITH EARLY ONSET PSYCHOTIC EPISODES
    PACIENTES CON PRIMEROS EPISODIOS PSICÓTICOS DE INICIO TEMPRANO
    E.1.1.1Medical condition in easily understood language
    PATIENTS WITH EARLY ONSET PSYCHOTIC EPISODES
    PACIENTES CON PRIMEROS EPISODIOS PSICÓTICOS DE INICIO TEMPRANO
    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 10061920
    E.1.2Term Psychotic disorder
    E.1.2System Organ Class 10037175 - Psychiatric 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 evaluate the variations in volume of gray matter in patients with early onset psychotic episodes after 48 weeks of treatment with NAC or placebo
    Evaluar las variaciones en volumen de sustancia gris en pacientes con primeros episodios de psicosis de inicio temprano tras 48 semanas de tratamiento con NAC o placebo
    E.2.2Secondary objectives of the trial
    -To assess the changes in the concentrations of brain GSH in patients with early onset psychotic episodes before and after treatment
    -To assess the changes in oxidative metabolic status of patients in patients with early onset psychotic episodes before and after treatment
    - To Assess variations in volume of white matter in patients in patients with early onset psychotic episodes after treatment
    - To relate the loss of volume of gray matter in patients with early onset psychotic episodes with markers of oxidative stress.
    - To study markers of central and peripheral oxidative stress as possible biomarkers that can predict response to NAC.
    - To compare the changes in clinical and psychopathology scales (CGI, PANSS, YMRS, HAM-D)
    - To compare the changes in the psychosocial functioning (C-GAS, WHO-DAS) after treatment
    - To compare the required antipsychotic doses
    - To compare the frequency and intensity of adverse effects associated with neuroleptic treatment (AIMS, BARS)
    - Evaluar cambios en concentraciones de GSH cerebral en pacientes con primeros episodios de psicosis de inicio temprano antes y después
    - Evaluar cambios en estatus metabólico oxidativo de pacientes con primeros episodios de psicosis de inicio temprano antes y después
    - Evaluar variaciones en volumen de sustancia blanca en pacientes con primeros episodios de psicosis de inicio temprano
    - Relacionar pérdida de volumen de sustancia gris en pacientes con primeros episodios de psicosis de inicio temprano con marcadores de estrés oxidativo.
    - Estudiar marcadores estrés oxidativo central y periférico como posibles biomarcadores que puedan predecir la respuesta a tratamiento con NAC.
    - Comparar cambios en escalas clínicas y psicopatológicas (CGI, PANSS, YMRS, HAM-D)
    - Comparar cambios en el funcionamiento psicosocial (C-GAS, WHO-DAS)
    - Comparar dosis de antipsicótico requeridas
    - Comparar frecuencia e intensidad de efectos adversos asociada a tratamiento neuroléptico (AIMS, BARS)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1 Age between 12 and 18 years;
    2 Presence of at least one psychotic symptom of onset before 18 years of age, with a diagnosis of psychotic disorder criteria DSM-IV (F20 or F30), evaluated through the K-SADS (Kiddie Schedule for Affective Disorders and Schizophrenia);
    3 Previous exposure to antipsychotics ? 30 days;
    4 Informed consent of the patient and of the guardian or legal representative.
    1.Edad entre 12 y 18 años;
    2.Presencia de al menos un síntoma psicótico de inicio antes de los 18 años de edad, con diagnóstico de un trastorno psicótico según criterios DSM-IV (F20 o F30), evaluado por medio de la K-SADS (Kiddie Schedule for Affective Disorders and Schizophrenia);
    3.Exposición previa a antipsicóticos ? 30 días;
    4.Consentimiento informado para el estudio del paciente y del tutor o representante legal.
    E.4Principal exclusion criteria
    1 Co-morbidity with other disorders of axis I, included abuse or dependence on toxic (use is accepted);
    2. Presence of organic diseases of the central nervous system (CNS) or a history of head trauma with loss of consciousness;
    3. Mental retardation;
    4. Pervasive development disorders;
    5. Clinically relevant renal, hepatic or haematological findings in the analysis of screening;
    6. Active medical conditions (e.g. seizures not controlled);
    7 Patients with ulcus gastroduodenal, asthmatic or with severe respiratory failure;
    8 Persons who have previously submitted adverse effects to the NAC or any of the components of the preparation;
    9 Pregnancy, breastfeeding or risk of pregnancy (contraceptive measures an intrauterine device, oral contraceptives and barrier methods are considered);
    10 People who are in treatment with other agents antioxidants or precursors of GSH, except if treatment has been abandoned at least 3 weeks;
