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    Summary
    EudraCT Number:2014-000456-29
    Sponsor's Protocol Code Number:FCD-ADA-1401
    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:2014-07-22
    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 number2014-000456-29
    A.3Full title of the trial
    EFFICACY AND SAFETY OF INHALED LOXAPINE COMPARED WITH IM ANTIPSYCHOTIC IN ACUTELY AGITATED PATIENTS WITH SCHIZOPHRENIA OR BIPOLAR DISORDER
    EFICACIA Y SEGURIDAD DE LA LOXAPINA INHALADA EN COMPARACIÓN CON UN ANTIPSICÓTICO INTRAMUSCULAR EN PACIENTES CON AGITACIÓN AGUDA ASOCIADA A ESQUIZOFRENIA O SÍNDROME BIPOLAR
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of treatment with inhaled loxapine and an injected drug to treat patients with schizophrenia or bipolar disorder and who are seriously agitated
    Comparación del tratamiento con loxapina inhalada y un medicamento inyectado para tratar a pacientes con esquizofrenia o trastorno bipolar y que se agitan gravemente
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code numberFCD-ADA-1401
    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 SponsorFerrer Internacional, 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 supportFerrer Internacional, S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFerrer Internacional, S.A.
    B.5.2Functional name of contact pointClinical Development
    B.5.3 Address:
    B.5.3.1Street AddressAvda. Diagonal, 549
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08029
    B.5.3.4CountrySpain
    B.5.4Telephone number+3493 600 37 00
    B.5.5Fax number+3493 600 38 74
    B.5.6E-maildesarrollo.clinico@ferrer.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 ADASUVE
    D.2.1.1.2Name of the Marketing Authorisation holderAlexza UK, 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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAdasuve
    D.3.4Pharmaceutical form Inhalation powder, pre-dispensed
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNloxapine
    D.3.9.1CAS number 1977-10-2
    D.3.9.3Other descriptive nameLOXAPINE
    D.3.9.4EV Substance CodeSUB08607MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number9.1
    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.IMP: 2
    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 ABILIFY
    D.2.1.1.2Name of the Marketing Authorisation holderOtsuka Pharmaceutical Europe Ltd.
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameABILIFY
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNARIPIPRAZOLE
    D.3.9.1CAS number 129722-12-9
    D.3.9.4EV Substance CodeSUB05564MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.5
    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
    SCHIZOPHRENIA AND BIPOLAR DISORDER
    Esquizofrenia y síndrome bipolar
    E.1.1.1Medical condition in easily understood language
    psychotic disorder and mood disorder
    trastorno del estado de ánimo y trastorno psicótico
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10039626
    E.1.2Term Schizophrenia
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10057667
    E.1.2Term Bipolar 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 efficacy, defined as time to response (where response is defined as a Clinical Global Impression of Improvement [CGI I] score of 1 ["Very much improved"] or 2 ["Much improved"]), of inhaled loxapine 9.1 mg as compared with aripiprazole 9.75 mg administered as an intramuscular (IM) injection in acutely agitated patients with schizophrenia or bipolar disorder.
    Evaluar la eficacia, definida como el tiempo hasta la respuesta (donde la respuesta se define como una puntuación de Impresión clínica global de mejoría [CGI-I] de 1 [?Enorme mejoría?] o 2 [?Gran mejoría?]) a la loxapina inhalada 9,1 mg en comparación con aripiprazol 9,75 mg, administrado mediante inyección intramuscular (IM), en pacientes con agitación aguda asociada a esquizofrenia o síndrome bipolar.
    E.2.2Secondary objectives of the trial
    - To evaluate efficacy, defined as percentage of responders at 10, 20, 30, 50, 60, 90 and 120 minutes of inhaled loxapine 9.1 mg as compared with aripiprazole 9.75 mg IM.
    - To assess the proportion of patients who needed an additional dose of study medication.
    - To assess the proportion of patients who needed rescue medication.
    - To assess patient satisfaction with inhaled loxapine compared with aripiprazole.
    - To evaluate and compare the safety and tolerability of study medication.
    - Evaluar la eficacia, definida como el porcentaje de pacientes que responde al tratamiento 10, 20, 30, 50, 60, 90 y 120 minutos después de la loxapina inhalada 9,1 mg en comparación con el aripiprazol 9,75 mg IM.
    - Evaluar la proporción de pacientes que necesita una dosis adicional del medicamento del ensayo.
