Anorexia NervosaPhase 3MELSomAnorexiaNCT07576764
Pediatric Prolonged-Release Melatonin for Sleep Disturbances in Children and Adolescents With Anorexia Nervosa (MELSom-ANOREXIA)
A Phase 3 study testing Pediatric Prolonged-Released Melatonin (PedPRM) in people with Anorexia Nervosa and Sleep Disorders in Children, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Sleep disturbances are reported by more than 50% of patients with Anorexia Nervosa (AN) and are associated with increased AN severity, psychiatric comorbidities, and poorer quality of life. To date, no pharmacological treatment has been approved or recommended for sleep disorders in children and adolescents with AN. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Anorexia Nervosa, Sleep Disorders in Children
- What is being tested?
- Pediatric Prolonged-Released Melatonin (PedPRM)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2026to 1 Jan 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participants aged 6 to 18 years, inclusive, with a diagnosis of Anorexia Nervosa (AN) according to DSM-5 criteria Presence of a sleep problem for at least 1 month, defined as ≤ 6 hours of continuous sleep and/or ≥ 0.5 hours sleep latency from lights-off on 3 out of 5 nights, based on participant report (with or without parental assistance according to age), confirmed at D0 by 2-week sleep diary No response to at least 4 weeks of sleep hygiene Negative pregnancy test at baseline, prior to randomization, for female participants of childbearing potential Women of childbearing potential must agree to use a highly effective method of contraception during the study treatment period and for at least 4 weeks after the last dose of study treatment Written informed consent obtained in accordance with the participant's legal status and applicable regulations Affiliation to a social security system or equivalent
Who cannot join
- Known diagnosis of another significant sleep disorder (e.g. moderate to severe sleep apnea) Use of prohibited medication (z-drugs, melatonin agonist, benzodiazepine, phenylpiperazine class, clomethiazole) or melatonin within 2 weeks prior to screening Declared allergy to melatonin, lactose, or any excipient included in the therapeutic units Pregnant or breastfeeding female participants Unresponsiveness to previous prolonged-release melatonin within the 2 years prior to the study Start of cognitive behavioural therapy (CBT) targeting sleep disturbances or mood disorders within 6 weeks before study inclusion Trans-meridian travel (> 2 time zones) within the month before the start of the study Patient under legal protection regimen
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
AP-HM Hopital Salvator
Marseille
Flora BAT-PITAULT, +33491745857, flora.bat@ap-hm.fr
About this study
Official title: Efficacy of Pediatric Prolonged-Release Melatonin (PedPRM) Treatment in Children and Adolescents With Impaired Sleep and Anorexia Nervosa (AN)
Sleep disturbances are reported by more than 50% of patients with Anorexia Nervosa (AN) and are associated with increased AN severity, psychiatric comorbidities, and poorer quality of life. To date, no pharmacological treatment has been approved or recommended for sleep disorders in children and adolescents with AN. Many drugs are currently prescribed off-label for their sedative side effects, without proven safety or efficacy in this population.
Pediatric prolonged-release melatonin (PedPRM, Slenyto®) is the only melatonin formulation approved by the European Medicines Agency (EMA) for chronic insomnia in children aged 2 to 18 years with neurodevelopmental disorders. Its excellent safety profile, absence of tolerance, and long-acting formulation make it a prime candidate for treating sleep disturbances in children and adolescents with AN.
Read more
MELSom-ANOREXIA is a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase IIIb trial. Its primary objective is to assess the efficacy of PedPRM compared to placebo in improving Total Sleep Time (TST) in children and adolescents aged 6 to 18 years with AN and impaired sleep.
Participants are randomized into two groups: the experimental group receives PedPRM (2 mg or 5 mg depending on response at Day 22) and the control group receives a matching placebo, both administered 0.5 to 1 hour before habitual bedtime for 13 weeks. Sleep is assessed by Sleep Diary and actigraphy. Secondary outcomes include other sleep parameters, AN severity (BMI, EDI-2, EDE-Q), associated symptoms (anxiety, depression, physical activity, executive function, emotionality), and quality of life. Melatonin secretion profiles and specific subgroups (ASD traits, early-onset AN) are also explored.
