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Verification of the Efficacy of NPC-15 for Sleep Disorders of Children With Autism Spectrum Disorders

NCT02757066 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2019-04-16

No results posted yet for this study

Summary

The purpose of this study is to verify the efficacy of NPC-15 (melatonin 1 mg/d or 4 mg/d) versus placebo to sleep latency with electronic sleep diaries.

Conditions

Interventions

DRUG

NPC-15 Granules Lower Dose

NPC-15 granule which contains 1mg melatonin

DRUG

NPC-15 Granules Higher Dose

Melatonin granule which contains 4 mg melatonin

DRUG

NPC-15 Placebo Granule

Melatonin placebo granule which does not contains melatonin.

Sponsors & Collaborators

  • Nobelpharma

    lead INDUSTRY

Principal Investigators

  • Yushiro Yamashita, MD, PhD · The Department of Pediatrics and Child Health Kurume University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-16
Primary Completion
2018-09-30
Completion
2018-09-14

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Entities

Diseases

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 NCT02757066 on ClinicalTrials.gov