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    Summary
    EudraCT Number:2011-001318-32
    Sponsor's Protocol Code Number:P261-401
    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:2011-08-12
    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 number2011-001318-32
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled Study of
    the Safety and Efficacy of Intranasal Midazolam (USL261) in
    the Outpatient Treatment of Subjects with Seizure Clusters
    ARTEMIS-1: Acute Rescue Therapy in Epilepsy with
    Midazolam Intranasal Spray-1
    Estudio aleatorizado, doble ciego, controlado con placebo, sobre la seguridad y la eficacia de midazolam intranasal (USL261) en el tratamiento ambulatorio de sujetos con crisis en racimo
    ARTEMIS-1: Terapia Aguda de Rescate para la Epilepsia con Nebulizador Intranasal de Midazolam-1
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Not applicable
    No aplica
    A.3.2Name or abbreviated title of the trial where available
    ARTEMIS-1: Acute Rescue Therapy in Epilepsy with Midazolam Intranasal Spray-1
    ARTEMIS-1: Terapia Aguda de Rescate para la Epilepsia con Nebulizador Intranasal de Midazolam-1
    A.4.1Sponsor's protocol code numberP261-401
    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, LLC
    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+44 870 242 0780
    B.5.5Fax number+44 870 242 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboNasal spray, solution in single-dose container
    D.8.4Route of administration of the placeboIntranasal use (Noncurrent)
    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 14.0
    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 efficacy of USL261 compared with that of IN placebo for the outpatient
    treatment of seizure clusters based on Treatment Success, which is defined as achieving both of
    the following:
    ? Termination of seizure(s) within 10 minutes after study drug administration, and
    ? No recurrence of seizure(s) within 4 hours after study drug administration

    To evaluate the safety and tolerability of USL261 for the treatment of seizure clusters using the
    following assessments:
    ? AEs
    ? Alertness/Sedation Sum Score and Composite Scores at the end of the seizure cluster
    (within 6 hours after study drug administration) as recorded on the caregiveradministered
    OAA/S
    ? 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)
    ? Clinical laboratory tests
    ? Requirement for unscheduled ER or EMS visit
    Evaluar la eficacia de USL261 en comparación con placebo intranasal (IN) para el tratamiento ambulatorio de crisis en racimo en función del éxito del tratamiento

    Evaluar la seguridad y la tolerabilidad de USL261 para el tratamiento de crisis en racimo

