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

Study Overview
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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.

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.

Official Title
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Phase II/III Clinical Trial of NPC-15 - Verification of the Efficacy for Sleep Disorders of Children With Autism Spectrum Disorders -

Conditions
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Sleep Disorders, Autism Spectrum Disorder

Intervention / Treatment
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* Drug: NPC-15 Granules Lower Dose
* Drug: NPC-15 Granules Higher Dose
* Drug: NPC-15 Placebo Granule


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NPC-15 Granules Lower Dose<br>NPC-15 Granules Lower Dose group which is administered 1mg melatonin | Drug: NPC-15 Granules Lower Dose<br>* NPC-15 granule which contains 1mg melatonin<br>* Other names: Melatonin 1mg;|
| Experimental: NPC-15 Granules Higher Dose<br>NPC-15 Granules Higher Dose group which is administered 4 mg melatonin | Drug: NPC-15 Granules Higher Dose<br>* Melatonin granule which contains 4 mg melatonin<br>* Other names: Melatonin 4mg;|
| Placebo Comparator: NPC-15 Placebo Granule<br>NPC-15 Placebo Granules group which is administered placebo melatonin | Drug: NPC-15 Placebo Granule<br>* Melatonin placebo granule which does not contains melatonin.<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Week 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep latency measured by actigraphy | To assess the efficacy of this drug in detail | Week 2 | 
| Abnormal behavior checklist Japanese version | To assess effects of this drug on neurodevelopment disorders | Week 2, 9 | 
| Adverse events | To assess safety of this drug | 10 weeks | 
| Electro cardiogram | To assess safety of this drug | 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Melatonin, NPC-15, Sleep disorders, Autism spectrum disorders, DSM-5