MedTrace Logo

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

NCT01906866 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2024-04-23

Study results available
· View outcomes & findings →

Summary

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.

Conditions

  • Sleep Disorders

Interventions

DRUG

Circadin 2/5/10 mg

Circadin 2/5/10 mg. Active arm

DRUG

Placebo

Control arm

Sponsors & Collaborators

  • Neurim Pharmaceuticals Ltd.

    lead INDUSTRY

Principal Investigators

  • Paul Gringras, PhD · Thoma's Hospital, Westminster Bridge Rd, London

  • Robert Findling, MD · Kennedy Krieger Institute, Baltimore, Maryland, USA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2018-03-27
Completion
2018-03-27

Countries

  • United States
  • Finland
  • France
  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01906866 on ClinicalTrials.gov