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    Summary
    EudraCT Number:2021-001278-44
    Sponsor's Protocol Code Number:CLZ_TRS_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:2021-09-01
    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 number2021-001278-44
    A.3Full title of the trial
    Comparative analysis of the effectiveness of clozapine in resistant schizophrenia and schizoafective disorder.
    Análisis comparativo de la efectividad de la clozapina en esquizofrenia
    resistente y trastorno esquizoafectivo.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparative analysis of the effectiveness of clozapine in resistant schizophrenia and schizoafective disorder.
    Análisis comparativo de la efectividad de la clozapina en esquizofrenia
    resistente y trastorno esquizoafectivo.
    A.4.1Sponsor's protocol code numberCLZ_TRS_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 SponsorFundación Hospital Provincial de Castellón
    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 Hospital Provincial de Castellón
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundación Hospital Provincial de Castellón
    B.5.2Functional name of contact pointFundación Hospital Provincial de Ca
    B.5.3 Address:
    B.5.3.1Street AddressAvenida del Doctor Clará, 19
    B.5.3.2Town/ cityCastellon
    B.5.3.3Post code12002
    B.5.3.4CountrySpain
    B.5.6E-mailclaperam@gmail.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Clozapine
    D.2.1.1.2Name of the Marketing Authorisation holderAUROVITAS SPAIN, S.A.U.
    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 nameClozapine
    D.3.4Pharmaceutical form 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 INNCLOZAPINE
    D.3.9.1CAS number 0005786-21-0
    D.3.9.3Other descriptive nameCLOZAPINE
    D.3.9.4EV Substance CodeSUB06787MIG
    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.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
    Treatment-resistant schizophrenia and schizoafective disorder
    Esquizofrenia resistente al tratamiento y en trastorno esquizoafectivo
    E.1.1.1Medical condition in easily understood language
    Treatment-resistant schizophrenia and schizoafective disorder, both are mental disorder.
    Esquizofrenia resistente al tratamiento y en trastorno esquizoafectivo, ambos enfermedades de salid mental.
    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
    Evaluate the effectiveness of clozapine, in association with other antipsychotics, in reducing psychotic symptomatology in treatment-resistant schizophrenia and schizoafective disorder.
    Evaluar la eficacia de la clozapina, en asociación con otros antipsicóticos, a la hora de reducir sintomatología psicótica y afectiva en esquizofrenia resistente al tratamiento y en el trastorno esquizoafectivo.
    E.2.2Secondary objectives of the trial
    1-Study the tolerability of clozapine in treatment-resistant schizophrenia and schizoafective disorder., identifying differences and similarities.
    2-Determine the existence of clinical and/or sociodemographic characteristics that help predict the response to clozapine
    1-Estudiar la tolerabilidad de Clozapina en esquizofrenia resistente al tratamiento y en el trastorno esquizoafectivo, identificando diferencias y similitudes.
    2.Determinar la existencia de características clínicas y/o sociodemográficas que ayuden a predecir la respuesta a clozapina.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Patients diagnosed with treatment-resistant schizophrenia or schizoafective disorder, regardless of consumption (or not) psychoactive substances.
    2.Patients who at the time of recruitment maintain values in the PANSS equal to or greater than 80, despite the prescribed pharmacological regimen.
    3.Patients who accept, by signing informed consent, voluntarily participate in the study. In patients with capacity modification, the consent of the guardian will be required.
    4.Patients who have clozapine prescribed below the minimum therapeutic dose prescribed for the trial (150 mg daily)
    1. Pacientes con diagnóstico de esquizofrenia resistente al tratamiento o
    trastorno esquizoafectivo, independientemente de la presencia o no de
    consumo de sustancias psicoactivas.
    2. Pacientes que en el momento del reclutamiento mantengan valores en
    la PANSS iguales o superiores a 80, a pesar de la pauta farmacológica prescrita.
    3. Pacientes que acepten, mediante la firma del consentimiento informado, participar voluntariamente en el estudio. En aquellos pacientes
    con modificación de la capacidad, se requerirá el consentimiento del
    tutor.
    4. Pacientes que tengan prescrita la clozapina por debajo de la dosis mínima terapéutica preestablecida para el ensayo (150 mg diarios)
    E.4Principal exclusion criteria
    1.Patients with other psychiatric diagnoses, different from those reflected in the inclusion criteria.
    2. Patients with treatment-resistant schizophrenia or schizoaffective disorder who score below 80 in PANSS at the time of recruitment or have more than 150 mg of clozapine prescribed daily.
    3. Pacientes que presenten contraindicaciones absolutas para la prescripción de clozapina: prescripción de tratamiento mielosupresor, antecedentes de agranulocitosis, enfermedades mieloproliferativas, epilepsia no controlada, depresión del SNC o íleo paralítico.
    1. Pacientes con otros diagnósticos psiquiátricos diferentes a los reflejados en los criterios de inclusión.
    2. Pacientes con esquizofrenia resistente al tratamiento o trastorno esquizoafectivo que, en el momento del reclutamiento puntúen por debajo de 80 en la PANSS o tengan prescrito más de 150 mg diarios de clozapina.
    3. Pacientes que presenten contraindicaciones absolutas para la prescripción de clozapina: prescripción de tratamiento mielosupresor, antecedentes de
    granulocitosis, enfermedades mieloproliferativas, epilepsia no controlada, depresión del SNC o íleo paralítico.
    E.5 End points
    E.5.1Primary end point(s)
    Assess changes (relationship to reducing psychotic symptomatology), and magnitude, in the PANSS scale score in patients with Treatment-resistant schizophrenia and schizoafective disorder. A 25% reduction in the PANSS will be considered to be significant improvement.
    Valorar los cambios, y la magnitud de éstos, en la puntuación de la escala PANSS en pacientes con esquizofrenia resistente al tratamiento y en el trastorno esquizoafectivo. Se considera como mejoría significativa una reducción del 25% en la puntuación de dicha escala.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The follow-up time to evaluate the changes will be 3 months.
    El tiempo de seguimiento para evaluar los cambios esta estimado en 3 meses.
    E.5.2Secondary end point(s)
    1-To assess tolerability, the UKU scale score will be assessed.
    2-Compare the response to Clozapine in the different groups and study correlations of it with the variables included in the sociodemographic, clinical and therapeutic profile.
    1-Valorar la puntuación de la escala UKU.
    2-Comparar la respuesta a CLZ en los diferentes grupos y estudiar correlaciones de ésta con las variables incluidas en el perfil sociodemográfico, clínico y terapéutico.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The follow-up time to evaluate the changes will be 3 months.
    El tiempo de seguimiento para evaluar los cambios esta estimado en 3 meses.
    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 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 Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    other antipsychotic (clinical practice)
    E.8.2.4Number of treatment arms in the trial3
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months36
    E.8.9.1In the Member State concerned days
    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: 108
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 No
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state120
    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)
    When the subject has ended the participation, the subject will have a follow-up by the usual clinical practice.
    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 Decision2021-05-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-20
    P. End of Trial
    P.End of Trial StatusOngoing
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