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    Summary
    EudraCT Number:2021-002686-18
    Sponsor's Protocol Code Number:EP0162
    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:2021-10-19
    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 number2021-002686-18
    A.3Full title of the trial
    A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Outpatient, Parallel-Group Study to Assess the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures
    Estudio en doble ciego, aleatorizado, controlado con placebo, multicéntrico, en pacientes ambulatorios y de grupos paralelos, para evaluar la eficacia y la seguridad de Staccato® Alprazolam en participantes en el estudio de 12 o más años de edad con estereotipias prolongadas
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test the efficacy and safety of Staccato alprazolam in study participants 12 years of age and older with epilepsy
    Estudio para investigar la eficacia y la seguridad de Staccato® alprazolam en participantes en el estudio >=12 años de edad con epilepsia
    A.4.1Sponsor's protocol code numberEP0162
    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 SponsorUCB Biopharma SRL
    B.1.3.4CountryBelgium
    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 supportUCB Biopharma SRL
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUCB BIOSCIENCES GmbH
    B.5.2Functional name of contact pointClin Trial Reg & Results Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressAlfred-Nobel-Strasse 10
    B.5.3.2Town/ cityMonheim
    B.5.3.3Post code40789
    B.5.3.4CountryGermany
    B.5.6E-mailclinicaltrials@ucb.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 nameStaccato alprazolam
    D.3.2Product code UCB7538
    D.3.4Pharmaceutical form Inhalation powder
    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 INNalprazolam
    D.3.9.3Other descriptive nameALPRAZOLAM
    D.3.9.4EV Substance CodeSUB05370MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 Yes
    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 placeboInhalation powder
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment of stereotypical prolonged seizure
    Tratamiento de episodios de estereotipia prolongada
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10076333
    E.1.2Term Prolonged seizure
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Comparison of the success of a single administration of Staccato alprazolam compared with placebo both in rapidly terminating a seizure episode within 90 seconds and with no recurrence of seizure(s) up to 2 hours after investigational medicinal product (IMP) administration.
    Comparar el éxito de una sola administración de Staccato® alprazolam frente a placebo en cuanto a la rápida conclusión de un episodio epiléptico en el plazo de los 90 segundos siguientes a la administración del IMP y sin recurrencia del episodio(s) en el plazo de las 2 horas siguientes
    E.2.2Secondary objectives of the trial
    - Comparison of the success of a single administration of Staccato alprazolam compared with placebo both in rapidly terminating a seizure episode within 90 seconds and with no recurrence of seizure(s) up to 4 hours after IMP administration
    - Comparison of the success of a single administration of Staccato alprazolam compared with placebo both in rapidly terminating a seizure episode within 90 seconds and with no recurrence of seizure(s) up to 6 hours after IMP administration
    - Comparison of the time from IMP administration to cessation of the treated seizure between Staccato alprazolam and placebo
    - Evaluate the pulmonary safety of a single dose of Staccato alprazolam compared with placebo
    - Comparison of the occurrence of subsequent seizure(s) up to 2 hours after IMP administration between Staccato alprazolam and placebo
    - Comparar el éxito de una sola administración de Staccato® alprazolam frente a placebo en cuanto a la rápida conclusión de un episodio epiléptico en el plazo de los 90 segundos siguientes a la administración del IMP y sin recurrencia del episodio(s) en el plazo de las 4 horas siguientes
    - Comparar el éxito de una sola administración de Staccato® alprazolam frente a placebo en cuanto a la rápida conclusión de un episodio epiléptico en el plazo de los 90 segundos siguientes a la administración del IMP y sin recurrencia del episodio(s) en el plazo de las 6 horas siguientes
    - Comparar el tiempo desde la administración del IMP hasta el cese del episodio tratado con Staccato® alprazolam y con placebo
    - Evaluar la seguridad pulmonar de una sola dosis de Staccato® alprazolam en comparación con placebo
    - Comparar la presentación de episodios posteriores hasta transcurridas 2 horas desde la administración del IMP entre Staccato® alprazolam y placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Participant must be ≥12 years of age at the Baseline/Randomization Visit
    - Participant must have a caregiver ≥18 years of age at the Screening Visit; the caregiver(s) must be able to recognize and observe the participant’s seizures
    - Participants with an established diagnosis of focal or generalized epilepsy or combined focal and generalized epilepsy with a documented history of stereotypical episodes of prolonged seizures that includes at least 1 of the following:
    a) Generalized seizure episodes starting with a flurry of absence seizures or myoclonic seizures with a minimum total duration of 5 minutes
    b) Episodes of a focal seizure with a minimum duration of 3 minutes
    c) Episodes of a focal seizure or myoclonic seizure for at least 90 seconds followed by a generalized/bilateral tonic-clonic seizure with a minimum total duration of 3 minutes
    - Prior to the Screening Visit, participant has experienced ≥4 stereotypical episodes of prolonged seizures in the past 6 months, and the last 2 stereotypical episodes of prolonged seizures must have occurred within the 3 months prior to the Screening Visit
    - Male and female participants:
    a) A male participant must agree to use contraception during the Treatment Period and for at least 7 days after investigational medicinal product (IMP) administration
    b) A female participant is eligible to participate if she is not pregnant, not breastfeeding, and:
    i) Not a woman of childbearing potential (WOCBP)
    OR
    ii) A WOCBP who agrees to follow the contraceptive during the Treatment Period and for at least 30 days after IMP administration
    - Participant is capable of giving signed informed consent (or giving assent, where required). The informed consent form (ICF), or a specific assent form, where required, will be signed and dated by minors
    - The participant’s caregiver(s) must be capable of giving signed informed consent), which includes compliance with the requirements and restrictions listed in the ICF, the protocol, and the individualized participant management plan (iPMP)
    - El participante deberá tener >=12 años de edad en la Visita Basal/de Aleatorización.
