Metabolism and safety of different melatonin doses for healthy children and adolescents

A parallel group, double-blinded randomised multi dose pharmacokinetic and safety study of melatonin in children and adolescents - MORPHEUS

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-002187-31-DK

Enrollment

Registered

2021-09-29

Start date

2021-11-19

Completion date

Unknown

Last updated

2024-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy children and adolescents MedDRA version: 22.0 Level: SOC Classification code 10022891 Term: Investigations System Organ Class: 10022891 - Investigations

Interventions

Trade Name: Melatonin AGB Product Name: Melatonin AGB tabletter Pharmaceutical Form: Tablet INN or Proposed INN: Melatonin CAS Number: 73-31-4

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Healthy subjects aged 3-17 years of age (both inclusive) who are able to swallow tablets of 9.5 mm 2. Signed informed consent form Are the trial subjects under 18? yes Number of subjects for this age range: 36 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Diagnosis of a neurodevelopmental disorder 2. Participation in other studies that may interfere with results 3. If the investigator finds that the child is not eligible due to other diseases, cannot co-operate etc. 4. Hereditary fructose intolerance 5. Intake of medications that may interfere with the results i.e. Fluvoxamine, psoralenes, cimetidine, estrogens, quinolones, rifampicin, carbamezapine. 6. Unable to avoid caffeine, alcohol or nicotine 24 hours prior to study 7. Pregnancy (Pregnancy tests will be performed in girls from 12 years of age with menarche) 8. BMI for age outside the limits of ± 2SD (15) 9. Dental work in the last 24 hours

Design outcomes

Primary

Measure	Time frame
Main Objective: This study aims to examine the pharmacokinetics of melatonin in different dosages in a broad paediatric age group to optimize treatment. Participants are given regular release melatonin 1,3 and 5 mg. ;Secondary Objective: Secondary objectives: Adverse events Tolerability evaluated by the modified Wong Baker scale Genetic variance in CYP1A2 The effect of puberty on melatonin metabolism ;Primary end point(s): To assess the pharmacokinetic parameters Cmax, relative bioavailability of oral melatonin (Frel), AUC0-inf, AUC0-t, CL/F, t½, and tmax in salivary samples of healthy children and adolescents after single doses.;Timepoint(s) of evaluation of this end point: At each of the 4 visits 7 saliva samples will be obtained in one of two sampling groups. A: Baseline, 15 min, 40 min, 60 min, 120 min, 240 min and 360 min B: Baseline, 30 min, 50 min, 75 min, 180 min, 300 min, 420 min	—

Measure

Time frame

Main Objective: This study aims to examine the pharmacokinetics of melatonin in different dosages in a broad paediatric age group to optimize treatment. Participants are given regular release melatonin 1,3 and 5 mg. ;Secondary Objective: Secondary objectives: Adverse events Tolerability evaluated by the modified Wong Baker scale Genetic variance in CYP1A2 The effect of puberty on melatonin metabolism ;Primary end point(s): To assess the pharmacokinetic parameters Cmax, relative bioavailability of oral melatonin (Frel), AUC0-inf, AUC0-t, CL/F, t½, and tmax in salivary samples of healthy children and adolescents after single doses.;Timepoint(s) of evaluation of this end point: At each of the 4 visits 7 saliva samples will be obtained in one of two sampling groups. A: Baseline, 15 min, 40 min, 60 min, 120 min, 240 min and 360 min B: Baseline, 30 min, 50 min, 75 min, 180 min, 300 min, 420 min

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Secondary

Measure	Time frame
Secondary end point(s): Secondary outcomes 1. Adverse events registration 2. DLMO melatonin concentrations 3. Acceptability 4. Genotyping for CYP1A2 *1F alleles 5. Pharmacokinetic parameters compared between pre-pubertal and pubertal children ;Timepoint(s) of evaluation of this end point: Adverse events and Acceptability are assessed at all visits. Genotyping, DLMO and Tanner score (puberty) are assessed at visit 1 only.	—

Measure

Time frame

Secondary end point(s): Secondary outcomes 1. Adverse events registration 2. DLMO melatonin concentrations 3. Acceptability 4. Genotyping for CYP1A2 *1F alleles 5. Pharmacokinetic parameters compared between pre-pubertal and pubertal children ;Timepoint(s) of evaluation of this end point: Adverse events and Acceptability are assessed at all visits. Genotyping, DLMO and Tanner score (puberty) are assessed at visit 1 only.

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Countries

Denmark

Contacts

Public ContactNanette Debes

Department of Paediatrics

nanette.marinette.monique.debes@regionh.dk004538681151

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026