    - Evaluar la proporción de pacientes que necesita medicación de rescate.
    - Evaluar la satisfacción de los pacientes con la loxapina inhalada en comparación con el aripiprazol.
    - Evaluar y comparar la seguridad y la tolerabilidad de los medicamentos del ensayo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female patients between the ages of 18 to 65 years, inclusive.
    2. Patients who met Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for schizophrenia or bipolar disorder I.
    3. Patients judged to be clinically agitated at baseline with a value of >/= 4 and < 6 (moderately, markedly agitated) out of the 7 items on the CGI-S scale.
    4. Written informed consent from patients with documented adequate consent capacity per the Investigator's judgement.
    5. Patients in good general health prior to study participation as judged by the Investigator and stated in the patient's record.
    1. Pacientes de ambos sexos de 18 a 68 años, inclusive.
    2. Pacientes que cumplan los criterios del Manual diagnóstico y estadístico de los trastornos mentales (DSM)-5 para esquizofrenia o síndrome bipolar I.
    3. Pacientes que se considere que están clínicamente agitados en la visita basal, con un valor >/= 4 y < 6 (moderada o notablemente agitados) de los 7 elementos de la escala CGI-S.
    4. Consentimiento informado por escrito de los pacientes con una capacidad de consentimiento adecuada, a criterio del investigador, documentada.
    5. Pacientes con un buen estado de salud general antes de su participación en el ensayo, a criterio del investigador, documentado en la historia clínica del paciente.
    E.4Principal exclusion criteria
    1. Patients with agitation caused primarily by acute intoxication (as per Investigator's judgment).
    2. Patients with acute alcohol or psychoactive drugs intoxication/withdrawal symptoms incompatible with their participation in the study as judged by the Investigator.
    3. Patients judged to be at serious risk for suicide as per the Investigator's judgement.
    4. Patients treated with benzodiazepines or other hypnotics or oral or short-acting IM antipsychotics within 4 hours prior to study drug administration (however, those patients may be subsequently reassessed for inclusion).
    5. Patients treated with injectable depot neuroleptics or long-acting second generation antipsychotics within 1 dose interval prior to study drug administration (however, those patients may be subsequently reassessed for inclusion).
    6. Patients with a history of allergy or intolerance to loxapine or amoxapine and/or aripiprazole.
    7. Female patients of childbearing potential who have a positive urine pregnancy test at screening or breastfeeding or inpatients who previously had a positive serum pregnancy test upon admission.
    8. Patients with previous laboratory or electrocardiogram abnormalities considered relevant by the Investigator that may have clinical implications for the patient's participation in the study.
    9. Patients with significant hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease and congestive heart failure), endocrinologic, neurologic or hematologic disease.
    10. Patients with acute respiratory signs/symptoms (e.g., wheezing) or with active airways disease (such as patients with asthma or chronic obstructive pulmonary disease).
    11. Patients who received an investigational drug within 30 days prior to screening.
    12. Patients who are considered by the Investigator, for any reason, to be unsuitable candidates for receiving inhaled loxapine, or are likely to be unable to use the inhalation device.
    1. Pacientes con agitación causada principalmente por una intoxicación aguda (a juicio del investigador).
    2. Pacientes con síntomas de abstinencia o intoxicación aguda por alcohol o fármacos psicoactivos, incompatibles con su participación en el ensayo a juicio del investigador.
    3. Pacientes que el investigador considere que tienen un riesgo importante de suicidio.
    4. Pacientes tratados con benzodiacepinas u otros somníferos, o con antipsicóticos IM de acción breve orales en las 4 horas anteriores a la administración del fármaco del ensayo (no obstante, se podrá volver a evaluar a estos pacientes más tarde para su inclusión).
    5. Pacientes tratados con neurolépticos inyectables de liberación lenta o antipsicóticos de acción prolongada de segunda generación en un intervalo de 1 dosis antes de la administración del fármaco del ensayo (no obstante, se podrá volver a evaluar a estos pacientes más tarde para su inclusión).
    6. Pacientes con antecedentes de alergia o intolerancia a la loxapina o la amoxapina, y/o al aripiprazol.
    7. Mujeres en edad fértil que tengan un resultado positivo en una prueba de embarazo en orina en la selección o que estén amamantando, o las pacientes ingresadas que hayan tenido anteriormente un resultado positivo en una prueba de embarazo en suero realizada en el momento del ingreso.
