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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Placebo: 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 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. 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.

Eligibility

Primary outcome measure(s)

• Change from baseline in mean Total Sleep Time (TST) measured by Sleep Diary — Baseline (Day-14 to Day 0) and end of treatment (Day 78 to Day 93)

Trial sites (1)

More Assistance Publique Hopitaux De Marseille trials in France

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