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

Nobelpharma196 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

196

Conditions

Sleep Disorders Autism Spectrum Disorder

Interventions

NPC-15 Granules Lower DoseDRUG

NPC-15 granule which contains 1mg melatonin

NPC-15 Granules Higher DoseDRUG

Melatonin granule which contains 4 mg melatonin

NPC-15 Placebo GranuleDRUG

Melatonin placebo granule which does not contains melatonin.

Eligibility

Sex: ALLMin age: 6 YearsMax age: 15 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Sleep latency with electronic sleep diary

Sleep latency is a common endpoint in sleep disorders. In addition, it has been used in a randomized clinical study of sleep disorders of children with neurodevelopmental disorders.

Time frame: Week 2

Secondary Outcomes

Sleep latency measured by actigraphy

To assess the efficacy of this drug in detail

Time frame: Week 2

Abnormal behavior checklist Japanese version

To assess effects of this drug on neurodevelopment disorders

Time frame: Week 2, 9

Adverse events

To assess safety of this drug

Time frame: 10 weeks

Electro cardiogram

To assess safety of this drug

Time frame: 10 weeks

Data from ClinicalTrials.gov

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