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Clinical trialNCT01906866CompletedPhase 3Interventional

Efficacy and Safety of Circadin® in the Treatment of Sleep Disturbances in Children With Neurodevelopment Disabilities

SponsorNeurim Pharmaceuticals Ltd.Enrollment125Sleep Disorders
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The purpose of this study is to establish the efficacy and safety of Circadin in children with neurodevelopmental disorders and to determine the dose, this randomized, placebo-controlled study is planned to evaluate the efficacy of a double-blind, 13 week treatment period with Circadin 2/5mg in improving maintenance of sleep, sleep latency and additional parameters in children with neurodevelopmental disabilities. The efficacy and safety of Circadin 2/5 mg will continue to be assessed during an open-label extension period of 13 weeks.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

28 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Finland
  • Helsinki Sleep Clinic Vitalmed Oy

    Helsinki, Finland

France
  • Hospital Raymond Poincare

    Garches, France

  • Strasbourg University Hospital Depatment of Child Psychiatry & Neurology

    Strasbourg, France

Netherlands
  • Yulius Mental Health Organization

    Dordrecht, Netherlands

  • Hospital Gelderse Vallei

    Ede, Netherlands

  • University Medical Center Groningen

    Groningen, Netherlands

United Kingdom
  • Birmingham Childrens Hospital Nhs Foundation Trust

    Birmingham, United Kingdom

  • Blackpool Victoria Teaching Hospitals Nhs Foundation Trust

    Blackpool, United Kingdom

  • Guy'S & St. Thomas'S Nhs Foundation Trust of St Thomas'S Hospital

    London, United Kingdom

  • University Hospital Southampton Nhs Foundation Trust

    Southampton, United Kingdom

United States
  • Southwest Autism Research and Resource Center (sarrc)

    Phoenix, Arizona, United States

  • Crystal Biomedical Research, Llc

    Miami Lakes, Florida, United States

  • Lake Mary Pediatrics

    Orange City, Florida, United States

  • Mate Lazlo

    West Palm Beach, Florida, United States

  • Attalla Consultants Llc, Dba Institue for Behabiovral Medicine

    Smyrna, Georgia, United States

  • Amr Baber Research Inc

    Naperville, Illinois, United States

  • Kennedy Krieger Institute

    Baltimore, Maryland, United States

  • Child Neurology Specialists/ Crcn

    Henderson, Nevada, United States

  • Clinical Research Center of New Jersey, Llc

    Voorhees Township, New Jersey, United States

  • Geinsinger Clinic

    Danville, Pennsylvania, United States

  • the Children'S Hospital of Philadelphia

    Philadelphia, Pennsylvania, United States

  • Vanderbilt University

    Nashville, Tennessee, United States

  • Insite Clinical Research

    DeSoto, Texas, United States

  • Red Oak Psychiatry Associates

    Houston, Texas, United States

  • Road Runner Research, Ltd

    San Antonio, Texas, United States

  • Sleep Therapy & Research Center

    San Antonio, Texas, United States

  • Ericksen Research & Development

    Clinton, Utah, United States

  • Pacific Institute of Medical Science

    Bothell, Washington, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Circadin 2/5/10 mgPlacebo
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Oct 2013
Primary completion
27 Mar 2018
Completion
27 Mar 2018
Last update posted
23 Apr 2024
Registered enrollment
125
Registry id
NCT01906866

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.