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    Summary
    EudraCT Number:2019-000882-19
    Sponsor's Protocol Code Number:P160949J
    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:2019-08-08
    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 number2019-000882-19
    A.3Full title of the trial
    Efficacy of add-on PEramPanel in focal motor Status epilepticus
    Efficacité du PEramPanel (PER) dans le traitement de l'état de mal épileptique focal moteur
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    NA
    A.3.2Name or abbreviated title of the trial where available
    PEPSI
    A.4.1Sponsor's protocol code numberP160949J
    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 SponsorASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMinistère des Solidarités et de la Santé
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    B.5.2Functional name of contact pointDRCI Hôpital St Louis
    B.5.3 Address:
    B.5.3.1Street Address1 avenue Claude Vellefaux
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.6E-mailyannick.vacher@aphp.fr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Fycompa
    D.2.1.1.2Name of the Marketing Authorisation holderEisai Europe Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameFycompa
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPERAMPANEL
    D.3.9.1CAS number 380917-97-5
    D.3.9.3Other descriptive namePERAMPANEL
    D.3.9.4EV Substance CodeSUB32160
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with a focal motor status epilepticus
    Patients présentant un état de mal épileptique focal moteur
    E.1.1.1Medical condition in easily understood language
    NA
    NA
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To test the add-on efficacy of enteral administration of perampanel (versus placebo) to the conventional second line intravenous antiepileptic drug, on seizure cessation, measured within the 2 and 3 hours after the administration of perampanel or placebo (between H2 and H3), in benzodiazepine-resistant focal motor status epilepticus.
    Tester l’efficacité complémentaire de l’administration entérale du pérampanel (versus placébo), à une seconde ligne conventionnelle de traitement antiépileptique intraveineux sur l’arrêt des crises, mesuré dans les 2 et 3 heures après l’administration du perampanel ou du placébo (entre H2 et H3), dans l’état de mal focal moteur résistant aux benzodiazépines.
    E.2.2Secondary objectives of the trial
    To evaluate the add-on efficacy of enteral administration of PER to the conventional 2nd line IV antiepileptic (AE) drug, on the:
    •Rate of seizure cessation
    •Time to seizure cessation
    •Time to seizure cessation,without the use of an additional 2nd line IV AE drug
    •Need for additional 2nd line AE drugs to control the SE
    •Need for endotracheal intubation for general anesthesia and for disorder of consciousness
    •% of patients with altered consciousness
    •Duration of overall hospitalization and in ICU/step down unit
    •Rate of seizure recurrence and SE recurrence in patients with seizure cessation of at least 1h
    •% of patients with secondary generalized seizures and number of secondary generalized seizures
    •Progression to a convulsive generalized SE
    •Mortality rate, the GOS and return to previous neurological state
    •Number of adverse events and their severity
    •% of patients with seizure cessation within 1h after the administration of the conventional 2nd line IV AE drug
    Evaluer l'efficacité complémentaire de l'adm. entérale du PER à la 2nde ligne conventionnelle de traitement antiépileptique (AE) sur:
    -Tx d’arrêt de crise
    -Délai d’arrêt des crises
    -Délai d'arrêt des crises sans recourir à une 2nde ligne de tt AE IV supplémentaire
    -Besoin d’une 2nde ligne de tt AE supplémentaire pour contrôler l'EME
    -Besoin d'intubation endotrachéale pour AG et pour un trouble de la vigilance
    -% de patients présentant une altération de la vigilance
    -Durée de l'hospit. globale et en USI/unité de soins continus
    -Tx de récidive des crises et de l'EME chez les patients en arrêt de crise d'au moins 1h
    -% de patients avec des crises 2ndaires généralisées et le nombre de crises 2ndaires généralisées
    -Progression vers un EME convulsif généralisé
    -Tx de mortalité, l'échelle de devenir de Glasgow et le retour à l'état neuro. antérieur
    -Nb d'EI et leur gravité
    -% de patients avec arrêt des crises dans l’heure après adm. de la 2nde ligne conventionnelle de tt AE IV
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients aged 18 years or above including the protected adults , with a focal motor status epilepticus, defined by prominent clinically objective focal motor symptoms (clonic, tonic, myoclonic, adversive or oculoclonic), lasting for more than 10 minutes before any treatment or repeated focal motor seizures during this period (≥ 4 seizures in 10 min).
    2. The focal motor status continues (or patients show ≥ 2 focal motor seizures) 5 minutes after the beginning of administration of benzodiazepines,
    3. Affiliation to a French social security system (recipient or assign) excluding AME
    1. Patients âgés de 18 ans ou plus, présentant un état de mal épileptique focal moteur, défini par des symptômes moteurs focaux cliniquement objectivables (cloniques, toniques, myocloniques, versifs ou oculocloniques), qui durent plus de 10 minutes avant tout traitement ou par des crises motrices se répétant durant cette période (≥ 4 crises en 10 min).
