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

Phase 2

Completed

• Conditions: Autism Spectrum Disorder; Sleep Disorders
• Interventions: Drug: NPC-15 Granules Lower Dose; Drug: NPC-15 Placebo Granule; Drug: NPC-15 Granules Higher Dose

• Registration Number: NCT02757066
• Lead Sponsor: Nobelpharma

Brief 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.

Detailed Description

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 Timeline

• Study First Submitted: 2016-04-27
• Study First Submitted QC: 2016-04-27
• Study First Posted: 2016-04-29
• Study Start: 2016-06-16
• Primary Completion: 2018-09
• Study Completion: 2018-09-14
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-14
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 196

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NPC-15 Granules Lower Dose	NPC-15 Granules Lower Dose	NPC-15 Granules Lower Dose group which is administered 1mg melatonin
NPC-15 Placebo Granule	NPC-15 Placebo Granule	NPC-15 Placebo Granules group which is administered placebo melatonin
NPC-15 Granules Higher Dose	NPC-15 Granules Higher Dose	NPC-15 Granules Higher Dose group which is administered 4 mg melatonin

Primary Outcome Measures

Name	Time	Method
Sleep latency with electronic sleep diary	Week 2	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.

Secondary Outcome Measures

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