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    Summary
    EudraCT Number:2021-002686-18
    Sponsor's Protocol Code Number:EP0162
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-10-06
    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 ConcernedFrance - ANSM
    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
    Étude multicentrique, randomisée, en double aveugle, contrôlée par placebo, en ambulatoire, en groupes parallèles, visant à évaluer l’efficacité et la sécurité d’emploi de Staccato alprazolam chez des participants à l’étude âgés de 12 ans et plus présentant des crises stéréotypées prolongées
    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
    Étude visant à évaluer l’efficacité et la sécurité d’emploi de Staccato alprazolam chez des participants à l’étude âgés de ≥ 12 ans présentant épilepsie
    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
    Traitement de la crise stéréotypée prolongée
    E.1.1.1Medical condition in easily understood language
    Epilepsy
    Épilepsie
    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.
    Comparer le succès d’une administration unique de Staccato alprazolam par rapport au placebo pour arrêter rapidement un épisode de crise dans les 90 secondes après l’administration du ME et éviter une récidive de la(des) crise(s) jusqu’à 2 heures après l’administration du ME
    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
    -Comparer le succès d’une administration unique de Staccato alprazolam par rapport au placebo pour arrêter rapidement un épisode de crise dans les 90 secondes après l’administration du ME et éviter une récidive de la(des) crise(s) jusqu’à 4 heures après l’administration du ME
    -Comparer le succès d’une administration unique de Staccato alprazolam par rapport au placebo pour arrêter rapidement un épisode de crise dans les 90 secondes après l’administration du ME et éviter une récidive de la(des) crise(s) jusqu’à 6 heures après l’administration du ME
    -Comparer le délai entre l’administration du ME et l’arrêt de la crise traitée, sous Staccato alprazolam et sous placebo
    -Évaluer la sécurité d’emploi, au niveau pulmonaire, d’une dose unique Staccato alprazolam par rapport au placebo
    -Comparer la survenue de crise(s) ultérieure(s) jusqu’à 2 heures après l’administration du ME, entre Staccato alprazolam et le 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)
    - Les participants doivent être âgés de ≥ 12 ans au à la visite d’inclusion/randomisation.
    - Le(la) participant(e) doit être accompagné(e) d’un aidant âgé de ≥18 ans à la visite de sélection ;l’aidant ou le aidants doi(ven)t être capables de reconnaître et d’observer les crises du(de la) participant(e).
    - Participants ayant un diagnostic établi d’épilepsie focale ou généralisée ou d’une épilepsie associant
    des crises focales et généralisées avec antécédents documentés d’épisodes stéréotypés de crises
    prolongées incluant au moins 1 des éléments suivants :
    a) Épisodes de crises généralisées commençant par une série de crises de type absence ou crises
    myocloniques d’une durée totale minimum de 5 minutes
    b) Épisodes de crise focale d’une durée minimum de 3 minutes
    c) Épisodes de crise focale ou de crise myoclonique pendant au moins 90 secondes, suivis d’une crise
    généralisée/tonico-clonique bilatérale d’une durée totale minimum de 3 minutes
    - Avant la visite de sélection, antécédents de ≥ 4 épisodes de crises stéréotypées prolongées au cours des 6 mois précédents, avec survenue des 2 derniers épisodes de crises stéréotypées prolongées dans les 3 mois avant la visite de sélection.
    - Participants hommes et femmes :
    a) Un homme participant à l’étude doit accepter d’utiliser les moyens de contraception recommandés
    pendant la période de traitement en ambulatoire et pendant au moins 7 jours après l’administration
    du ME et ne pas donner de sperme pendant cette période.
    b) Une femme susceptible de participer à l’étude est éligible pour participer si elle n’est pas enceinte,
    n’allaite pas et qu’au moins une des conditions suivantes est applicable :
    )i La participante n’est pas une femme en âge de procréer (FAP)
    OU
    ii)La participante est une FAP qui accepte de suivre les recommandations relatives à la
    contraception pendant la période de traitement en ambulatoire et pendant au moins 30 jours
    après l’administration du ME.
    - Le(la) participant(e) a la capacité de donner son consentement éclairé signé (FCE) (ou son assentiment, lorsque cela est nécessaire), ce qui inclut le respect des exigences et restrictions indiquées dans le FCE, le protocole et l’iPMP. Le FCE ou un formulaire spécifique pour les mineurs (assentiment), le cas échéant, sera signé et daté par les mineurs.
