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    Summary
    EudraCT Number:2011-004109-25
    Sponsor's Protocol Code Number:P261-402
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-03-01
    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 number2011-004109-25
    A.3Full title of the trial
    An Open-Label Safety Study of USL261 in the Outpatient Treatment of Subjects with Seizure Clusters
    Un estudio de seguridad en abierto de USL261 en el tratamiento ambulatorio de sujetos con crisis en racimo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Open-Label Safety Study of USL261 in the Outpatient Treatment of Subjects with Seizure Clusters
    Un estudio de seguridad en abierto de USL261 en el tratamiento ambulatorio de sujetos con crisis en racimo
    A.4.1Sponsor's protocol code numberP261-402
    A.5.4Other Identifiers
    Name:US IND NumberNumber:77,421
    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 SponsorUpsher-Smith Laboratories, Inc.
    B.1.3.4CountryUnited States
    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 supportUpsher-Smith Laboratories, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPharmanet Ltd.
    B.5.2Functional name of contact pointRegulatory Operations
    B.5.3 Address:
    B.5.3.1Street AddressGlory Park Avenue, Building Two
    B.5.3.2Town/ cityWooburn Green, Bucks
    B.5.3.3Post codeHP10 0DF
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44870 242 0780
    B.5.5Fax number+44870 242 0781
    B.5.6E-mailRegOpsEurope@pharmanet.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 No
    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 nameIntranasal midazolam
    D.3.2Product code USL261
    D.3.4Pharmaceutical form Nasal spray, solution in single-dose container
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntranasal use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMIDAZOLAM
    D.3.9.1CAS number 59467-70-8
    D.3.9.2Current sponsor codeUSL261
    D.3.9.4EV Substance CodeSUB08950MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    Epilepsy
    Epilepsia
    E.1.1.1Medical condition in easily understood language
    Epilepsy
    Epilepsia
    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 LLT
    E.1.2Classification code 10015052
    E.1.2Term Epileptic seizure
    E.1.2System Organ Class 10029205 - Nervous system 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 long-term safety and tolerability of USL-261 in the treatment of seizure clusters using the following:
    ? Occurrence of respiratory depression after study drug administration (defined as < 8 breaths per minute and/or a sustained decrease in respiratory effort requiring emergency rescue treatment with assisted breathing or intubation).
    ? AEs
    ? Clinical laboratory measurements.
    ? OAA/S Sum Score and Composite Scores at the end of the seizure cluster (within 6 hours after study drug administration).
    ? Physical, nasal, and neurological examinations.
    ? Vital sign measurements.
    ? C-SSRS
    ? Requirement for ER or EMS visits.
    Evaluar la tolerabilidad y seguridad a largo plazo de USL261 en el tratamiento de crisis en racimo mediante la
    medición de lo siguiente:
    - Aparición de depresión respiratoria después de la administración del fármaco del estudio (definida como < 8 respiraciones por minuto y/o disminución sostenida en el esfuerzo respiratorio que requiere tratamiento de rescate de emergencia con respiración asistida o intubación).
    - AA.
    - Análisis clínicos de laboratorio.
    - Escala de evaluación del observador de alerta/sedación y puntuaciones compuestas al final de la crisis en racimo (en el plazo de 6 horas después de la administración del fármaco del estudio).
    - Exámenes neurológicos, nasales y físicos.
    - Medición de las constantes vitales.
    - Escala de clasificación de la severidad del suicidio de Columbia
    - Necesidad de acudir de manera imprevista a Urgencias o a los servicios médicos de urgencia
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject or subject?s legally acceptable representative (LAR) has provided written informed consent, and subject has provided written assent where required by local law or Institutional Review Board (IRB) / Independent Ethics Committee (IEC) policy.
    2. Subject has a competent, adult (age ?18 years) caregiver(s) who is able to recognize and observe the subject?s seizure cluster episodes, willing to be trained in the study procedures, and has provided written informed consent; the caregiver(s) must be a relative, partner, friend, or LAR who has a significant personal relationship with the subject.
