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    The EU Clinical Trials Register currently displays   44338   clinical trials with a EudraCT protocol, of which   7368   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2016-002107-26
    Sponsor's Protocol Code Number:EP0078
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-07-10
    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 ConcernedFrance - ANSM
    A.2EudraCT number2016-002107-26
    A.3Full title of the trial
    AN OPEN-LABEL ADAPTIVE STUDY FOR THE ASSESSMENT OF SAFETY, TOLERABILITY, PHARMACOKINETICS, AND EFFICACY OF MULTIPLE DOSES OF RADIPRODIL IN SUBJECTS WITH DRUG-RESISTANT INFANTILE SPASMS
    ÉTUDE ADAPTATIVE EN OUVERT DESTINÉE À ÉVALUER LA TOLÉRANCE, LA SÉCURITÉ D’EMPLOI, LA PHARMACOCINÉTIQUE ET L’EFFICACITÉ DE DOSES MULTIPLES DE RADIPRODIL CHEZ DES PATIENTS PRÉSENTANT DES SPASMES INFANTILES RÉSISTANTS AU TRAITEMENT
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase 2 study of Radiprodil in subjects with drug-resistant infantile spasms (IS)
    Etude de phase 2 du Radiprodil chez des patients présentant des spasmes infantiles résistants au traitement
    A.4.1Sponsor's protocol code numberEP0078
    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 SPRL
    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 SPRL
    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 nameRadiprodil
    D.3.2Product code UCB3491
    D.3.4Pharmaceutical form Granules for oral suspension
    D.3.4.1Specific paediatric formulation Yes
    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 INNRadiprodil
    D.3.9.1CAS number 496054-87-6
    D.3.9.2Current sponsor codeUCB3491
    D.3.9.4EV Substance CodeSUB178336
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.04 to 0.21
    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
    Infantile spasms (IS)
    Spasmes infantiles (SI)
    E.1.1.1Medical condition in easily understood language
    Infantile spasms is a rare and severe epilepsy condition in which children experience a specific type of seizure (spasm) along with abnormal brain activity
    Les spasmes infantiles constituent une pathologie épileptique rare qui se caractérise par un type unique de convulsions (spasmes) avec des anomalies sévères de l’activité cérébrale chez l'enfant
    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 PT
    E.1.2Classification code 10021750
    E.1.2Term Infantile spasms
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part A:
    - Evaluate the safety and tolerability of radiprodil in subjects with drug-resistant infantile spasms
    - Evaluate the pharmacokinetics of radiprodil in subjects with drug-resistant infantile spasms
    - Evaluate the efficacy of radiprodil in abolishing clinical spasms in subjects with drug-resistant infantile spasms

    Part B:
    - Evaluate the efficacy of radiprodil in abolishing clinical spasms and achieving the resolution of hypsarrhythmia (or other disordered interictal electroencephalogram (EEG) patterns consistent with the
    diagnosis) in subjects with drug-resistant infantile spasms
    - Evaluate the safety and tolerability of radiprodil in subjects with drug-resistant infantile spasms
    Partie A :
    - Évaluer la tolérance et la sécurité d’emploi du radiprodil chez des patients présentant des spasmes infantiles résistants aux médicaments
    - Évaluer la pharmacocinétique du radiprodil chez des patients présentant des spasmes infantiles résistants aux médicaments
    - Évaluer l’efficacité du radiprodil sur l’abolition des spasmes cliniques chez des patients présentant des spasmes infantiles résistants aux médicaments

    Partie B :
    - Évaluer l’efficacité du radiprodil sur l’abolition des spasmes cliniques et l’obtention de la résolution de l’hypsarythmie (ou d'autres profils EEG interictaux anormaux corroborant le diagnostic) chez des patients présentant des spasmes infantiles résistants aux médicaments
    - Évaluer la tolérance et la sécurité d’emploi du radiprodil chez des patients présentant des spasmes infantiles résistants aux médicaments
    E.2.2Secondary objectives of the trial
    Part A:
    - Evaluate resolution of hypsarrhythmia (or other disordered interictal EEG patterns consistent with the diagnosis) in subjects with drug-resistant infantile spasms
    - Evaluate long-term developmental outcomes after treatment with radiprodil in subjects with drug-resistant infantile spasms

    Part B:
    - Evaluate the pharmacokinetics of radiprodil in subjects with drug-resistant infantile spasms
    - Evaluate long-term development outcomes after treatment with radiprodil in subjects with drug-resistant infantile spasms
    Partie A :
    - Évaluer la résolution de l’hypsarythmie (ou d’autres profils EEG interictaux anormaux corroborant le diagnostic)
    - Évaluer le développement à long terme après un traitement par radiprodil chez des patients présentant des spasmes infantiles résistants aux médicaments