    8. Pacientes con anomalías de laboratorio o del electrocardiograma anteriores, que el investigador considere relevantes y puedan tener implicaciones clínicas para la participación del paciente en el ensayo.
    9. Pacientes con enfermedad hepática, renal, digestiva, respiratoria, cardiovascular (incluida la cardiopatía isquémica y la insuficiencia cardiaca congestiva), hormonal, neurológica o hematológica importante.
    10. Pacientes con signos o síntomas respiratorios agudos (como sibilancias), o enfermedad activa de las vías respiratorias (como los pacientes con asma o enfermedad pulmonar obstructiva crónica).
    11. Pacientes que hayan recibido un producto en investigación en los 30 días anteriores a la selección.
    12. Pacientes que el investigador considere, por cualquier motivo, que no son candidatos aptos para recibir loxapina inhalada, o que sea probable que no puedan utilizar el dispositivo de inhalación.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy Endpoint:
    - Time to response, where response is defined as a CGI I score of 1 ("Very much improved") or 2 ("Much improved").
    Criterio de valoración de la eficacia:
    - Tiempo hasta la respuesta, donde la respuesta se define como una puntuación de CGI-I de 1 (?Enorme mejoría?) o 2 (?Gran mejoría?).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Post treatment Evaluation Period, which will start with the administration of Dose 1 of the study medication and will continue for at least 4 hours and for a maximum of 24 hours after Dose 1 or the end of the agitation episode as per the Investigator's judgement, whichever occurs first.
    Periodo de evaluación posterior al tratamiento, que comenzará con la administración de la dosis 1 del medicamento del ensayo y continuará durante al menos 4 horas y un máximo de 24 horas después de la dosis 1, o el final del episodio de agitación a criterio del investigador, lo que ocurra primero.
    E.5.2Secondary end point(s)
    Exploratory Endpoints:
    - The proportion of responders, as defined by a CGI-I score of 1 or 2 at 10, 20, 30, 50, 60, 90 and 120 minutes after the first dose of study drug administration.
    - The value of the CGI-I score at 10, 20, 30, 50, 60, 90 and 120 minutes following Dose 1 of inhaled loxapine compared with aripiprazole.
    - Total number of patients per group who received 1 or 2 doses of study medication with and without rescue medication by 4 hours and 24 hours after Dose 1 or the end of the agitation episode as per the Investigator's judgement, whichever occurs first.
    - Time to rescue medication during the entire Post-treatment Evaluation Period.
    - Time to Dose 2 (PRN) of study medication during the Post-treatment Evaluation Period as compared between groups.
    - Satisfaction with study treatment (based on Item 14 of the TSQM) as compared between groups.
    Criterios de valoración exploratorios:
    - La proporción de pacientes que responda al tratamiento, definida por una puntuación de CGI-I de 1 o 2, 10, 20, 30, 50, 60, 90 y 120 minutos después de la administración de la primera dosis del medicamento del ensayo.
    - El valor de la puntuación de CGI-I 10, 20, 30, 50, 60, 90 y 120 minutos después de la dosis 1 de loxapina inhalada, en comparación con el aripiprazol.
    - Número total de pacientes por grupo que hayan recibido 1 o 2 dosis del medicamento del ensayo, con o sin medicación de rescate, 4 horas y 24 horas después de la dosis 1 o del final del episodio de agitación, a juicio del investigador, lo que ocurra primero.
    - Tiempo hasta la medicación de rescate durante todo el periodo de evaluación posterior al tratamiento.
    - Tiempo hasta la dosis 2 (en caso necesario) del medicamento del ensayo durante el periodo de evaluación posterior al tratamiento, comparado entre los grupos.
    - Satisfacción con el tratamiento del ensayo (basada en el elemento 14 del TSQM), comparada entre los grupos.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Berween 10 minutes and 24 hours after the first dose of study drug administration.
    Entre 10 minutos y 24 horas después de la primera administración del medicamento del 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 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 Yes
    E.6.13.1Other scope of the trial description
    - Satisfaction with study treatment
    - Satisfacción con el tratamiento del ensayo
    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 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 Yes
    E.8.1.7.1Other trial design description
    evaluador ciego
    assessor-blind
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Czech Republic
    Germany
    Russian Federation
    Spain
    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
    LPLV
    Última visita del último 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 months11
    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 months11
    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 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: 468
    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 Yes
    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 state125
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 312
    F.4.2.2In the whole clinical trial 468
    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)
    None
    Ninguno
    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 Decision2014-11-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-10-31
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