    3. Subject is between 14 and 66 years of age, inclusive, at Visit 1.
    4. Subject has an established diagnosis of partial or generalized epilepsy.
    5. Subject has a documented history of seizure clusters, with a pattern that is observable, stereotyped, and recognizably different from the subject?s other non-cluster seizure activity; subject?s seizure clusters must:
    a. be of the same type that was approved by the central reviewer in study P261-401.
    b. last at least 10 minutes after being recognized as a seizure cluster.
    c. last no more than 6 hours.
    d. be composed of multiple (?2) partial or generalized seizures.
    e. be established > 3 months before Visit 1 of study P261-401.
    f. have occurred ?4 times in the year before Visit 1 of study P261-401.
    g. have occurred at least once in the 3 months before Visit 1 of study P261-401.
    6. Subject has successfully completed study P261-401 and the subject and caregiver have demonstrated adequate compliance with P261-401 study procedures as determined by the investigator.
    7. Subject is not likely to conceive, as indicated by a ?yes? answer to at least 1 of the following questions:
    a. Is the subject a male?
    b. Is the subject a postmenopausal female as determined in Study P261-401?
    c. If sexually active or will become sexually active during the study, has the subject agreed to use an acceptable, double method of contraception during the entire study (except
    where local law or regulation differs; approval by USL or designee is required in such cases)?
    Examples of acceptable methods of contraception include the following:
    - A diaphragm with a condom.
    - An intrauterine device (IUD) with spermicide.
    - Hormonal methods (eg, high-dose birth control pills, Depo-Provera), an IUD or surgical sterilization (tubal ligation, etc.) used in combination with a barrier method (condom, diaphragm, or cervical cap).
    Note that hormonal contraception alone is not considered adequate for this study and must be used in combination with another method. The type of birth control used must be approved by the investigator or designee.
    8. Subject?s weight is 50 kg to 125 kg, inclusive, at Visit 1.
    1. El sujeto o el representante legal autorizado (RLA) del sujeto han otorgado su consentimiento informado por escrito y el sujeto ha otorgado su conformidad por escrito cuando así lo requiera la legislación local o las normas de la Junta de revisión institucional (JRI)/Comité Ético de Investigación Clínica independiente (CEIC).
    2. El sujeto tiene un(os) cuidador(es) competente(s), adulto(s)(> =18 años) que puede(n) reconocer y observar los episodios de crisis en racimo del sujeto, está(n) dispuesto(s) a ser formado(s) en los procedimientos del estudio y ha(n) otorgado su consentimiento informado por escrito; el (los) cuidador(es) debe(n) ser familiar(es), pareja, amigo(s) o RLA con una relación personal significativa con el sujeto.
    3. El sujeto tiene entre 14 y 66 años, inclusive, en la visita 1.
    4. El sujeto tiene un diagnóstico establecido de epilepsia parcial o generalizada.
    5. El sujeto tiene antecedentes documentados de crisis en racimo con un patrón que es observable, estereotipado
    y claramente diferenciable de otro tipo de crisis que no sean en racimo; las crisis en racimo del paciente
    deben:
    a. ser del mismo tipo que aprobó el revisor central en el estudio P261-401,
    b. tener una duración, como mínimo, de 10 minutos tras identificarse como crisis en racimo,
    c. no durar más de 6 horas,
    d. estar compuestas por crisis múltiples (>=2) parciales o generalizadas,
    e. estar establecidas > 3 meses antes de la visita 1 del estudio P261-401,
    f. haberse producido >=4 veces durante el año antes de la visita 1 del estudio P261-401,
    g. haberse producido, como mínimo, 1 vez en los 3 meses previos a la visita 1 del estudio P261-401.
    6. El sujeto ha completado con éxito el estudio P261-401 y el sujeto y el cuidador han demostrado un cumplimiento adecuado con los procedimientos del estudio P261-401 conforme los determinó el investigador.
    7. No es probable que el sujeto conciba, según lo indica una respuesta sí a, al menos, 1 de las siguientes preguntas:
    a. ¿El sujeto es hombre?
    b. ¿El sujeto es una mujer posmenopáusica conforme se determinó en el estudio P261-401?
    c. Si el sujeto es sexualmente activo o pasará a serlo durante el estudio, ¿ha aceptado el sujeto usar un método anticonceptivo doble aceptable durante la totalidad del estudio (excepto cuando la ley o la regulación local difiera, se requiere la aprobación de USL o de la persona que este designe en dichos casos)?
    Entre los ejemplos de métodos anticonceptivos aceptables se incluyen:
    - Diafragma con preservativo.
    - Dispositivo intrauterino (DIU) con espermicida.
