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    Summary
    EudraCT Number:2018-000991-13
    Sponsor's Protocol Code Number:STH19610
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2019-11-08
    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 ConcernedUK - MHRA
    A.2EudraCT number2018-000991-13
    A.3Full title of the trial
    The MAGIC trial (Melatonin for Anxiety prior to General anaesthesia In Children): A Multicentre, Parallel Randomised Controlled Trial of Melatonin Versus Midazolam in the Premedication of Anxious Children Attending for Elective Dental, Ophthalmologic or ENT Surgery Under General Anaesthesia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The MAGIC trial (Melatonin for Anxiety prior to General anaesthesia In Children)
    A.3.2Name or abbreviated title of the trial where available
    Melatonin for Anxiety prior to General anaesthesia In Children (MAGIC)
    A.4.1Sponsor's protocol code numberSTH19610
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSheffield Teaching Hospitals NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    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 supportNIHR
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Trials Research Unit, ScHARR, University of Sheffield
    B.5.2Functional name of contact pointStudy Manager
    B.5.3 Address:
    B.5.3.1Street Address30 Regent Street
    B.5.3.2Town/ citySheffield
    B.5.3.3Post codeS1 4DA
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01142220772
    B.5.6E-maila.l.thomason@sheffield.ac.uk
    D. IMP Identification
    D.IMP: 1
    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 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 nameMidazolam
    D.3.4Pharmaceutical form Oral liquid
    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.3.9.3Other descriptive nameMidazolam
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/l milligram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 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 nameMelatonin
    D.3.4Pharmaceutical form Oral liquid
    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.3.9.3Other descriptive nameMelatonin
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Anxiety pre-general anaesthesia
    E.1.1.1Medical condition in easily understood language
    Anxiety pre-general anaesthesia
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Behaviours [F01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10002869
    E.1.2Term Anxiety symptoms
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10054711
    E.1.2Term Postoperative pain
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10049989
    E.1.2Term Agitation postoperative
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10002855
    E.1.2Term Anxiety
    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 aim of this study is to assess whether melatonin is as good as midazolam, in reducing pre-operative anxiety in children prior to general anaesthesia for Ear, Nose and Throat (ENT), ophthalmologic and dental surgery. It will be evaluated using the m-YPAS score over various timepoints prior to surgery.
    E.2.2Secondary objectives of the trial
    Feasibility objectives:
    To undertake an internal pilot trial to determine the feasibility of a full-scale trial, in terms of:
    • Recruitment
    • Retention (adverse events reporting and PHBQ follow-up)
    • Allocation concealment & blinding

    Efficacy objectives:
    To evaluate if melatonin, in relation to midazolam is:
    • Superior in dealing with secondary efficacy outcomes (anaesthetic turnaround time, recovery time)
    • Non inferior in dealing with secondary efficacy outcomes (anaesthetic failure rate)

    Safety objectives:
    • To evaluate if melatonin, in relation to midazolam is superior in dealing with secondary safety outcomes (PAED, VSR, FPS-R, analgesia requirements, post-hospitalisation behaviour questionnaire (PHBQ), nausea & vomiting, respiratory suppression, orientation and cognitive/psychomotor function)
    • To describe Serious Adverse Events data (summarised both at patient level and event level) and report listings between the different arms.

    Qualitative objectives:
    An integrated qualit
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Title: Personalised text message versus standard text message prompts for increasing trial participant response to telephone follow-up in the Melatonin for Anxiety prior to General anaesthesia In Children (MAGIC) trial: embedded randomised controlled trial

    This sub-study is not relevant to this application since it does not test the drug intervention.
    E.3Principal inclusion criteria
    1. Children aged 5-14 years undergoing elective dental, ophthalmological or ENT surgery under general anaesthesia.
    2. Pragmatically assessed by healthcare professionals as requiring premedication as per local standard care for high/expected high levels of preoperative distress prior to elective dental/ENT/ophthalmological surgery under general anaesthetic, including known negative experiences, failed anaesthesia, parents displaying high levels of distress, additional/special needs or judged as unable to tolerate general anaesthetic without premedication
    3. ASA grades I & II
    4. Parent or person with parental responsibility able to give written, informed consent and child willing to assent
    E.4Principal exclusion criteria
    1. Not undergoing elective, day-case dental, ophthalmological or ENT surgery under general anaesthesia
    2. Not displaying level of anxiety that would usually warrant premedication under the standard NHS care pathway
    3. Reason for premedication other than anxiety
    4. Current prescription of melatonin, midazolam or other non-permitted drug (please see section 7.11.2)
    5. Obstructive sleep apnoea
    6. ASA grades III, IV & V
    7. Severe learning disability rendering child unable to communicate even with specialised support
    E.5 End points
    E.5.1Primary end point(s)
    Preoperative distress by modified Yale Preoperative Anxiety Scale (mYPAS).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline and then:

    1. Start of transfer to TAU
    2. Entry to TAU
    3. Administration of anaesthesia
    E.5.2Secondary end point(s)
    Efficacy endpoints:
    • Emergence agitation (PAED index)
    • Postoperative sedation (Vancouver Sedation Recovery Scale, recovery time)
    • Postoperative pain (Revised Faces Pain Scale, FPS-R; postoperative analgesia requirements, intraoperative local anaesthetic amount)
    • Failed anaesthesia
    • Orientation and cognitive/psychomotor function (Cooperation score, modified post-box test)

    Parent-reported:
    • STAI (State-Trait Anxiety Inventory) – parental anxiety; self-reported
    • Post-discharge behaviour, eating, anxiety, aggression, apathy and sleep disturbance (Post-Hospital Behaviour Questionnaire; PHBQ)

    Harms/Adverse Events

    Qualitative endpoints:
    • Semi-structured interviews will be conducted with children, parents, those recruiting to the trial and clinical team members

    Economic endpoints:
    • Cost-effectiveness analysis; resource use, health-related quality of life; CHU9D questionnaire, costs and incremental cost-effectiveness (cost per QALY and cost per successful procedure).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy endpoints:
    - PAED, VSR and FPS-R indices to be recorded every 10 minutes in the post-anaesthesia care unit (PACU) until stage 2 anaesthetic recovery is completed.
    - Cooperation score, modified post-box test at baseline and post-surgery
    - STAI at baseline only
    - PHBQ at 14 days phone call only
    - AEs collected at transfer to, peri- & post-surgery and at 14 days phone call

    Qualitative endpoints:
    - interviews to be held up to a few weeks post-surgery

    Economic endpoints:
    - CHU9D to be completed at baseline and 14 days phone call
    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 No
    E.8.1.4Double blind Yes
    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) 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 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 concerned20
    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 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
    LVLS -The study will end after the last follow-up visit of the last study participant. Sites will be closed once data cleaning is completed and the regulatory authority and ethics committee have been informed.
    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 months6
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days14
    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: 624
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 437
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 187
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 5-14) giving assent only. Parents/legal guardian will give full consent
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state624
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 624
    F.4.2.2In the whole clinical trial 624
    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)
    The IMP is taken as a single-dose, so after the trial is finished there will be no requirement for patients to receive any IMP.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Clinical Research Network Yorkshire & Humber
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-12-20
    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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