    11 Patients who are participating or have participated in another clinical trial during the previous 30 days;
    12 Patients unable to meet the requirements of the study.
    1. Comorbilidad con otros trastornos del Eje I, incluido el abuso o dependencia de tóxicos (se acepta el uso);
    2. Presencia de enfermedades orgánicas del sistema nervioso central (SNC) o antecedentes de traumatismos craneoencefálicos con pérdida de conciencia;
    3. Retraso mental;
    4. Trastornos generalizados del desarrollo;
    5. Hallazgos renales, hepáticos o hematológicos clínicamente relevantes en la analítica de screening;
    6. Enfermedades médicas activas (p.ej. convulsiones no controladas);
    7. Pacientes con ulcus gastroduodenal, asmáticos o con insuficiencia respiratoria grave;
    8. Personas que hayan presentado efectos adversos previamente a la NAC o a cualquiera de los componentes de la preparación;
    9. Embarazo, lactancia o riesgo de embarazo (se consideran medidas anticonceptivas adecuadas un dispositivo intrauterino, los anticonceptivos orales y los métodos de barrera);
    10. Personas que estén en tratamiento con otros agentes antioxidantes o precursores del GSH, salvo si se ha abandonado el tratamiento hace al menos 4 semanas;
    11. Pacientes que estén participando o hayan participado en otro ensayo clínico durante los 30 días previos;
    12. Pacientes incapaces para cumplir los requisitos del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Volumetric changes in frontal gray matter (right over left) measured by nuclear magnetic resonance (NMR) after 48 weeks of adjuvant treatment with NAC or placebo.
    Cambios volumétricos en sustancia gris frontal (derecha más izquierda) medidos mediante resonancia magnética nuclear (RMN) tras 48 semanas de tratamiento adyuvante con NAC o placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    48 weeks
    48 semanas
    E.5.2Secondary end point(s)
    1. Changes in cerebral GSH concentrations measured by spectroscopy (MRS) after 48 weeks of treatment with NAC or placebo.
    2 Volumetric changes in brain white matter measured by diffusion (DTI) after 48 weeks of treatment with NAC or placebo.
    3. Changes in the values of markers of oxidative metabolism after 48 weeks of adjuvant treatment with NAC and placebo in a year.
    4. Changes in the score in clinical and psychopathology scales (CGI, PANSS, YMRS, HAM-D) and psychosocial functioning (C-GAS, WHO-DAS) after 48 weeks of adjuvant treatment with NAC or placebo.
    5 Doses of antipsychotic and extrapyramidal side effects of antipsychotic treatment (AIMS, BARS) after 48 weeks of treatment with NAC or placebo
    1.Cambios en las concentraciones de GSH cerebral medidos por espectroscopía (MRS) tras 48 semanas de tratamiento con NAC o placebo.
    2.Cambios volumétricos en sustancia blanca cerebral medidos por difusión (DTI) tras 48 semanas de tratamiento con NAC o placebo.
    3.Cambios en los valores de marcadores del metabolismo oxidativo tras 48 semanas de tratamiento adyuvante con NAC y placebo al año.
    4.Cambios en la puntuación en las escalas clínicas y psicopatológicas (CGI, PANSS, YMRS, HAM-D) y de funcionamiento psicosocial (C-GAS, WHO-DAS) tras 48 semanas de tratamiento adyuvante con NAC o placebo.
    5.Dosis de antipsicótico y efectos extrapiramidales secundarios de tratamiento antipsicótico (AIMS, BARS) tras 48 semanas de tratamiento con NAC o placebo.
    E.5.2.1Timepoint(s) of evaluation of this end point
    48 weeks
    48 semanas
    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) No
    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 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 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 concerned2
    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 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
    LVLS
    Ultima visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    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 Yes
    F.1.1Number of subjects for this age range: 70
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 70
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 30
    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
    Patients with at least at least one early psychotic symptoms
    Paientes con de al menos un síntoma psicótico de inicio
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state90
    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)
    Expected normal treatment of the disease
    Tratamiento normal esperado de esta enfermedad
    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 Decision2013-02-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-11
    P. End of Trial
    P.End of Trial StatusOngoing
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