The study includes a 2-week run-in period (D-14 to D0) for baseline sleep assessment, followed by 13 weeks of treatment, with visits at D0, D22, and D93. A total of 120 participants will be enrolled across 7 French pediatric psychiatry centers over 24 months.
- Conditions
- Anorexia Nervosa, Sleep Disorders in Children
- Being tested
- Pediatric Prolonged-Released Melatonin (PedPRM), Placebo
- Keywords
- anorexia
- Medical subject headings
- Anorexia Nervosa, Anorexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pediatric Prolonged-Released Melatonin (PedPRM)Drug
Pediatric prolonged-release melatonin mini-tablets (Slenyto® 1 mg and 5 mg, Neurim Pharmaceuticals). Oral administration 0.5 to 1 hour before habitual bedtime every evening for 13 weeks. Initial dose: 2 mg/day (2 × 1 mg tablets). Dose may be increased to 5 mg/day (1 × 5 mg tablet) at Day 22 in case of insufficient sleep improvement.
PlaceboDrug
Matching placebo mini-tablets, identical in appearance and formulation to the PedPRM therapeutic units. Oral administration 0.5 to 1 hour before habitual bedtime every evening for 13 weeks. Number of units adjusted at Day 22 to match the experimental group and maintain blinding.
| Study group | Role | What they receive |
|---|---|---|
| PedPRM (Pediatric Prolonged-Release Melatonin) | Experimental | Participants receive pediatric prolonged-release melatonin (PedPRM, Slenyto®) orally, 0.5 to 1 hour before habitual bedtime, every evening for 13 weeks. Starting dose is 2 mg (2 × 1 mg tablets). At Day 22, dose is increased to 5 mg (1 × 5 mg tablet) in case of insufficient sleep improvement (less than 1 hour improvement in sleep latency and/or total sleep time from baseline). Receives: Drug: Pediatric Prolonged-Released Melatonin (PedPRM) |
| Placebo | Placebo comparator | Participants receive a matching placebo orally, 0.5 to 1 hour before habitual bedtime, every evening for 13 weeks. At Day 22, placebo units are adjusted in the same manner as the experimental group to maintain blinding. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in mean Total Sleep Time (TST) measured by Sleep Diary
Measured: Baseline (Day-14 to Day 0) and end of treatment (Day 78 to Day 93)
Secondary outcomes (11)
Change from baseline in mean Sleep Latency (SL) measured by Sleep Diary
Measured: Baseline and end of treatment (Day 78 to Day 93)
Change from baseline in mean Wake After Sleep Onset (WASO) measured by Sleep Diary
Measured: Baseline and end of treatment (Day 78 to Day 93)
Change from baseline in mean number of awakenings measured by Sleep Diary
Measured: Baseline and end of treatment (Day 78 to Day 93)
Change from baseline in mean Longest Sleep Episode (LSE) measured by Sleep Diary
Measured: Baseline and end of treatment (D78 to D93)
Change from baseline in mean Total Sleep Time
Measured: Baseline and end of treatment (Day 78 to Day 93)
Change from baseline in Body Mass Index (BMI)
Measured: Baseline (Day 0), Day 22 and end of treatment (Day 93)
Change from baseline in Eating Disorder Inventory-2 (EDI-2) total score
Measured: Baseline (Day 0) and end of treatment (Day 93)
Change from baseline in Eating Disorder Examination-Questionnaire (EDE-Q) score
Measured: Baseline (Day 0) and end of treatment (Day 93)
Change from baseline in executive function (BRIEF-P score)
Measured: Baseline (Day 0) and end of treatment (Day 93)
Change from baseline in emotionality (EPN-31 score)
Measured: Baseline (Day 0) and end of treatment (Day 93)
Change from baseline in depressive symptoms (CDI score)
Measured: Baseline (Day 0) and end of treatment (Day 93)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned in a 1:1 ratio to one of two parallel groups: the experimental group receiving pediatric prolonged-release melatonin (PedPRM) and the control group receiving a matching placebo. Treatment is administered for 13 weeks.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- FRANCOIS CREMIEUX, Study director, DIRECTION DE LA RECHERCHE SANTE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07576764
- Sponsor's protocol ID
- RCAPHM23_0329
- Acronym
- MELSomAnorexia
- Status last verified
- Apr 2026
- First submitted
- 27 Apr 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Pediatric Prolonged-Release Melatonin (PedPRM) Treatment in Children and Adolescents With Impaired Sleep and Anorexia Nervosa (AN)
- ClinicalTrials.gov ID
- NCT07576764
- Acronym / sponsor ID
- MELSomAnorexia / RCAPHM23_0329
- Conditions
- Anorexia Nervosa, Sleep Disorders in Children
- Keywords
- anorexia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 8 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sleep disturbances are reported by more than 50% of patients with Anorexia Nervosa (AN) and are associated with increased AN severity, psychiatric comorbidities, and poorer quality of life. To date, no pharmacological treatment has been approved or recommended for sleep disorders in children and adolescents with AN. Many drugs are currently prescribed off-label for their sedative side effects, without proven safety or efficacy in this population.
