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    Summary
    EudraCT Number:2018-001466-42
    Sponsor's Protocol Code Number:17-HPNCL-02
    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:2018-04-19
    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 number2018-001466-42
    A.3Full title of the trial
    EFFECTIVENESS OF INTRANASAL DEXMEDETOMIDINE FOR SEDATED
    AUDITORY BRAINSTEM RESPONSE TESTING
    EFFICACITE DE LA DEXMEDETOMIDINE PAR VOIE INTRANASALE DANS LA
    SEDATION POUR LA REALISATION DE POTENTIELS EVOQUES AUDITIFS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EFFECTIVENESS OF INTRANASAL DEXMEDETOMIDINE FOR SEDATED
    AUDITORY BRAINSTEM RESPONSE TESTING
    EFFICACITE DE LA DEXMEDETOMIDINE PAR VOIE INTRANASALE DANS LA
    SEDATION POUR LA REALISATION DE POTENTIELS EVOQUES AUDITIFS
    A.3.2Name or abbreviated title of the trial where available
    DEXMEDETOMIDINE - ABR
    DEXMEDETOMIDINE - PEA
    A.4.1Sponsor's protocol code number17-HPNCL-02
    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 SponsorFondation Lenval - Hôpitaux Pédiatriques de Nice CHULENVAL
    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 supportFondation Lenval - Hôpitaux Pédiatriques de Nice CHULENVAL
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Nice
    B.5.2Functional name of contact pointclinical trials information
    B.5.3 Address:
    B.5.3.1Street Address4 avenue Reine Victoria
    B.5.3.2Town/ cityNice
    B.5.3.3Post code06003
    B.5.3.4CountryFrance
    B.5.4Telephone number+330492034760
    B.5.5Fax number+330492034075
    B.5.6E-maildonzeau.d@chu-nice.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 Dexdor
    D.2.1.1.2Name of the Marketing Authorisation holderOrion Corporation
    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 nameDEXDOR
    D.3.4Pharmaceutical form Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntranasal use (Noncurrent)
    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
    Child requiring auditory evaluation in a context of suspicion of deafness, language delay, overall developmental delay, risk factors for hearing loss.
    Enfant nécessitant une évaluation auditive dans un contexte de suspicion de surdité, retard de langage, retard global du développement, facteurs de risque de perte auditive.
    E.1.1.1Medical condition in easily understood language
    Child requiring auditory evaluation, need to be asleep
    Enfant nécessitant une évaluation auditive dans des conditions d'endormissement
    E.1.1.2Therapeutic area Diseases [C] - Ear, nose and throat diseases [C09]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10049507
    E.1.2Term Brain stem auditory evoked response
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Estimate the effectiveness of intranasal dexmedetomidine in the
    realization of the auditory brainstem response at the child with a
    cognitive or behavioral disorder.
    Evaluer l'efficacité de la dexmedetomidine dans la réalisation des
    potentiels évoqués auditif chez l'enfant avec un trouble cognitif ou
    comportemental.
    E.2.2Secondary objectives of the trial
    1) Tolerance study of dexmedetomidine for sedated auditory branstem
    response testing at the child
    2) Evaluation of time to obtain of a correct sedation.
    3) Evaluation of time to get a conscient wake up.
    1) Etude de la tolérance de l'utilisation de la dexmedetomidine dans le
    cadre de la sédation pour la réalisation des potentiels évoqués auditif
    chez l'enfant
    2) Evaluation de la rapidité d'obtention d'une sédation correcte.
    3) Evaluation de la rapidité de reprise de la vigilance
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Child aged 1 to 15 years old
    -ASA 1 or 2 (American Society Anesthesiologists scale patient)
    -Need to evaluate the child audition in a context of suspicion of
    deafness, delay of language, global delay of the development, the risk
    factors of hearing loss
    -Impossibility to realize a hearing test by conventional audiogram or
    behavioral due to a cognitive or behavioral disorder of the child
    -Affiliation to social security scheme
    -Signature of the authorization documents of the 2 parents or the
    representative of the parental authority for the participation of the child
    in the study
    -enfants de 1 à 15 ans
    -ASA 1 ou 2 (classification de l'état de santé du patient de l'American
    Society of Anesthesiologists)
    -nécessité d'évaluer l'audition de l'enfant dans un contexte de suspicion
    de surdité, retard de langage, retard global du développement, facteurs
    de risque de perte auditive (CMV, antécédent de méningite, traitement
    ototoxique, antécédents familials de surdité, syndrome malformatif)
    -impossibilité de réaliser un test auditif par audiogramme conventionnel
    ou comportemental dû à un trouble cognitif ou comportemental de
    l'enfant
    -affiliation à un régime de la sécurité sociale
    -signature des documents d'autorisation des 2 parents ou du
    représentant de l'autorité parentale pour la participation de l'enfant à
    l'étude
    E.4Principal exclusion criteria
    - Heart disease or heart rhythm disorder
    - Pneumopathy or asthmatic crisis in previous 2 weeks in the
    examination
    - Recent used of digoxine or beta-blocker
    - Use of anti-epileptic or psychotropic drugs
    - Medical history of sleep apnea
    - Receptor alpha2 agonist allergy
    - Gastrooesophageal reflux disease
    - Upper airway abnormality
    - Acute cerebrovascular diseases
    - Neurologic disorders ( cranial trauma and after neurosurgical
    operation)
    - Recent CVA
    - Moyamoya disease
    - General anesthesia planned for another procedure
    - Cardiopathie ou pathologie du rythme cardiaque
    - Pneumopathie ou crise d'asthme dans les 2 semaines précédentes à
    l'examen
    - Utilisation récente de digoxine ou beta-bloquants
    - Utilisation de médicaments antiépileptiques ou psychotropes
    - Antécédents d'apnée du sommeil
    - Allergie aux agonistes des récepteurs α-2
    - Reflux gastro-oesophagien
    XML File Identifier: OjPZZRAZwJDsWiLiT2TPg4l7S1c=
    Page 12/22
    - Anomalie des voies aériennes supérieures
    - Pathologies cérébro-vasculaires aigues
    - Troubles neurologiques (traumatisme crânien et après une
    intervention neurochirurgicale)
    - AVC récent
    - Maladie de Moya-Moya
    - Anesthésie générale prévue pour une autre procédure
    E.5 End points
    E.5.1Primary end point(s)
    the rate of children included in the study who could determine the
    auditory threshold. The non-determination of this threshold (or the
    determination by resorting to general anesthesia or sedation of another
    type) regardless of the cause will be considered a failure.
