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A Randomized, Placebo-controlled Study to Investigate the Efficacy and Safety of Circadin to Alleviate Sleep Disturbances in Children With Neurodevelopmental Disabilities

Trial Profile

A Randomized, Placebo-controlled Study to Investigate the Efficacy and Safety of Circadin to Alleviate Sleep Disturbances in Children With Neurodevelopmental Disabilities

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Nov 2021

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At a glance

  • Drugs Melatonin (Primary)
  • Indications Insomnia; Sleep disorders
  • Focus Registrational; Therapeutic Use
  • Sponsors NEURIM Pharmaceuticals
  • Most Recent Events

    • 05 Nov 2018 According to a Neurim Pharmaceuticals media release, SLENYTO(PEDPRM) WAS APPROVED BY EMA FOR THE TREATMENT OF INSOMNIA IN CHILDREN AND ADOLESCENTS AGED 2-18 WITH AUTISM SPECTRUM DISORDER (ASD) AND / OR SMITH-MAGENIS SYNDROME, WHERE SLEEP HYGIENE MEASURES HAVE BEEN INSUFFICIENT
    • 30 Jul 2018 Results presented in a Neurim Pharmaceuticals media release.
    • 30 Jul 2018 According to a Neurim Pharmaceuticals media release, the CHMP recommendation is based on results of Slenyto comprehensive data package demonstrating short and long-term (2 years) efficacy and safety of this child-appropriate, easy-to-swallow drug for insomnia in ASD children.
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