Pediatric Prolonged-Release Melatonin for Sleep Disturbances in Children and Adolescents With Anorexia Nervosa (MELSom-ANOREXIA)

Sponsor
Assistance Publique Hopitaux De Marseille
Study ID
NCT07576764
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Anorexia Nervosa
  • Sleep Disorders in Children

Eligibility Criteria

Sex
ALL
Age
6 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • Placebo — DRUG
    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 Details

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.

Key Dates

First listed
May 8, 2026
Start date
Sep 1, 2026
Status verified
Apr 2026
Primary completion
Jan 1, 2029
Completion
Jan 1, 2029

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: PedPRM (Pediatric Prolonged-Release Melatonin)
    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 Comparator: Placebo
    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.

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) ]

Central Contacts

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