    - El participante deberá tener un cuidador >=18 años de edad en la Visita de Selección; el cuidador(es) deberá ser capaz de reconocer y observar los episodios epilépticos del participante.
    - Participante con diagnóstico establecido de epilepsia focal o generalizada o de epilepsia focal y generalizada combinadas, con historia documentada de episodios de estereotipia prolongados que incluyen como mínimo 1 de lo siguiente:
    a) Episodios generalizados que se inician con un racimo de crisis de ausencia o de mioclonías con una duración total mínima de 5 minutos
    b) Episodios de crisis focales con una duración mínima de 3 minutos
    c) Episodios de crisis focales o mioclónicas de como mínimo 90 segundos seguidas por crisis generalizadas/bilaterales tónico-clónicas con una duración total mínima de 3 minutos
    - Antes de la Visita de Selección, el participante ha experimentado >=4 episodios de estereotipia prolongada en los 6 últimos meses, y los 2 últimos episodios de estereotipia prolongada han tenido lugar en los 3 meses anteriores a la Visita de Selección.
    - Participantes de ambos sexos:
    a) Los varones deberán estar de acuerdo en observar medidas anticonceptivas durante el Periodo de Tratamiento Ambulatorio y como mínimo los 7 días siguientes a la administración del IMP
    b) Las mujeres serán elegibles para participar si no están embarazadas o practicando la lactancia natural y:
    i)No se trata de una mujer potencialmente fértil (woman of childbearing potential, WOCBP)
    O BIEN
    ii) Se trata de una WOCBP que está de acuerdo en seguir las recomendaciones acerca de anticoncepción durante el Periodo de Tratamiento Ambulatorio y como mínimo los 30 días siguientes a la administración del IMP.
    - Participante que es capaz de firmar el documento de consentimiento informado (o de dar su asentimiento, según proceda). Los menores firmarán y fecharán el ICF o el documento específico de asentimiento, según proceda.
    - Cuidador(es) del participante que es capaz de firmar el ICF, lo que incluye el cumplimiento de los requisitos y restricciones que se señalan en el ICF, el protocolo y el plan de manejo individualizado del participante (iPMP).
    E.4Principal exclusion criteria
    - Participant has a history of convulsive status epilepticus in the 8 weeks prior to the Screening Visit
    - Participant has a history or presence of known nonepileptic seizures which cannot be distinguished from qualifying epileptic seizures
    - Participant has a clinically significant known airway hypersensitivity (eg, bronchospasm to known allergens, such as pollen, animals, or food) and/or acute respiratory signs/symptoms (eg, shortness of breath, wheezing on lung auscultation)
    - Participant has a clinically significant chronic pulmonary disorder (eg, asthma, chronic obstructive pulmonary disease, restrictive lung diseases [including idiopathic pulmonary fibrosis]) and/or recent history or presence of hemoptysis or pneumothorax
    - Participant has a condition for which oral alprazolam is contraindicated (eg, myasthenia gravis, severe respiratory insufficiency, and sleep apnea syndrome)
    - Chronic use of benzodiazepines for more than 3 days within a period of 7 days will be allowed for approximately 30 % of study participants
    - Participant is taking any drug that is a strong CYP3A4 inhibitor, including azole antifungal agents (ketoconazole and itraconazole) and nefazodone
    - Participant is taking any opioids (eg, fentanyl, oxycodone, morphine) or sedative hypnotics on a chronic basis
    - Participant is taking nonselective beta blockers (eg, propranolol, nadolol, and timolol) on a chronic basis
    - Participant has an forced expiratory volume in 1 second (FEV1) <80 % of predicted FEV1 as measured via spirometry at the Screening Visit
    - Participant has an oxygen saturation <95 % for greater than 30 seconds during the Screening Visit
    - Participant cannot actuate the Staccato training device at the Screening Visit and the Baseline/Randomization Visit
    - Participante que tiene antecedente de status epilepticus convulsivo en las 8 semanas previas a la Visita de Selección.
