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    Summary
    EudraCT Number:2012-000220-18
    Sponsor's Protocol Code Number:C.2524.0472.01
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-04-17
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2012-000220-18
    A.3Full title of the trial
    Effects of melatonin treatment, light therapy, and sleep improvement on psychosocial, cognitive, and behavioural outcomes in children with Delayed Sleep Phase Syndrome and their parents
    Onderzoek naar de effecten van melatonine, lichttherapie en slaapverbetering op psychosociale, cognitieve en gedragsuitkomsten in kinderen met verlaat slaapfase syndroom en hun ouders
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of melatonin treatment, light therapy, and sleep improvement in children with sleep onset problems
    Onderzoek naar de effecten van melatonine, lichttherapie en slaapverbetering in kinderen met inslaapproblemen
    A.3.2Name or abbreviated title of the trial where available
    Melatonin treatment, light therapy, and sleep improvement in children
    Melatoninebehandeling, lichttherapie en slaapverbetering bij kinderen
    A.4.1Sponsor's protocol code numberC.2524.0472.01
    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 SponsorUniversity of Amsterdam
    B.1.3.4CountryNetherlands
    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 supportUniversity of Amsterdam
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportPharma Nord
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Amsterdam
    B.5.2Functional name of contact pointResearch Institute
    B.5.3 Address:
    B.5.3.1Street AddressNieuwe Prinsengracht 130
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1018 VZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310205251235
    B.5.5Fax number00310205251200
    B.5.6E-mailA.vanMaanen@uva.nl
    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 Yes
    D.2.1.1.1Trade name Bio-Melatonin
    D.2.1.1.2Name of the Marketing Authorisation holderPharma Nord ApS
    D.2.1.2Country which granted the Marketing AuthorisationHungary
    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 Tablet
    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.3.9.1CAS number 73-31-4
    D.3.9.3Other descriptive nameMELATONIN
    D.3.9.4EV Substance CodeSUB14496MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number2.85 to 3.15
    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 Yes
    D.3.11.13.1Other medicinal product typeNutritional supplement in Holland/medicine in Hungary
    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 placeboTablet
    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
    Delayed Sleep Phase Syndrome
    Verlaat slaapfase syndroom
    E.1.1.1Medical condition in easily understood language
    Sleep onset problems
    Inslaapproblemen
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]
    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
    The general aim of the present study is to investigate, in a longitudinal-experimental design, the effects of melatonin treatment and light therapy in children on sleep, health, and various psychosocial, behavioural, and cognitive outcomes.
    Het algemene doel van dit onderzoek is om in een longitudinaal-experimenteel design, de effecten van melatoninebehandeling en lichttherapie op slaap, gezondheid en verschillende psychosociale, gedrags- en cognitieve uitkomstmaten bij kinderen te onderzoeken.
    E.2.2Secondary objectives of the trial
    A second aim is to investigate whether improvements in psychosocial, behavioural and cognitive outcomes can be attributed to improved sleep, or to melatonin or light therapy itself. Third, relationships between children’s sleep, functioning, and parenting will be examined.
    Een tweede doel is om te onderzoeken of verbeteringen in psychosociale, gedrags- en cognitieve uitkomsten toegeschreven kunnen worden aan verbeterde slaap, of aan melatonine of lichttherapie zelf. Een derde doel is om de relaties tussen slaap en functioneren van kinderen en opvoeding te onderzoeken.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - The child is between 7 and 12 years old.
    - The child has DSPS, which is indicated by:
    (a) a complaint of an inability to fall asleep at the desired clock time, an ability to awaken spontaneously at the desired time of awakening, or excessive sleepiness,
    (b) there is a phase delay of the major sleep episode in relation to the desired time for sleep,
    (c) the symptoms are present for at least 1 month,
    (d) when not required to maintain a strict schedule (e.g., vacation time), patients will exhibit all of the following: (1) have a habitual sleep period that is sound and of normal quality and duration, (2) awaken spontaneously, (3) maintain stable entrainment to a 24-hour sleep-wake pattern at a delayed phase,
    (e) sleep-wake logs must demonstrate evidence of a delay in the timing of the habitual sleep period.
