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Melatonin CR for the Treatment of Impaired Sleep Maintenance in 4-8 Year Old Children With Autism Spectrum Disorders

NCT01033565 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2023-09-08

Study results available
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Summary

The purpose of this research is to see the effects (good and bad) of Melatonin CR on sleep in 4-8 year old children with autism spectrum disorders and sleep problems.

Conditions

  • Sleep Disorder

Interventions

DRUG

Natrol

5mg of sustained released melatonin. One tablet given 30 minutes prior to bedtime.

Sponsors & Collaborators

  • University of Nebraska

    lead OTHER

Principal Investigators

  • Howard Needelman, MD · University of Nebraska

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-04
Primary Completion
2010-10-01
Completion
2010-10-01

Countries

  • United States

Study Locations

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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 NCT01033565 on ClinicalTrials.gov