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    Summary
    EudraCT Number:2022-001005-43
    Sponsor's Protocol Code Number:STP225
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2022-03-11
    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 number2022-001005-43
    A.3Full title of the trial
    Etude de l’intérêt de l’association du stiripentol (Diacomit®) et de la carbamazépine dans le traitement des patients atteints d’épilepsies focales pharmacorésistantes.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Etude de l’intérêt de l’association du stiripentol (Diacomit®) et de la carbamazépine dans le traitement des patients atteints d’épilepsies focales pharmacorésistantes.
    A.3.2Name or abbreviated title of the trial where available
    CARBASTIR
    A.4.1Sponsor's protocol code numberSTP225
    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 SponsorBiocodex
    B.1.3.4CountryFrance
    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 supportBIOCODEX
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBIOCODEX
    B.5.2Functional name of contact pointregulatory Compliance
    B.5.3 Address:
    B.5.3.1Street Address7 avenue GALLIENI
    B.5.3.2Town/ cityGENTILLY
    B.5.3.3Post code94250
    B.5.3.4CountryFrance
    B.5.4Telephone number+33141243080
    B.5.5Fax number+33141243004
    B.5.6E-mailn.hauguel@biocodex.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 DIACOMIT 250 mg
    D.2.1.1.2Name of the Marketing Authorisation holderBIOCODEX
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameDIACOMIT
    D.3.4Pharmaceutical form Powder for oral suspension in sachet
    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 INNStiripentol
    D.3.9.1CAS number 49763-96-4
    D.3.9.4EV Substance CodeSUB10654MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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.IMP: 2
    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 carbamazepine
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 namecarbamazepine
    D.3.4Pharmaceutical form
    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 INNCARBAMAZEPINE
    D.3.9.1CAS number 298-46-4
    D.3.9.4EV Substance CodeSUB06113MIG
    D.3.10 Strength
    D.3.10.1Concentration unit millilitre(s)/gram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number200 to 400
    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.IMP: 3
    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 DIACOMIT 250 mg
    D.2.1.1.2Name of the Marketing Authorisation holderBIOCODEX
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameDIACOMIT
    D.3.4Pharmaceutical form Capsule, hard
    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 INNStiripentol
    D.3.9.1CAS number 49763-96-4
    D.3.9.4EV Substance CodeSUB10654MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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.IMP: 4
    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 DIACOMIT 500 mg
    D.2.1.1.2Name of the Marketing Authorisation holderBIOCODEX
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameDIACOMIT
    D.3.4Pharmaceutical form Capsule, hard
    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 INNStiripentol
    D.3.9.1CAS number 49763-96-4
    D.3.9.4EV Substance CodeSUB10654MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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.IMP: 5
    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 DIACOMIT 500 mg
    D.2.1.1.2Name of the Marketing Authorisation holderBIOCODEX
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameDIACOMIT
    D.3.4Pharmaceutical form Powder for oral suspension in sachet
    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 INNStiripentol
    D.3.9.1CAS number 49763-96-4
    D.3.9.4EV Substance CodeSUB10654MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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
    L’association carbamazépine/stiripentol est utilisée dans la pratique quotidienne à l’hôpital Necker chez les enfants atteints d’épilepsies focales. Il est donc pertinent d’étudier l’impact de cette association.
    E.1.1.1Medical condition in easily understood language
    L’association carbamazépine/stiripentol est utilisée dans la pratique quotidienne à l’hôpital Necker chez les enfants atteints d’épilepsies focales.
    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
    Etudier le profil et l’évolution des patients atteints d’épilepsies focales pharmacorésistantes traités par l’association carbamazépine/stiripentol et suivis au centre de référence des épilepsies rares de l’enfant de l’hôpital Necker ainsi que les modalités d’utilisation de l’association.
    E.2.2Secondary objectives of the trial
    Etudier chez les patients atteints d’épilepsies focales pharmacorésistantes ayant reçu du stiripentol en association à la carbamazépine :
    - Le taux de rétention de l’association,
    - La réponse à l’association,
    - La tolérance de l’association,
    Etudier chez les patients recevant toujours le stiripentol en association à la carbamazépine :
    - La pharmacocinétique de la carbamazépine, de ses métabolites et du stiripentol.

