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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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:2015-000955-25
    Sponsor's Protocol Code Number:PSS2015/EFFET-LEHEUP/SKJ
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2015-06-19
    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 number2015-000955-25
    A.3Full title of the trial
    Evaluation of the efficiency of folinic acid in children with autism spectrum disorders: a pilot study "EFFET"
    Évaluation de l’efficacité de l’acide folinique chez les enfants présentant des troubles du spectre autistique : étude pilote «EFFET»
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the efficiency of B9 vitamin on the reduction of autistic spectrum symptoms:a pilot study "EFFET"
    Evaluation de l'efficacité de la vitamine B9 sur la réduction des symptomes du spectre autistique : étude pilote «EFFET»
    A.3.2Name or abbreviated title of the trial where available
    EFFET
    EFFET
    A.4.1Sponsor's protocol code numberPSS2015/EFFET-LEHEUP/SKJ
    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 SponsorCentre Hospitalier Régional Universitaire de Nancy
    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 supportCHRU de Nancy
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDirection de la Recherche et de l'Innovation
    B.5.2Functional name of contact pointSecrétariat
    B.5.3 Address:
    B.5.3.1Street AddressHôpitaux de Brabois-Rue du Morvan
    B.5.3.2Town/ cityVANDOEUVRE LES NANCY
    B.5.3.3Post code54511
    B.5.3.4CountryFrance
    B.5.4Telephone number0033383155285
    B.5.5Fax number0033383157451
    B.5.6E-mailrechclin-innov@chu-nancy.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 FOLINORAL 5mg
    D.2.1.1.2Name of the Marketing Authorisation holderTHERABEL LUCIEN PHARMA
    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.3.4Pharmaceutical form Capsule
    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 INNfolinc acid
    D.3.9.1CAS number 6035-45-6
    D.3.9.2Current sponsor codeacide folinque
    D.3.9.3Other descriptive nameCALCIUM FOLINATE PENTAHYDRATE
    D.3.9.4EV Substance CodeSUB76309
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 placeboCapsule
    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
    Autism spectrum disorders
    Troubles du spectre autistique 
    E.1.1.1Medical condition in easily understood language
    Autism
    Autisme
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10063844
    E.1.2Term Autism spectrum disorder
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of this study is to evaluate the efficiencyof folinic acid, as folinate calicum (FOLINORAL®) 5 mg two times a day during 12 weeks, on the reduction of autism disorder especially on the communication and social interactions.
    L’objectif principal de cette étude est d’évaluer l’efficacité de l’acide folinique, sous forme de folinate de calcium (FOLINORAL®) 5 mg 2 fois par jour pendant 12 semaines, sur la réduction des troubles autistiques en particulier sur la communication et les interactions sociales.
    E.2.2Secondary objectives of the trial
    1)Evaluate the efficiencyof folinic acid on autistic symptoms reducing perceived by parents.
    2)Assess the consistency of the anti-receptor antibody levels folate FRα in autistic children 12 weeks after starting treatment.
    3)Studying the relationship between the presence of antibodies anti-folate receptor FRα before treatment and the response to folic acid treatment 12 weeks after.
    4)Safety evaluation of folinic acid in the 12 weeks of treatment and at the end of this research.
    1)Évaluer l’efficacité de l’acide folinique sur la réduction des symptômes autistiques perçus par les parents.
    2)Évaluer la constance du taux des anticorps anti-récepteurs aux folates FRα chez les enfants autistes 12 semaines après le démarrage du traitement.
    3)Étudier le lien entre la présence d’anticorps anti-récepteurs aux folates FRα au démarrage du traitement et la réponse au traitement par acide folique 12 semaines après son initiation.