    Partie B :
    - Évaluer la pharmacocinétique (concentration dans les liquides corporels) du radiprodil chez des patients présentant des spasmes infantiles résistants aux médicaments
    - Évaluer le développement à long terme après un traitement par radiprodil chez des patients présentant des spasmes infantiles résistants aux médicaments
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Subject is male or female between 2 and 14 months of age
    - Onset of spasms has occurred within 3 months of study start
    - The diagnosis of infantile spasms (IS)
    - Subject has drug-resistant IS
    - Garçon ou fille âgé(e) de 2 à 14 mois
    - Délai maximum de 3 mois depuis l’apparition des spasmes
    - Diagnostic clinique de spasmes infantiles (SI)
    - Patient présentant des SI résistants aux médicaments
    E.4Principal exclusion criteria
    - Subject has hematocrit greater than 60
    - Subject has any medical condition that, in the opinion of the Investigator, could jeopardize or would
    compromise the subject’s ability to participate in this study
    - Subject has a history or current condition predisposing to respiratory dysfunction
    - Concomitant treatment with felbamate
    - Ketogenic diet
    - Previous treatment for IS other than Standard-of-Care (StoC)
    - Clinically significant lab abnormalities
    - Clinically significant abnormality on ECG that, in the opinion of the Investigator, increases the safety risks of participating in the study
    - Subject has a lethal or potentially lethal condition other than IS, with a significant risk of death before 18 months of age
    - Body weight is below 4 kg
    - Known history of severe anaphylactic reaction secondary to medication intake or serious blood dyscrasias
    - Current treatment with perampanel
    - Hématocrite supérieur à 60
    - Pathologie médicale significative, susceptible, d’après l’investigateur, de mettre en péril le patient ou de compromettre sa capacité à participer à cette étude
    - Pathologie prédisposant à des troubles respiratoires
    - Traitement en cours par felbamate
    - Traitement en cours par régime cétogène
    - Pathologie létale ou potentiellement létale autre que SI avec risque significatif de décès avant l’âge de 18 mois, comme l’hyperglycémie non cétosique
    - Poids corporel inférieur à 4 kg
    - Antécédents connus de réaction anaphylactique sévère secondaire à la prise de médicaments ou de dyscrasies sanguines graves
    - Traitement en cours par pérampanel
    E.5 End points
    E.5.1Primary end point(s)
    Part A:
    - Percentage of subjects with clinical response on day 14 of treatment with the maintenance dose of radiprodil

    Part B:
    - Percentage of subjects with electro-clinical response on day 14 of treatment with the maintenance dose of radiprodil
    Partie A :
    - Pourcentage de patients présentant une réponse clinique le jour 14 du traitement par dose d'entretien de radiprodil

    Partie B :
    - Pourcentage de patients présentant une réponse électro-clinique le jour 14 du traitement par dose d'entretien de radiprodil
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 14, counting from the first day of radiprodil at maintenance dose
    Jour 14, à compter du premier jour de traitement par dose d'entretien de radiprodil
    E.5.2Secondary end point(s)
    Part A:
    - Percentage of subjects with electro-clinical response on day 14 of treatment with the maintenance dose of radiprodil

    Part B:
    - Percentage of subjects with clinical response on day 14 of treatment with the maintenance dose of radiprodil

    Part A and Part B:
    - Time to cessation of spasms
    - Percentage of responders with clinical relapse
    - Time to clinical relapse from the day of spasm cessation
    - Percentage of electro-clinical responders with electro-clinical relapse
    - Time to electro-clinical relapse from the day of spasm cessation
    - Percentage of subjects with extended clinical response
    - Percentage of subjects with extended electro-clinical response
    Partie A :
    - Pourcentage de patients présentant une réponse électro-clinique le jour 14 du traitement par dose d'entretien de radiprodil

    Partie B :
    - Pourcentage de patients présentant une réponse clinique le jour 14 du traitement par dose d'entretien de radiprodil

    Partie A et Partie B :
    - Moment de l'arrêt des spasmes
    - Pourcentage de patients répondeurs avec rechute clinique
    - Durée entre la rechute clinique et le jour de l'arrêt des spasmes
    - Pourcentage de patients répondeurs électro-cliniques avec rechute électro-clinique
    - Durée entre la rechute électro-clinique et le jour de l'arrêt des spasmes
    - Pourcentage de patients présentant une réponse clinique durable
    - Pourcentage de patients présentant une réponse électro-clinique durable
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Day 14, counting from Day 14 of treatment with the maintenance dose of radiprodil
    - During the first 14 days of treatment with radiprodil
    - 12 months, counting from Day 14 of treatment with the maintenance dose of radiprodil
    - From day of spasms cessation up to 42 months of age
    - 28 days, counting from Day 14 (inclusive) of treatment with the maintenance dose of radiprodil
    - Jour 14, à compter du premier jour de traitement par dose d'entretien de radiprodil
    - Pendant les 14 premiers jours de traitement par radiprodil
    - 12 mois, à compter du premier jour de traitement par dose d'entretien de radiprodil
    - Du jour de l'arrêt des spasmes jusqu'à l'âge de 42 mois
    - 28 jours, à compter du jour 14 (inclus) de traitement par dose d'entretien de radiprodil
    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 Yes
    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
    Tolérance
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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
    Belgium
    France
    Germany
    United Kingdom
    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 Subject Last Visit (LSLV)
    Dernière visite du dernier patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years4
    E.8.9.2In all countries concerned by the trial months2
    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: 60
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 60
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    This trial includes infants with a minimal age of 2 months and a maximal age of 14 months. An Institutional Review Board/Independent Ethics Committee approved written Informed Assent form is signed and dated by the parent(s) or legal representative.
    L'étude prévoit d'inclure des enfants âgés de 2 mois minimum à 14 mois maximum. Un formulaire de consentement approuvé par un Comité d'Ethique est signé et daté par le(s) parent(s) ou le représentant legal.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    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)
    None
    Aucun
    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 Decision2017-06-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-05-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-10-02
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