Study of the Efficacy and Safety of NPC-15 for Sleep Disorders of Children With Neurodevelopmental Disorders

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy on sleep latency with electronic sleep diaries and the safety of NPC-15.

Detailed Description
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This study will be a multicenter and open label trial. The trial has three phases; the screening phase, treatment phase and post-treatment phase. The screening phase comprises a screening visit where subject's initial eligibility will be evaluated. 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 III Clinical Trial of NPC-15 - Study of the Efficacy and Safety for Sleep Disorders of Children With Neurodevelopmental Disorders -

Conditions
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Sleep Disorders, Neurodevelopmental Disorder

Intervention / Treatment
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* Drug: NPC-15


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 neurodevelopmental 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  the most 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NPC-15 Granule<br>NPC-15 granule 1 mg, 2 mg or 4 mg once a day, administered orally before going to bed. | Drug: NPC-15<br>* NPC-15, Melatonin granule 1 mg, 2 mg or 4 mg, once a day, is administered orally before going to bed for 26 weeks after a screening phase of 2 weeks with placebo administration.<br>* Other names: Melatonin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep latency with electronic sleep diary at week 10. | 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. | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep latency with electronic sleep diary at week 26. | To assess the efficacy of this drug in detail | 26 weeks | 
| Abnormal behavior checklist Japanese version | To assess effects of this drug on neurodevelopment disorders | Week 10, 26 | 
| Adverse events | To assess safety of this drug | 28 weeks | 
| Laboratory findings, vital sign | To assess safety of this drug | 28 weeks | 
| Electro cardiogram | To assess safety of this drug | 28 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, Neurodevelopmental disorder, Sleep latency, DSM-5