Pediatric prolonged-release melatonin (PedPRM, Slenyto®) is the only melatonin formulation approved by the European Medicines Agency (EMA) for chronic insomnia in children aged 2 to 18 years with neurodevelopmental disorders. Its excellent safety profile, absence of tolerance, and long-acting formulation make it a prime candidate for treating sleep disturbances in children and adolescents with AN.
MELSom-ANOREXIA is a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase IIIb trial. Its primary objective is to assess the efficacy of PedPRM compared to placebo in improving Total Sleep Time (TST) in children and adolescents aged 6 to 18 years with AN and impaired sleep.
Participants are randomized into two groups: the experimental group receives PedPRM (2 mg or 5 mg depending on response at Day 22) and the control group receives a matching placebo, both administered 0.5 to 1 hour before habitual bedtime for 13 weeks. Sleep is assessed by Sleep Diary and actigraphy. Secondary outcomes include other sleep parameters, AN severity (BMI, EDI-2, EDE-Q), associated symptoms (anxiety, depression, physical activity, executive function, emotionality), and quality of life. Melatonin secretion profiles and specific subgroups (ASD traits, early-onset AN) are also explored.
The study includes a 2-week run-in period (D-14 to D0) for baseline sleep assessment, followed by 13 weeks of treatment, with visits at D0, D22, and D93. A total of 120 participants will be enrolled across 7 French pediatric psychiatry centers over 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned in a 1:1 ratio to one of two parallel groups: the experimental group receiving pediatric prolonged-release melatonin (PedPRM) and the control group receiving a matching placebo. Treatment is administered for 13 weeks.
| Arm | Type | Receives |
|---|---|---|
| PedPRM (Pediatric Prolonged-Release Melatonin) | Experimental | Drug: Pediatric Prolonged-Released Melatonin (PedPRM)Participants receive pediatric prolonged-release melatonin (PedPRM, Slenyto®) orally, 0.5 to 1 hour before habitual bedtime, every evening for 13 weeks. Starting dose is 2 mg (2 × 1 mg tablets). At Day 22, dose is increased to 5 mg (1 × 5 mg tablet) in case of insufficient sleep improvement (less than 1 hour improvement in sleep latency and/or total sleep time from baseline). |
| Placebo | Placebo comparator | Drug: PlaceboParticipants receive a matching placebo orally, 0.5 to 1 hour before habitual bedtime, every evening for 13 weeks. At Day 22, placebo units are adjusted in the same manner as the experimental group to maintain blinding. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Participants aged 6 to 18 years, inclusive, with a diagnosis of Anorexia Nervosa (AN) according to DSM-5 criteria Presence of a sleep problem for at least 1 month, defined as ≤ 6 hours of continuous sleep and/or ≥ 0.5 hours sleep latency from lights-off on 3 out of 5 nights, based on participant report (with or without parental assistance according to age), confirmed at D0 by 2-week sleep diary No response to at least 4 weeks of sleep hygiene Negative pregnancy test at baseline, prior to randomization, for female participants of childbearing potential Women of childbearing potential must agree to use a highly effective method of contraception during the study treatment period and for at least 4 weeks after the last dose of study treatment Written informed consent obtained in accordance with the participant's legal status and applicable regulations Affiliation to a social security system or equivalent
Key exclusion criteria (1 listed)