    Le critère d'évaluation principal est la réalisation d'un examen de qualité
    permettant de définir le seuil auditif de l'enfant.
    On déterminera ainsi le taux d'enfants inclus dans l'étude chez qui on a
    pu déterminer le seuil auditif. La non détermination de ce seuil (ou la
    détermination en ayant recours à une anesthésie générale ou une
    sédation d'un autre type) quelle qu'en soit la cause sera considérée
    comme un échec
    E.5.1.1Timepoint(s) of evaluation of this end point
    at the end of the realization of auditory brainstem response
    à la fin de la réalisation du POTENTIELS EVOQUES AUDITIFS
    E.5.2Secondary end point(s)
    The tolerance will be studied by the collection of the following
    undesirable effects:
    - hypotension, bradycardia: deviation of> 20% (systolic pressure for
    blood pressure) from the normal values defined for the age of the
    subject under waking conditions
    - hypertension: deviation of> 20% (systolic pressure for blood pressure)
    from the normal values defined for the age of the subject in waking
    conditions
    - decrease in oxygenation: decrease in oxygen saturation <90%
    These effects will be assessed by cardiorespiratory monitoring during
    the examination.
    A routine home phone call on D1 will collect information about possible
    unexpected side effects.
    2) The speed of obtaining a correct sedation is studied by the delay of
    falling asleep: time in minutes between the administration of the drug
    and the obtaining of a correct sedation (4, 5 or 6 of the score of
    Ramsey).
    3) The speed of recovery of vigilance is studied by the wake up time:
    time between the end of the examination, (defined by the end of the
    recording and the disconnection of the electrodes) and the recovery of
    the vigilance of the child , evaluated by the Aldrete score (Appendix 2). A
    score of 9 or more determines a correct recovery of alertness and the
    possibility of returning home. The child will be reevaluated every 10
    minutes until this score is reached.
    1)La tolérance sera étudiée par le recueil des effets indésirables
    suivants:
    -hypotension, bradycardie : déviation de >20 % (pression systolique
    pour la pression sanguine) des valeurs normales définies pour l'âge du
    sujet en conditions de réveil
    -hypertension : déviation de >20 % (pression systolique pour la pression
    sanguine) des valeurs normales définies pour l'âge du sujet en
    conditions de réveil
    -baisse de l'oxygénation : baisse de la saturation d'oxygène <90%
    Ces effets seront évalués par monitorage cardio-respiratoire au cours de
    l'examen.
    Un appel téléphonique systématique au domicile à J1 permettra de
    collecter des informations sur d'éventuels effets indésirables non
    attendus.
    2) La rapidité d'obtention d'une sédation correcte est étudiée par le délai
    d'endormissement: temps en minutes entre l'administration du
    médicament et l'obtention d'une sédation correcte (4, 5 ou 6 du score de
    Ramsey).
    3) La rapidité de reprise de vigilance est étudiée par le délai de réveil :
    temps entre la fin de l'examen, (définie par la fin de l'enregistrement et
    la déconnexion des électrodes) et la reprise de la vigilance de l'enfant,
    évalué par le score d'Aldrete (annexe 2). Un score de 9 ou plus
    détermine une reprise correcte de la vigilance et la possibilité du retour
    à domicile. L'enfant sera réévalué tous les 10 minutes jusqu'à atteindre
    ce score.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) during examination and by phone one day after
    2) from introduction of the sedation to feel asleep
    3) from the end of examination to wake-up of patient
    1) pendant l'examen et le jour suivant par un appel téléphonique
    2) de l'introduction du sédatif jusqu'à l'endormissement du patient
    3) de la fin de l'examen jusqu'au réveil du patient
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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.8.3 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
    the end of the trial is the last visit of the last subject
    la fin de l'essai correspond à 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 years2
    E.8.9.1In the Member State concerned months6
    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: 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: 20
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 20
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 20
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Infant (12 months - 23 months) and children (2 years - 5 years)
    nourrissons à partir de 1 an et enfants de moins de 6 ans
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    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
    non
    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 Decision2018-06-28
    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 StatusCompleted
    P.Date of the global end of the trial2021-11-16
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