    - Le(s) aidant(s) doi(ven)t avoir la capacité de donner leur FCE signé, ce qui inclut le respect des
    exigences et restrictions indiquées dans le FCE, le protocole et l’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
    -Antécédents d’état de mal épileptique au cours des 8 semaines ayant précédé la visite de sélection.
    -Antécédents ou présence de convulsions non épileptiques connues ne pouvant pas être distinguées des crises épileptiques qualifiantes.
    -Hypersensibilité connue cliniquement significative des voies aériennes (par exemple, bronchospasme en réaction à des allergènes connus, tels que le pollen, les aliments ou les aliments) et/ou signes/symptômes respiratoires aigus (par exemple, essoufflement, sifflements respiratoires à
    l’auscultation pulmonaire).
    -Pneumopathie chronique cliniquement significative (par exemple, asthme, bronchopneumopathie
    chronique obstructive, pneumopathie restrictive [y compris fibrose pulmonaire idiopathique]) et/ou
    antécédents récents ou présence d’une hémoptysie ou d’un pneumothorax
    - Présence d’une pathologie constituant une contre-indication à l’administration d’alprazolam oral (par exemple, myasthénie grave, insuffisance respiratoire sévère, et syndrome d’apnées du sommeil).
    - L’utilisation chronique de benzodiazépines pendant plus de 3 jours au cours d’une période de 7 jours sera autorisée pour environ 30 % des participants à l’étude.
    - Prise d’un médicament constituant un inhibiteur puissant du cytochrome P450 (CYP) 3A4, y compris les agents antifongiques azolés (kétoconazole et itraconazole) et néfazodone.
    - Prise d’opiacés (par exemple, fentanyl, oxycodone, morphine) ou de sédatifs hypnotiques de manière chronique
    - Prise de bêta-bloquants non sélectifs (par exemple, propranolol, nadolol et timolol) de manière chronique
    - Volume expiratoire maximum seconde (VEMS) < 80 % du VEMS prédit, mesuré par spirométrie à la visite de sélection.
    - Saturation en oxygène < 95 % (ou inférieure à la normale dans les régions ayant une altitude > 2500 mètres) pendant plus de 30 secondes au cours de la visite de sélection. En cas de valeurs en dehors des valeurs normales, 1 nouvelle analyse sera autorisée. Si les résultats sont à nouveau anormaux, le(la) participant(e) à l’étude sera exclu(e).
    - Incapacité du(de la) participant(e) à faire fonctionner le dispositif de formation Staccato à la visite de sélection et à la visite d’inclusion/randomisation.
    E.5 End points
    E.5.1Primary end point(s)
    Treatment success for the treated seizure with no recurrence after 2 hours
    Succès du traitement pour la crise traitée, et absence de récidive de la(des) crise(s) jusqu’à 2 heures
    E.5.1.1Timepoint(s) of evaluation of this end point
    From start of IMP treatment through 2 hours
    Du début du traitement jusqu'à 2 heures après l’administration du ME
    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.Succès du traitement pour la crise traitée, et absence de récidive de la(des) crise(s) jusqu’à 4 heures
    2.Succès du traitement pour la crise traitée, et absence de récidive de la(des) crise(s) jusqu’à 6 heures
    3.Délai entre l’administration du ME et l’arrêt de la crise traitée
    4.Fréquence des EIAT respiratoires
    5.Nombre de crise(s) ultérieure(s) jusqu’à 2 heures après l’administration du ME
    6. Délai avant la survenue de la première crise ultérieure jusqu’à 2 heures après l’administration du ME
    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: Du début du traitement jusqu'à 4 heures après l’administration du ME
    2&3: Du début du traitement jusqu'à 6 heures après l’administration du ME
    4: Du début du traitement jusqu'à visite de suivi de la sécurité d’emploi (semaine 19)
    5&6: Du début du traitement jusqu'à 2 heures après l’administration du ME
    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
    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 concerned8
    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
    la dernière visite du dernier patient
    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 days9
    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 state15
    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).
    Après avoir terminé l'étude, les participants à l'étude éligibles seront autorisés à s'inscrire à une étude d'extension en ouvert (OLE) (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 Decision2022-01-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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