    - Participante que tiene historia o presencia de crisis no epilépticas conocidas que no pueden diferenciarse de las crisis epilépticas cualificadoras.
    - Participante que tiene una hipersensibilidad conocida de las vías aéreas clínicamente importante (por ejemplo, broncoespasmo a alérgenos conocidos, como polen, animales o alimentos) y/o signos/síntomas respiratorios agudos (por ejemplo, disnea, ruidos torácicos en la auscultación pulmonar).
    - Participante que tiene un trastorno pulmonar crónico clínicamente importante (por ejemplo, asma, enfermedad pulmonar obstructiva crónica, enfermedad pulmonar restrictiva [incluida la fibrosis pulmonar idiopática]) y/o historia reciente o presencia de hemoptisis o neumotórax.
    - Participante que presenta un proceso para el que está contraindicado el alprazolam oral (por ejemplo, miastenia gravis, insuficiencia respiratoria severa y síndrome de apnea del sueño).
    - Se permitirá el uso crónico de benzodiacepinas durante más de 3 días en un periodo de 7 días en aproximadamente el 30% de los participantes en el estudio.
    - Participante que está en tratamiento con un medicamento que es un inhibidor potente de la isoenzima 3A4 del citocromo P450 (CYP), incluidos los azoles antifúngicos (ketoconazol e itraconazol) y la nefazodona.
    - Participante que está en tratamiento crónico con opioides (por ejemplo, fentanilo, oxicodona, morfina) o hipnóticos sedantes.
    - Participante que está en tratamiento crónico con betabloqueantes no selectivos (por ejemplo, propranolol, nadolol y timolol).
    - Participante que presenta un volumen espiratorio forzado en un 1segundo (forced expiratory volume in 1 second, FEV1) <80% del predicho en la espirometría de la Visita de Selección.
    - Participante con una saturación de oxígeno <95% durante más de 30 segundos en la Visita de Selección.
    - Participante que no es capaz de manejar el dispositivo Staccato® de formación en la Visita de Selección y la Visita Basal/de Aleatorización.
    E.5 End points
    E.5.1Primary end point(s)
    Treatment success for the treated seizure with no recurrence after 2 hours
    Éxito del tratamiento del episodio tratado sin recurrencia en el plazo de las 2 horas siguientes
    E.5.1.1Timepoint(s) of evaluation of this end point
    From start of IMP treatment through 2 hours
    Desde el comienzo de la administración del IMP en el plazo de las 2 horas siguientes
    E.5.2Secondary end point(s)
    1. Treatment success for treated seizure with no recurrence after 4 hours
    2. Treatment success for treated seizure with no recurrence after 6 hours
    3. Time from IMP administration to cessation of the treated seizure
    4. Frequency of respiratory treatment emergent adverse events (TEAEs)
    5. Number of subsequent seizure(s) up to 2 hours after IMP administration
    6. Time to first subsequent seizure up to 2 hours after IMP administration
    1. Éxito del tratamiento del episodio tratado sin recurrencia en el plazo de las 4 horas siguientes
    2. Éxito del tratamiento del episodio tratado sin recurrencia en el plazo de las 6 horas siguientes
    3. Tiempo desde la administración del IMP hasta el cese del episodio tratado
    4. Freguencia de TEAEs respiratorios
    5. Número de episodio(s) posteriores hasta transcurridas 2 horas desde la administración del IMP
    6. Tiempo hasta el primer episodio posterior en el plazo de las 2 horas siguientes a la administración del IMP
    E.5.2.1Timepoint(s) of evaluation of this end point
    1: From start of IMP treatment through 4 hours
    2&3: From start of IMP treatment through 6 hours
    4: From start of IMP treatment up to the Safety Follow-up Visit (Week 19)
    5&6: From start of IMP treatment through 2 hours
    1: Desde el comienzo de la administración del IMP en el plazo de las 4 horas siguientes
    2&3: Desde el comienzo de la administración del IMP en el plazo de las 6 horas siguientes
    4: Desde el comienzo de la administración del IMP hasta la visita de Seguimiento de Seguridad (Semana 19)
    5&6: Desde el comienzo de la administración del IMP en el plazo de las 2 horas siguientes
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tolerabilidad
    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 Yes
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA43
    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
    Australia
    Japan
    Ukraine
    United States
    Bulgaria
    France
    Germany
    Hungary
    Italy
    Poland
    Spain
    United Kingdom
    Czechia
    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
    LVLS
    última 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 months5
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days21
    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: 35
    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: 35
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 78
    F.4.2.2In the whole clinical trial 200
    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)
    After completing the study, eligible study participants will be allowed to enroll in an open-label extension (OLE) study (EP0165).
    Una vez completado el estudio, los participantes en el estudio elegibles podrán entrar en un estudio de extensión abierto (EP0165).
    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 Decision2022-02-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-19
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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