    - Métodos hormonales (p. ej., píldoras anticonceptivas de dosis altas, Depo-Provera), DIU o esterilización quirúrgica (ligadura de trompas, etc.) usados en combinación con un método de barrera (preservativo, diafragma o cubierta cervical).
    Tenga en cuenta que los anticonceptivos hormonales solos no se consideran adecuados para este estudio y deben usarse en combinación con otro método. El método anticonceptivo usado debe estar aprobado por el investigador o por la persona que este designe.
    8. El peso del sujeto está entre 50 kg y 125 kg (inclusive), en la visita 1.
    E.4Principal exclusion criteria
    1. Subject experienced status epilepticus during or since the P261-401 study.
    2. Subject has a positive pregnancy test at Visit 1 or is pregnant, considering becoming pregnant, or is breastfeeding (female subjects only).
    3. Subject who, in the opinion of the investigator, is experiencing an ongoing, uncontrolled, clinically significant adverse event(s) from P261-401 at Visit 1 or did experience a clinically significant adverse event in study P261-401 that might prevent the subject from safely participating in the study.
    4. Subject has consumed any clinically significant CYP450 3A inhibitor/inducer, opioid, or other respiratory depressant, not including antiepileptic drugs (AEDs), within the required washout period before Visit 1
    5. Subjects using chronic benzodiazepine(s); chronic use is defined as use for 4 or more days in a 7-day period.
    6. Subject has a neurological disorder that is likely to progress in the next year.
    7. Subject has a history of acute narrow-angle glaucoma.
    8. Subject has a medical condition including uncontrolled cardiac, pulmonary, renal, hepatic, or gastrointestinal disease that could interfere with the study, subject safety/safety monitoring, or is not stable despite current therapy.
    9. Subject has severe chronic cardio-respiratory disease or the need for ambulatory oxygen.
    10. Subject has had psychogenic, non-epileptic seizure(s) during or since the P261-401 study.
    11. Subject has active suicidal plan or intent as determined by the Columbia-Suicide Severity Rating Scale (C-SSRS) at Visit 1 or medical history.
    12. Subject, in the investigator?s opinion, has met the criteria for a major depressive episode during or since the P261-401 study (criteria defined by the current edition of the Diagnostic and Statistical Manual of Mental Disorders).
    13. Subject has or has had psychosis during or since the P261-401 study, excluding postictal psychosis
    14. Subject has a history of drug or alcohol abuse during or since study P261-401.
    1. El sujeto experimentó un estado epiléptico durante o desde el estudio P261-401.
    2. El sujeto tiene una prueba de embarazo positiva en la visita 1 o, actualmente, está embarazada o en período de lactancia (mujeres únicamente).
    3. El sujeto que, a juicio del investigador, está experimentando acontecimiento(s) adverso(s) en curso, no controlado(s), clínicamente significativo(s) del estudio P261-401 en la visita 1 o experimentó un acontecimiento adverso significativo en el estudio P261-401 que quizá impida que su participación en este estudio sea segura.
    4. El sujeto ha consumido cualquier inhibidor/inductor del CYP450 3A clínicamente significativo, opioides otro depresor del sistema respiratorio, sin incluir fármacos antiepilépticos (FAE), dentro del período de lavado farmacológico antes de la visita 1 (véase el apéndice 1, Sustancias concomitantes prohibidas).
    5. Los sujetos que reciban benzodiacepina(s) de forma crónica; el uso crónico se define como la utilización durante 4 días o más en un período de 7 días.
    6. El sujeto tiene un trastorno neurológico que es probable que progrese en el próximo año.
    7. El sujeto tiene glaucoma de ángulo estrecho agudo.
    8. El sujeto tiene una afección médica que incluye enfermedad cardíaca, pulmonar, renal, hepática o gastrointestinal no controlada que podría interferir en el estudio, la seguridad del sujeto/la supervisión de la seguridad, o no es estable a pesar de la terapia actual.
    9. El sujeto tiene una enfermedad cardiorrespiratoria crónica grave o requiere oxígeno de forma ambulatoria.
    10. El sujeto ha tenido crisis psicógena(s) no epiléptica(s) durante o desde el estudio P261-401.
    11. El sujeto tiene tendencia al suicidio o ha llevado a cabo un intento, según se determina en la Columbia-Suicide Severity Rating Scale, C-SSRS (Escala de clasificación de la severidad del suicidio de Columbia) en la visita 1 o la historia clínica.