    2. L’état de mal focal moteur (ou le patient présente ≥ 2 crises focales motrices) persiste au-delà de 5 minutes après le début d’une administration de benzodiazépines.
    3. Affiliation à la sécurité sociale Française (bénéficiaire ou ayant droit) excluant l’Aide Médicale de l’Etat.
    E.4Principal exclusion criteria
    1. Known severe liver (Factor V <50 %) or kidney (glomerular filtration rate : 15-29 ml/min/1,72 m2) insufficiency,
    2. Women with known or clinically detected pregnancy,
    3. Patients with known allergies to perampanel or to any of the excipients mentioned in the SmPC
    4. Patients with postanoxic status
    5. Patients in coma (Glasgow<8).
    6. Patients with motor events for which a nonepileptic psychogenic origin is suspected
    7. Patients whose status epilepticus is linked to a pathological condition, such as trauma, who needed immediate surgery
    8. Known current treatment by perampanel
    9. Known galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption syndrome (rare hereditary diseases)
    10. Known participation in another trial with medication and/or previously included in PEPSI study
    1. Insuffisance hépatique grave (Factor V <50 %) ou rénale grave (taux de filtration glomérulaire 15-29 ml/min/1,72 m2) connue
    2. Femmes ayant une grossesse connue ou cliniquement détectée.
    3. Patients ayant des allergies connues au pérampanel ou à l’un des excipients mentionnés dans le RCP
    4. Patients présentant un état de mal post-anoxique
    5. Patients dans le coma (Glasgow <8).
    6. Patients présentant des événements moteurs pour lesquels une origine psychogène non-epileptique est suspectée.
    7. Les patients dont l'état de mal épileptique est lié à un état pathologique, tel qu'un traumatisme, nécessitant une intervention chirurgicale immédiate.
    8. Patients actuellement traités par pérampanel
    9. Intolérance au galactose, déficit en Lapp lactase ou syndrome de malabsorption du glucose-galactose (maladies héréditaires rares) connus
    10. Patients participant à un autre essai avec des médicaments et / ou ayant déjà été inclus dans l'étude PEPSI
    E.5 End points
    E.5.1Primary end point(s)
    No Seizure or seizure cessation within the 2 and 3 hours after the perampanel or placebo administration (H2 to H3) :
    - defined clinically by the absence or cessation between H2 and H3 of any epileptic movements (clonic, tonic or myoclonic)
    - once the seizures stop, no seizure recurrence should be observed during at least 60 minutes.
    - without the use of an additional second line intravenous antiepileptic drug between H0 and H3.
    L’arrêt des crises dans les 2 et 3 heures après l’administration du perampanel ou du placébo (entre H2 à H3) :
    - défini cliniquement par l’absence ou l’arrêt entre H2 et H3 de tout mouvement épileptique (clonique, tonique ou myoclonique),
    - une fois les crises arrêtées, il ne doit pas y avoir de récurrence durant au moins 60 minutes
    - sans utilisation d’une seconde ligne de traitement antiépileptique intraveineux entre H0 et H3
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary end point will rely on clinical assessment (systematic neurological observation of 2 minutes duration) at least every 15 minutes from H2 to H4 (i.e. minimum 9 observations)
    Le critère principal s’appuiera sur l'évaluation clinique (observation neurologique systématique d’une durée de 2 minutes) au moins toutes les 15 minutes de H2 à H4 (c'est-à-dire au minimum 9 observations).
    E.5.2Secondary end point(s)
    • Seizure cessation from H2 to H6, H2 to H12 and H2 to H24
    • Time to seizure cessation, within the 24h after the administration of perampanel or placebo,
    • Time to seizure cessation, within the 24h after the administration of perampanel or placebo, without the use of an additional second line intravenous antiepileptic drug
    •The need for additional second line antiepileptic drugs to control the status epilepticus within the 24h
    • The need for endotracheal intubation for general anesthesia within the 24h
    • The need for endotracheal intubation for disorder of consciousness within the 24h
    • Glascow Coma Scale (GCS; see Annex) score<8 at H3, H6, H12 and H24; measured by physician
    • Duration of overall hospitalization (ICU/step down/standard hospitalisation/ after care and rehabilitation) and duration of hospitalization in ICU/step down unit, both censored 14 days after randomization
    • Seizure recurrence, defined as focal motor seizure lasting less than 10 minutes, between H3 and H24 and time of recurrence. Recurrence is defined by reappearance of epileptic mouvements after a period of at least one hour of seizure cessation
    • Status epilepticus recurrence, defined as focal motor seizure lasting more than 10 minutes or repeated focal motor seizures (≥4 seizures in 10 min), between H3 and H24 and time of recurrence
    • Secondary generalized seizures, defined as convulsive tonic or clonic bilateral seizure lasting less than 5 minutes, between H0 and H24.