    Etudier l’influence des polymorphismes génétiques des enzymes et transporteurs impliqués dans la pharmacocinétique du stiripentol, de la carbamazépine et de ses métabolites afin de mieux comprendre les mécanismes d’action de cette association si les conditions d’analyses le permettent.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Parmi les patients dont les dossiers médicaux sont inclus dans la partie rétrospective de la recherche, ceux qui présentent les critères suivants pourront participer à la partie prospective de la recherche :
    1. Actuellement traités par le stiripentol en association à la carbamazépine depuis au moins 15 jours et toujours suivis dans le centre,
    2. Ayant pris connaissance, ou dont les parents ont pris connaissance, de la note d’information et signé le formulaire de consentement. Pour les enfants, si leur niveau de compréhension le permet, leur assentiment sera également recherché,
    3. Maîtrisant suffisamment, ou dont les parents ou tuteurs légaux maîtrisent suffisamment, la langue française pour lire, comprendre et remplir les documents de la recherche,
    4. Affilié(e)s ou bénéficiaires d'un régime de sécurité sociale.
    E.4Principal exclusion criteria
    Les patients présentant les critères suivants ne pourront pas participer à la partie prospective de la recherche :
    1. Participant simultanément à un autre essai clinique interventionnel ou en période d'exclusion suivant un essai précédent,
    2. Dont l’état de santé ne lui permet pas de donner son consentement,
    3. Sous tutelle ou curatelle,
    4. Sous sauvegarde de justice ou personne privée de liberté,
    E.5 End points
    E.5.1Primary end point(s)
    Description du traitement par carbamazépine et stiripentol à chaque visite de suivi :
    - Ajustement du traitement par la carbamazépine
    - Ajustement du traitement par stiripentol
    - Ajustement des autres traitements concomitants
    Description de l’évolution de la pathologie au cours du suivi :
    - A la visite d’initiation de stiripentol et à chaque visite de suivi : description du nombre moyen de crises mensuelles depuis la dernière visite (total et par type de crise), de la nature des crises rapportées et de la durée moyenne de ces crises pour les patients traités par l’association.
    - A la visite d’initiation de stiripentol et pour chaque visite de suivi : proportion de patients ayant présenté des états de mal.
    - Proportion de patient ayant présenté des crises en salves et évolution des patients (patients avec crises en salves à l’initiation de l’association puis sans au cours de suivi et inversement).
    - Survenue des pathologies associées et rapportées au cours du suivi des patients.
    - Proportion de patients ayant nécessité une consultation aux urgences et/ou hospitalisés au cours de la période précédant la visite.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Description du traitement par carbamazépine et stiripentol à chaque visite de suivi :
    Description de l’évolution de la pathologie au cours du suivi :
    - A la visite d’initiation de stiripentol et à chaque visite de suivi
    - A la visite d’initiation de stiripentol et pour chaque visite de suivi.
    - Proportion de patient ayant présenté des crises en salves et évolution des patients.
    - Survenue des pathologies associées et rapportées au cours du suivi des patients.
    - Proportion de patients ayant nécessité une consultation aux urgences et/ou hospitalisés au cours de la période précédant la visite.
    E.5.2Secondary end point(s)
    Dosages plasmatiques de la carbamazépine, de ses métabolites et du stiripentol.
    A titre exploratoire, l’effet des polymorphismes génétiques des cytochromes et transporteurs impliqués dans la pharmacocinétique du stiripentol, de la carbamazépine et de ses métabolites seront étudiés si les conditions d’analyses le permettent.
    E.5.2.1Timepoint(s) of evaluation of this end point
    • t1 : juste avant la prise du traitement,
    • t2 : 30 minutes à 1 heure après la prise du traitement,
    • t3 : 2 à 4 heures après la prise du traitement,
    • t4 : 5 à 8 heures après la prise du traitement,
    -Pour le dosage plasmatique du stiripentol, de la carbamazépine et de ses métabolites (en t1, t2, t3 et t4).
    -Pour étudier les polymorphismes génétiques des enzymes et transporteurs impliqués dans la pharmacocinétique du stiripentol, de la carbamazépine et de ses métabolites (en t1),
    -Pour effectuer un bilan de la fonction hépatique (en t1),
    -Pour effectuer une numération de la formule sanguine (en t1).
    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 No
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    Etude de l’intérêt de l’association du stiripentol (Diacomit®) et de la carbamazépine dans le traitement des patients atteints d’épilepsies focales pharmacorésistantes.
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned 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: 30
    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: 30
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 30
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 30
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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
    children may be included in the study
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    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
    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 Decision2022-04-12
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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