    12. El sujeto, según la opinión del investigador, ha cumplido los criterios de un episodio depresivo mayor durante o desde el estudio P261-401 (criterios definidos por la edición actual del Manual diagnóstico y estadístico de los trastornos mentales [Diagnostic and Statistical Manual of Mental Disorders]).
    13. El sujeto tiene o ha tenido psicosis durante o desde el estudio P261-401, excluida la psicosis postictal.
    14. El sujeto tiene antecedentes de abuso de drogas o de alcohol durante o desde el estudio P261-401.
    E.5 End points
    E.5.1Primary end point(s)
    The following safety endpoints will be summarized using the Safety Population:
    ? Occurrence of respiratory depression after study drug administration.
    ? Nature, frequency, and severity of AEs.
    ? Clinical laboratory values.
    ? OAA/S composite and sum scores.
    ? Vital sign measurements.
    ? Physical, nasal and neurological examinations.
    ? C-SSRS.
    The following efficacy endpoints will be summarized using the Efficacy Evaluable Population:
    ? The proportion of subjects who achieve Treatment Success for each study drug administration
    ? Kaplan-Meier analysis of time to cessation of seizure(s)
    Se resumirán los c. de valoración de seguridad por medio de la población de seguridad:
    - Aparición de depresión respiratoria tras administración del fármaco del estudio.
    - Naturaleza,frecuencia y severidad de los AA.
    - Valores de laboratorio clínico.
    - Suma de puntuaciones y puntuaciones compuestas de la escala OAA/S.
    - Medición de las constantes vitales.
    - Exámenes neurológicos,nasales y físicos.
    - C-SSRS.
    Se resumirán los siguientes criterios de valoración de eficacia por medio de la población de evaluación de la eficacia:
    - porcentaje de sujetos que alcanzan el éxito del tratamiento para cada dosis administrada del fármaco.
    - análisis Kaplan-Meier del tiempo hasta el cese de la(s) crisis
    E.5.1.1Timepoint(s) of evaluation of this end point
    ? Occurrence of respiratory depression after study drug administration
    ? Nature, frequency, and severity of AEs: Throughout the study
    ? Clinical laboratory values: Visit 1, Visit 2, Visit 3, Visit X and Final Visit
    ? OAA/S composite and sum scores after study drug administration
    ? Vital sign measurements: Visit 1, Visit 2, Visit 3, Visit X and Final Visit
    ? Physical, nasal and neurological examinations: Visit 1, Visit 2, Visit 3, Visit X and Final Visit
    ? C-SSRS: Visit 1, Visit 2, Visit 3, Visit X and Final Visit
    ? The proportion of subjects who achieve Treatment Success for each study drug administration: after study drug administration
    ? Kaplan-Meier analysis of up to 4 hours time to cessation of seizure(s): after study drug administration
    - Aparición de depresión respiratoria tras la administración del fármaco del estudio.
    - Naturaleza,frecuencia y severidad de los AA:a lo largo del estudio
    - Valores de laboratorio clínico:V1, V2, V3, VX y VFinal
    - Suma de puntuaciones y puntuaciones compuestas de la escala OAA/S después de la administración del fármaco
    - Medición de las constantes vitales: V1, V2, V3, VX y VFinal

    - Exámenes neurológicos, nasales y físicos: V1, V2, V3, VisitaX y V Final
    - C-SSRS: V1, V2, V3, VX y VFinal
    - El porcentaje de sujetos que alcanzan el éxito del tratamiento para cada dosis administrada del fármaco del
    estudio: después de la administración del fármaco
    - El análisis Kaplan-Meier de hasta 4 horas hasta el cese de la(s) crisis:después de la administración del fármaco
    E.5.2Secondary end point(s)
    Not applicable
    No aplicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    No aplicable
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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.8.2.4Number of treatment arms in the trial1
    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 EEA31
    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
    European Union
    Australia
    Canada
    Israel
    Ukraine
    United States
    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
    Last Visit Last Subject
    Ultima visita último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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 Yes
    F.1.1Number of subjects for this age range: 155
    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: 105
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 105
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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
    Adolescent patients aged 14 to 17 years.
    Subjects with Legal Representative
    Pacientes adolescentes de 14 a 17 años de edad.
    Sujetos con Representante Legal
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 155
    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 difference to the expected normal treatment of that condition
    Ninguna diferencia con el tratamiento normal esperado para esta condición
    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 Decision2012-05-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-04-12
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-02-22
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