    Pueden encontrar los objetivos principales del estudio en la sección 2 del protocolo
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of USL261 compared with that of IN placebo for the outpatient
    treatment of seizure clusters using the following:
    ? Occurrence of seizure(s) within 6 hours after study drug administration
    ? Time to next seizure after study drug administration
    ? Frequency of seizure(s) within 6 hours after study drug administration
    Evaluar la eficacia de USL261 en comparación con placebo IN para el tratamiento ambulatorio de crisis en racimo mediante lo siguiente:
    ? Aparición de la(s) crisis en las 6 horas posteriores a la administración del fármaco del estudio
    ? Tiempo hasta la próxima crisis después de la administración del fármaco del estudio
    ? Frecuencia de la(s) crisis en las 6 horas posteriores a la administración del fármaco del estudio
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ? Subject has a competent, adult caregiver who can recognize and observe the subject?s seizure cluster episodes
    ? Subject has an established diagnosis of partial or generalized epilepsy that includes all of the following:
    o A documented history of seizure clusters lasting > 10 minutes and < 6 hours, with a pattern that is observable, stereotyped, and recognizably different from the subject?s other non-cluster seizure activity, if any;
    o A seizure cluster pattern composed of multiple (? 2) partial or generalized seizures;
    o A seizure cluster pattern established > 3 months before Visit 1;
    o A frequency of ? 4 seizure clusters during the year before Visit 1;
    o At least 1 seizure cluster occurring ? 3 months before Visit 1;
    o Seizure cluster pattern is confirmed by a central reviewer
    ? Currently on a stable dosing regimen of AEDs since Visit 1 and for ? 7 days before Visit 2, with or without intermittent use of benzodiazepines at a constant dose
    ? El sujeto tiene un(os) cuidador(es) competente(s) que puede(n) reconocer y observar los episodios de crisis en racimo del sujeto
    ? El sujeto tiene un diagnóstico establecido de epilepsia parcial o generalizada que incluye todo lo siguiente:
    -Antecedentes documentados de crisis en racimo que duran >10 minutos y <6 horas, con un patrón que es observable, estereotipado y claramente diferenciable de otro tipo de crisis del sujeto sin ser en racimo, si la hubiera.
    -Un patrón de crisis en racimo compuesto por crisis múltiples (?2) parciales o generalizadas.
    -Un patrón de crisis en racimo establecido >3 meses antes de la visita 1
    -Una frecuencia de ?4 crisis en racimo durante el año antes de la visita 1
    -Al menos 1 crisis en racimo que ocurre ?3 meses antes de la visita 1
    -El patrón de crisis en racimo descrito anteriormente está confirmado por un revisor central
    ? El sujeto está recibiendo un régimen de FAE que ha permanecido estable (es decir, sin cambios en el tipo ni dosis del FAE) desde la visita 1 y durante ?7 días antes de la visita 2, con o sin uso intermitente de benzodiacepinas a una dosis constante
    E.4Principal exclusion criteria
    ? Subject has a neurological disorder that is likely to progress in the next year
    ? Subject has had psychogenic, non-epileptic seizure(s) within the 5 years before Visit 1
    ? Subject has a history of their stereotypical seizure cluster progressing to status epilepticus within the 2 years before Visit 1 or has a history of seizure clusters progressing to status epilepticus despite therapeutic intervention
    ? Subject has a history of acute narrow-angle glaucoma.
    ? Subject has had an active suicidal plan/intent or active suicidal thoughts in the 6 months before Visit 1 or any lifetime suicide attempt
    ? Subject is taking felbamate for less than 18 consecutive months before Visit 1or has discontinued felbamate within 30 days before Visit 1
    ? Subject is currently taking or has taken vigabatrin within 1 year before Visit 1
    ? Subject has taken vigabatrin in the past and has either no documentation of visual field exam or dcumentation on an abnormal
    visual field exam
    ? Subject is currently using a vagal nerve stimulator (VNS) unless the device has been implanted for at least 6 months and the settings have
    not changed within 4 weeks before Visit 1.
    ? El sujeto tiene un trastorno neurológico que es probable que progrese en el próximo año
    ? El sujeto ha tenido crisis psicógena(s) no epiléptica(s) en los 5 años anteriores a la visita 1
    ? El sujeto tiene antecedentes de crisis en racimo estereotípica que progresa a un estatus epiléptico en el plazo de 2 años antes de la visita 1, o tiene antecedentes de crisis en racimo que progresan a un estatus epiléptico a pesar de una intervención terapéutica.
    ? El sujeto tiene glaucoma de ángulo estrecho agudo
    ? El sujeto ha tenido un plan/intención suicida activo/a o pensamientos suicidas activos en los 6 meses anteriores a la visita 1 o cualquier intento suicida en su vida
    ? El sujeto actualmente toma felbamato durante <18 meses consecutivos antes de la visita 1 o ha interrumpido el felbamato en el plazo de 30 días antes de la visita 1
    ? El sujeto toma o ha tomado vigabatrina en el plazo de 1 año antes de la visita 1
    ? El sujeto ha tomado vigabatrina y no tiene documentación del examen de campo visual o tiene documentación de un examen de campo visual anormal
    ? El sujeto usa actualmente un estimulador del nervio vago, a menos que el dispositivo lleve implantado como mínimo 6 meses y los ajustes no hayan cambiado en las 4 semanas anteriores a la visita 1
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the proportion of subjects who meet the criteria for Treatment Success.
    El criterio de valoración de eficacia principal es la proporción de sujetos que cumplen los criterios de éxito del tratamiento
    E.5.1.1Timepoint(s) of evaluation of this end point
    Treatment Success is a composite measure of efficacy that will be assessed based upon the first seizure cluster treated during the Comparative Phase. Treatment Success is defined as achieving the following:
    ? Termination of seizure(s) within 10 minutes after study drug administration, and
    ? No recurrence of seizure(s) within 4 hours after study drug administration
    El éxito del tratamiento es una medida compuesta de la eficacia que se evaluará en función de la primera crisis en racimo tratada durante la Fase Comparativa. El éxito del tratamiento se define como lograr lo siguiente:
    ? finalización de la(s) crisis en el plazo de 10 minutos después de la administración del fármaco del estudio; y
    ? falta de recurrencia de la(s) crisis en el plazo de 4 horas después de la administración del fármaco del estudio
    E.5.2Secondary end point(s)
    ? Proportion of subjects with occurrence of seizure(s) within 6 hours after administration of double-blind study drug
    ? Time to next seizure after study drug administration
    ? Frequency of seizure(s) within 6 hours after administration of study drug
    ? Proporción de sujetos con aparición de crisis en las 6 horas posteriores a la administración del fármaco del estudio doble ciego
    ? Tiempo hasta la próxima crisis después de la administración del fármaco del estudio
    ? Frecuencia de la(s) crisis en las 6 horas posteriores a la administración del fármaco del estudio
    E.5.2.1Timepoint(s) of evaluation of this end point
    ? Proportion of subjects with occurrence of seizure(s): Within 6 hours after administration of double-blind study drug
    ? Time to next seizure after study drug administration: At occurrence of next seizure after study drug administration
    ? Frequency of seizure(s) within 6 hours after administration of study drug: within 6 hours after administration of study drug
    ? Proporción de sujetos con aparición de crisis: en las 6 horas posteriores a la administración del fármaco del estudio doble ciego
    ? Tiempo hasta la próxima crisis después de la administración del fármaco del estudio: en la aparición de la próxima crisis después de la administración del fármaco del estudio
    ? Frecuencia de la(s) crisis en las 6 horas posteriores a la administración del fármaco del estudio: en las 6 horas posteriores a la administración del fármaco 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 Yes
    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 Yes
    E.8.1.7.1Other trial design description
    fase abierta de prueba de dosis, seguida de la fase comparativa doble ciega
    open-label test-dose phase, followed by double-blind comparative phase
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    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
    Argentina
    Australia
    Canada
    Israel
    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 Ultimo Sujeto
    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 months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    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
    pacientes adolescentes de 14 a 17 años
    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
    Sin diferencias al tratamiento normal esperado para esa 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 Decision2011-11-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-06
    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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