    - Dim Light Melatonin Onset (DLMO) later than 20.00 h.
    - Het kind is tussen 7 en 12 jaar oud.
    - Het kind heeft DSPS, wat blijkt uit:
    (a) Een klacht over een onvermogen in slaap te vallen op de gewenste tijd, een onvermogen spontaan te ontwaken op de gewenste tijd, of excessieve slaperigheid
    (b) Er is een verschuiving van de voornaamste slaapepisode in relatie tot de gewenste slaaptijd
    (c) De symptomen zijn minstens 1 maand aanwezig
    (d) Wanneer het niet noodzakelijk is een strikt schema aan te houden (bijv. in vakantietijd), hebben patiënten het volgende: (1) een gebruikelijke slaapperiode van normale kwaliteit en duur, (2) spontaan ontwaken, (3) behoud van een stabiel 24-uurs-slaapwaakpatroon in een verlate fase
    (e) Slaapdagboekjes tonen een verlate timing van de gebruikelijke slaapperiode.
    - Dim Light Melatonin Onset (DLMO) later dan 20.00 uur.
    E.4Principal exclusion criteria
    - pervasive developmental disorder
    - chronic pain
    - known disturbed hepatic or renal function
    - Roter or Dubin-Johnson syndrome
    - epilepsy
    - use of stimulants, neuroleptics, benzodiazepines, clonidine, antidepressants, hypnotics, or β-blockers within 4 weeks before enrolment
    - total IQ <80
    - pervasieve ontwikkelingsstoornis
    - chronische pijn
    - verstoorde lever- of nierfunctie
    - Roter of Dubin-Johnson syndroom
    - Epilepsie
    - Gebruik van opwekkingsmiddelen, neuroleptica, benzodiazepines, clonidine, antidepressiva, hypnotica of β-blokkers binnen 4 weken voor de inclusie
    - Totaal IQ<80
    E.5 End points
    E.5.1Primary end point(s)
    Significant improvements in sleep (shorter sleep onset latency, earlier sleep onset time, longer total sleep time) during treatment compared to baseline.
    Significante verbeteringen in slaap (kortere slaaplatentie, eerdere inslaaptijd, langere slaapduur) tijdens de behandeling in vergelijking met baseline.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Directly after the last participant finished his/her treatment.
    Direct na het einde van de laatste behandeling van de laatste patiënt.
    E.5.2Secondary end point(s)
    Significant improvements on variables measured with the questionnaires (attention problems, child behaviour, inhibitory control, mood, health, functioning at school, parental sleep, parenting stress, parenting) and cognitive tests during and directly after treatment compared to baseline, and significant earlier Dim Light Melatonin Onset directly after treatment compared to baseline.
    Significante verbeteringen op variabelen gemeten met de vragenlijsten (aandachtsproblemen, gedrag van het kind, inhibitiecontrole, stemming, gezondheid, functioneren op school, slaap van de ouders, opvoedingsstress, opvoeding) en cognitieve tests gedurende en direct na de behandeling vergeleken met baseline, en significant vervroegde Dim Light Melatonin Onset direct na behandeling vergeleken met baseline.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Directly after the last participant finished his/her treatment.
    Direct na het einde van de laatste behandeling van de laatste patiënt.
    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 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
    Secundary and indirect effects
    Secundaire en indirecte effecten
    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) 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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    lichttherapie
    light therapy
    E.8.2.4Number of treatment arms in the trial3
    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.8.4.1Number of sites anticipated in Member State concerned1
    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
    LBLP
    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 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: 192
    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: 160
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 32
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state192
    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)
    Patients can continue regular treatment after the trial
    Kinderen kunnen reguliere behandeling voortzetten na het onderzoek
    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 Decision2012-04-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-03-25
    P. End of Trial
    P.End of Trial StatusOngoing
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