    • Convulsive generalized status epilepticus, defined as convulsive tonic or clonic bilateral seizure lasting more than 5 minutes or 2 or more seizures in 5 minutes without recovery of consciousness between the seizures, between H0 and H24.
    • Vital status, Glasgow Outcome Scale score and return to previous neurological state (i.e. before focal status epilepticus) at the end of the study period (end of hospitalization or after 14 days if still hospitalized); measured by physician
    • Occurence and severity of adverse events (see specific paragraph for definition)
    • Seizure cessation within 1 h after administration of the conventional second line intravenous antiepileptic drug.
    • The primary endpoint will also be investigated in subgroups, according to etiology (acute symptomatic versus remote symptomatic versus cryptogenic causes; identification of a brain lesion versus not), duration of SE and type of conventional antiepileptic drug administrated
    - Arrêt des crises de H2 à H6, de H2 à H12 et de H2 à H24
    - Temps d’arrêt des crises, dans les 24 heures suivant l'administration du pérampanel ou du placebo.
    - temps d’arrêt des crises, dans les 24 heures suivant
    l'administration du pérampanel ou du placebo, sans recours à une seconde ligne de traitement antiépileptique supplémentaire.
    - Le besoin d’une seconde ligne de traitement antiépileptique supplémentaire pour contrôler l’état de mal épileptique au cours des 24 heures.
    - Le besoin d'intubation endotrachéale pour anesthésie générale dans les 24h.
    - Le besoin d'intubation endotrachéale pour un trouble de la vigilance dans les 24h.
    - L’échelle de Glascow <8 à H3, H6, H12 et H24 mesurée par un médecin ou une infirmière.
    - Durée de l'hospitalisation globale (USI / unité de soins continus / hospitalisation standard soins de suite et rééducation) et durée de l'hospitalisation en USI / unité de soins continus, limitée aux 14 jours après la randomisation.
    - Récidive de crise définie comme une crise motrice focale de moins de 10 minutes, entre H3 et H24 et le temps de la récidive. La récidive est définie par la réapparition de mouvements épileptiques après une période d'au moins une heure d'arrêt des crises.
    - Récidive d'état de mal épileptique, définie comme une crise motrice focale de plus de 10 minutes ou une crise motrice focale répétée (≥ 4 crises en 10 min), entre H3 et H24 et le temps de récidive.
    - Crises secondaires généralisées, définies comme une crise convulsive tonique ou clonique bilatérale durant moins de 5 minutes, entre H0 et H24.
    - État épileptique généralisé convulsif, défini comme une crise tonique ou clonique bilatérale durant plus de 5 minutes ou 2 crises convulsives ou plus en 5 minutes sans reprise de conscience entre les crises, entre H0 et H24.
    - Statut vital, l’échelle de devenir de Glasgow et retour à l'état neurologique antérieur (c'est-à-dire avant l'état de mal épileptique) à la fin de la période de l'étude (fin de l'hospitalisation ou après 14 jours si toujours hospitalisé); mesuré par un médecin.
    - Survenue et sévérité des événements indésirables.
    - Arrêt des crises dans l’heure après administration de la seconde ligne conventionnelle de traitement antiépileptique intraveineux
    - Le critère principal sera également étudié en sous-groupes, selon l'étiologie (cause symptomatique aigue versus cause symptomatique sur une lésion ancienne versus cryptogéniques ; identification d'une lésion cérébrale versus non), la durée de l’état de mal épileptique et le type de médicament antiépileptique conventionnel administré.
    E.5.2.1Timepoint(s) of evaluation of this end point
    H2, H6, H12 and H24
    H2, H6, H12 et H24
    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 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 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 concerned37
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 332
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 332
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state332
    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)
    A la fin de la participation du patient, lors de sa sortie de l’hôpital, un médicament antiépileptique lui sera prescrit. Ce dernier sera choisi par le médecin qui l'a pris en charge. Il ne s'agira pas nécessairement de celui évalué initialement dans cette étude.
    A la fin de la participation du patient, lors de sa sortie de l’hôpital, un médicament antiépileptique lui sera prescrit. Ce dernier sera choisi par le médecin qui l'a pris en charge. Il ne s'agira pas nécessairement de celui évalué initialement dans cette étude.
    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 Decision2019-10-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-07-15
    P. End of Trial
    P.End of Trial StatusOngoing
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