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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-16

Study Completion Date

2018-09-14

Brief Summary

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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.

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Detailed Description

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This study will be a multicenter, double-blind, randomized, placebo-controlled parallel group trial. The trial has five phases; the pre-screening phase, the screening phase, double-blinded treatment phase, open label treatment phase and post-treatment phase. The screening phase comprises a screening visit where subject's initial eligibility will be evaluated. During double-blinded treatment phase, patients who meet all entry criteria for the trial will be randomized into three groups, and they will be assigned NPC-15 1 mg, 4 mg or placebo before going to bed for 2 weeks. During open label treatment phase, all patients will be administered NPC-15 1 mg, 2 mg or 4 mg on the basis of their doctors' judgements.

Conditions

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Sleep Disorders Autism Spectrum Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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NPC-15 Granules Lower Dose

NPC-15 Granules Lower Dose group which is administered 1mg melatonin

Group Type EXPERIMENTAL

NPC-15 Granules Lower Dose

Intervention Type DRUG

NPC-15 granule which contains 1mg melatonin

NPC-15 Granules Higher Dose

NPC-15 Granules Higher Dose group which is administered 4 mg melatonin

Group Type EXPERIMENTAL

NPC-15 Granules Higher Dose

Intervention Type DRUG

Melatonin granule which contains 4 mg melatonin

NPC-15 Placebo Granule

NPC-15 Placebo Granules group which is administered placebo melatonin

Group Type PLACEBO_COMPARATOR

NPC-15 Placebo Granule

Intervention Type DRUG

Melatonin placebo granule which does not contains melatonin.

Interventions

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NPC-15 Granules Lower Dose

NPC-15 granule which contains 1mg melatonin

Intervention Type DRUG

NPC-15 Granules Higher Dose

Melatonin granule which contains 4 mg melatonin

Intervention Type DRUG

NPC-15 Placebo Granule

Melatonin placebo granule which does not contains melatonin.

Intervention Type DRUG

Other Intervention Names

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Melatonin 1mg Melatonin 4mg Placebo

Eligibility Criteria

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Inclusion Criteria

* Female or male patients aged 6 to 15 years.
* Patients with "autism spectrum disorder" diagnosed by using DSM-5.
* Patients with average of daily sleep latency persisted over 30 min and the condition is continuous over 3 months
* Patients who are out-patient, not hospitalized patient.
* Signed informed consent obtained from rearer(s)/parent(s)/guardian(s) of the patient, or signed IC or informed assent obtained from the patient themselves.

Exclusion Criteria

* Patients with at least severity in either Conceptual area, or Social area, or Practical area of intellectual disability have judged more than "severe" by using DSM-5.
* Patients who took melatonin (including supplement) in history.
* Patients who had taken Ramelteon within 4 weeks before clinical study starts.

Minimum Eligible Age

6 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No