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    Summary
    EudraCT Number:2021-004456-42
    Sponsor's Protocol Code Number:P2021/Anesth/MIDEXMRI
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-04-19
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2021-004456-42
    A.3Full title of the trial
    Prospective, randomized, double-blind, double-dummy, active-controlled, phase 3 clinical trial comparing the safety and efficacy of intranasal dexmedetomidine to oral midazolam as premedication for propofol sedation in pediatric patients undergoing magnetic resonance imaging
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Intranasal dexmedetomidine versus oral midazolam as premedication for propofol sedation in pediatric patients undergoing magnetic resonance imaging
    A.3.2Name or abbreviated title of the trial where available
    MIDEX MRI
    A.4.1Sponsor's protocol code numberP2021/Anesth/MIDEXMRI
    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 SponsorHôpital Universitaire Des Enfants Reine Fabiola
    B.1.3.4CountryBelgium
    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 supportHôpital Universitaire Des Enfants Reine Fabiola
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHôpital Universitaire Des Enfants Reine Fabiola
    B.5.2Functional name of contact pointClinical Research Unit
    B.5.3 Address:
    B.5.3.1Street AddressPlace Van Gehuchten 4
    B.5.3.2Town/ cityBrussels
    B.5.3.3Post code1020
    B.5.3.4CountryBelgium
    B.5.4Telephone number0032 2477.36.54
    B.5.6E-mailCRU.HUDERF@huderf.be
    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 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.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntranasal use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNdexmedetomidine
    D.3.9.1CAS number 145108-58-3
    D.3.9.3Other descriptive nameDEXMEDETOMIDINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB20317
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 RoleComparator
    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 Ozalin®
    D.2.1.1.2Name of the Marketing Authorisation holderPRIMEX PHARMACEUTICALS OY
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 Oral solution
    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 INNMidazolam
    D.3.9.1CAS number 59467-70-8
    D.3.9.4EV Substance CodeSUB08950MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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
    pre-school pediatric population undergoing magnetic resonance imaging
    E.1.1.1Medical condition in easily understood language
    pre-school pediatric population undergoing magnetic resonance imaging
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    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 demonstrate the superiority of intranasal dexmedetomidine compared to oral midazolam as premedication in a propofol boluses sedation based on the occurrence of any undesirable events during the MRI procedure requiring temporary or definitive interruption of the examination.
    E.2.2Secondary objectives of the trial
    •To assess the synergistic effect between dexmedetomidine and propofol
    •To assess the impact of external factors on the primary outcome
    •To assess the impact of dexmedetomidine on the post-sedation period
    •To assess subject acceptability of intranasal premedication by the CHEOPS scale
    •To assess the quality of MRI images
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Children of both genders aged 6 months to 6 years,
    • ASA score I to IV,
    • Requiring standard of care MRI due to subject’s clinical status, regardless of the underlying pathology,
    • Sedation carried out by an anesthesiologist
    • Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
    E.4Principal exclusion criteria
    • Emergency MRI
    • Presence of head trauma
    • Presence of nasal congestion or upper respiratory tract infection on the day of sedation
    • Children with pathologies requiring airway safety
    • Any known allergic or hypersensitivity reaction to dexmedetomidine and benzodiazepine
    • Concomitant use of negative chronotropes, as Digoxine
    • Patient known with chronic respiratory failure or myasthenia
    • Patient known with anatomical abnormality of the airway, lung disease or sleep apnea syndrome
    • Patient with known cardiac rhythm abnormality and known cardio-vascular disease
    • Patient with known hepatic disorder or chronic kidney disease
    • Patient with hypotension or bradycardia on the day of the examination
    • Patient with a BMI > 97th percentile (which corresponds to overweight, including obesity)
    E.5 End points
    E.5.1Primary end point(s)
    • Incidence and type of any undesirable event during the MRI procedure requiring temporary or definitive interruption of the examination (bradycardia, hypotension, desaturation under 95%, unvoluntary movements of subject)
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of MRI procedure
    E.5.2Secondary end point(s)
    • Cumulative dose in mg/kg of propofol administered during the procedure
    • Number and total dose administered in mg of additional bolus of propofol
    • Time to Aldrete’s score > 9/10 and Chung's score > 9/10 (= time to discharge from the hospital)
    • Length of stay in the post-anaesthesia care unit
    • Assessment of the influence of external factors
    • Assessment of premedication’s acceptability by the CHEOPS scale
    • Classification of MRI images into 2 groups: “without” and “with artefact”.
    E.5.2.1Timepoint(s) of evaluation of this end point
    • At the end of MRI procedure for cumulative dose in mg/kg of propofol and number of aditional bolus
    • At the end of subject's hospital stay for Aldrete's score, Chung's score, lenght of stay and premedication’s acceptability
    • Up to 24H post MRI procedure for AE/SAE reporting
    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 Yes
    E.8.1.7.1Other trial design description
    dubble dummy
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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
    Last patient last visit
    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 months0
    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: 250
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 190
    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
    Pediatric population
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state250
    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. Subject Follow-Up will be performed according to local guidelines
    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 Decision2022-06-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-10-03
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