- Known diagnosis of another significant sleep disorder (e.g. moderate to severe sleep apnea) Use of prohibited medication (z-drugs, melatonin agonist, benzodiazepine, phenylpiperazine class, clomethiazole) or melatonin within 2 weeks prior to screening Declared allergy to melatonin, lactose, or any excipient included in the therapeutic units Pregnant or breastfeeding female participants Unresponsiveness to previous prolonged-release melatonin within the 2 years prior to the study Start of cognitive behavioural therapy (CBT) targeting sleep disturbances or mood disorders within 6 weeks before study inclusion Trans-meridian travel (> 2 time zones) within the month before the start of the study Patient under legal protection regimen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pediatric Prolonged-Released Melatonin (PedPRM)Pediatric prolonged-release melatonin mini-tablets (Slenyto® 1 mg and 5 mg, Neurim Pharmaceuticals). Oral administration 0.5 to 1 hour before habitual bedtime every evening for 13 weeks. Initial dose: 2 mg/day (2 × 1 mg tablets). Dose may be increased to 5 mg/day (1 × 5 mg tablet) at Day 22 in case of insufficient sleep improvement. | Drug | PedPRM (Pediatric Prolonged-Release Melatonin) |
| PlaceboMatching placebo mini-tablets, identical in appearance and formulation to the PedPRM therapeutic units. Oral administration 0.5 to 1 hour before habitual bedtime every evening for 13 weeks. Number of units adjusted at Day 22 to match the experimental group and maintain blinding. | Drug | Placebo |
Primary outcome
Change from baseline in mean Total Sleep Time (TST) measured by Sleep Diary
Time frame: Baseline (Day-14 to Day 0) and end of treatment (Day 78 to Day 93)
11 secondary outcomes
Change from baseline in mean Sleep Latency (SL) measured by Sleep Diary
Time frame: Baseline and end of treatment (Day 78 to Day 93)
Change from baseline in mean Wake After Sleep Onset (WASO) measured by Sleep Diary
Time frame: Baseline and end of treatment (Day 78 to Day 93)
Change from baseline in mean number of awakenings measured by Sleep Diary
Time frame: Baseline and end of treatment (Day 78 to Day 93)
Change from baseline in mean Longest Sleep Episode (LSE) measured by Sleep Diary
Time frame: Baseline and end of treatment (D78 to D93)
Change from baseline in mean Total Sleep Time
Time frame: Baseline and end of treatment (Day 78 to Day 93)
Change from baseline in Body Mass Index (BMI)
Time frame: Baseline (Day 0), Day 22 and end of treatment (Day 93)
Change from baseline in Eating Disorder Inventory-2 (EDI-2) total score
Time frame: Baseline (Day 0) and end of treatment (Day 93)
Change from baseline in Eating Disorder Examination-Questionnaire (EDE-Q) score
Time frame: Baseline (Day 0) and end of treatment (Day 93)
Change from baseline in executive function (BRIEF-P score)
Time frame: Baseline (Day 0) and end of treatment (Day 93)
Change from baseline in emotionality (EPN-31 score)
Time frame: Baseline (Day 0) and end of treatment (Day 93)
Change from baseline in depressive symptoms (CDI score)
Time frame: Baseline (Day 0) and end of treatment (Day 93)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
FRANCOIS CREMIEUX study director
DIRECTION DE LA RECHERCHE SANTE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pediatric Prolonged-Released Melatonin (PedPRM) in people with Anorexia Nervosa and Sleep Disorders in Children, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Flora MD PHD BAT-PITAULT (+33491745857, flora.bat@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in mean Total Sleep Time (TST) measured by Sleep Diary (time frame: Baseline (Day-14 to Day 0) and end of treatment (Day 78 to Day 93)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.