    4)Évaluation de la tolérance de l’acide folinique au cours des 12 semaines de traitement et à l’issu de cette recherche.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1)Children with autism spectrum disorders defined by : Autism Diagnostic Observation Schedule (ADOS), Autism Diagnostic Interview (ADI), Childhood Autism Rating Scale (CARS) or diagnosed by a physician (pediatrician, child psychiatrist)
    2)Children aged 3 to 10 years
    3)Weight> 10 kg
    4)Language impairment (based on the medical assessment)
    5)Ability to maintain other therapies started before the study
    6)No changes of therapeutic treatments within the 8 weeks before the start of the study
    1)Enfants souffrant de troubles du spectre autistique définis par : Autism Diagnostic Observation Schedule (ADOS), Autism Diagnostic Interview (ADI), Childhood Autism Rating Scale (CARS) ou diagnostiquée par un médecin spécialisé (pédiatre, pédopsychiatre)
    2)Enfants âgés de 3 ans à 10 ans
    3)Poids >10 kg
    4)Altération du langage (basée sur l’évaluation médicale)
    5)Possibilité de maintenir les autres thérapies débutées avant l’étude
    6)Pas de modifications de prise en charge thérapeutiques dans les 8 semaines précédant le début de l’étude
    E.4Principal exclusion criteria
    1)Treatment may impair folate metabolism (methotrexate, anticonvuslivants : phenobarbital sodium valproate, phenytoin, primidone, carbamazepine, valproic acid, divalproex, antibiotics : tetracycline, trimethoprim, pyrimethamine, inhibitors of proton pump inhibitors of histamine-2)
    2)Antipsychotic treatment (including treatment with Risperidone)
    3)Vitamin or mineral supplementation exceeding guidelines
    4)Children with severe irritability (Aberrant Behavior Checklist> 17)
    5)Gastroesophageal reflux disease
    6)Any known renal or liver disease
    7)Child born premature (<37SA)
    8)Known intolerance to lactose
    9)Hypersensitivity / allergic reaction to calcium folinate
    10)The sibling children with autism spectrum disorders
    1)Traitement pouvant altérer le métabolisme des folates (methotrexate, anticonvuslivants : valproate de sodium phénobarbital, phénytoine, primidone, carbamazépine, acide valproïque, divalproex , antibiotiques : tétracycline, triméthoprime, pyriméthamine, inhibiteurs de la pompe à protons, inhibiteurs de l’histamine-2)
    2)Traitement antipsychotique (dont traitement par Rispéridone)
    3)Supplémentation vitaminique ou minérale excédant les recommandations
    4)Enfant présentant une irritabilité sévère (Aberrant Behavior Checklist >17)
    5)Reflux gastro-oesophagien
    6)Toute pathologie rénale ou hépatique connue
    7)Enfant né prématuré (<37SA)
    8) Intolérance connue au lactose
    9)Hypersensibilité/ allergie connue au folinate de calcium
    10)Enfants, avec troubles du spectre autistique, de la même fratrie
    E.5 End points
    E.5.1Primary end point(s)
    Difference of the score obtained by the ADOS scale, for "communication" and "social interaction" items, between baseline visit (T0) and 12 weeks of treatment visit (S12) in the 2 groups (placebo and folinic acid).
    Différence du score obtenu par l’échelle ADOS pour les parties « communication » et « interactions sociales » entre l’inclusion (T0) et après 12 semaines de traitement (S12) dans les 2 groupes (acide folinique et placebo).
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    12 semaines
    E.5.2Secondary end point(s)
    1)Difference of hetero-assessment SRS score (for parents) before treatment (T0) and after 12 weeks of treatment in folinic acid and placebo groups
    2)Determination of anti-receptor antibody to folate at baseline and at the end of 12 weeks of treatment in the 2 groups.
    3)Response to treatment 12 weeks after initiation
    4)Reports of potential side effects at S3 and S6 by phone calls, at S12 durind the visit and at S24 by phone call
    1)Différence du score d’hétéro-évaluation SRS (chez les parents) avant (T0) et après 12 semaines de traitement dans les groupes acide folinique et placebo
    2)Dosage des anticorps anti-récepteur aux folates à l’inclusion et à l’issu des 12 semaines de traitement dans les 2 groupes.
    3)Réponse au traitement 12 semaines après son initiation
    4)Recueil des effets secondaires potentiels au cours des appels téléphoniques à S3 S6, de la visite à S12 et du questionnaire téléphonique à S24.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1)12 weeks
    2)12 weeks
    3)12 weeks
    4)At weeks : 3, 6, 12 and 24
    1)12 semaines
    2)12 semaines
    3)12 semaines
    4)Aux semaines: 3, 6 , 12 et 24
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.1.4Double blind No
    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 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
    Child's parents will be called by phone at week 12 after cessation of treatment, which corresponds to 24 weeks after the start of the study.
    Un contact téléphonique aura lieu, avec les parents de l'enfant, à 12 semaines après l'arrêt du traitement chez l'enfant ce qui correspond à 24 semaines après le début de l’étude.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months16
    E.8.9.1In the Member State concerned days
    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: 40
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 40
    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
    Children aged 3 to 10 years
    Enfants agés de 3 à 10 ans
    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.4.2.2In the whole clinical trial 40
    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
    A l'issue de cette recherche, les enfants continueront leur suivi habituel dans le cadre de la prise en charge de leur pathologie.
    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 Decision2015-05-21
    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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