Verification of the Efficacy of NPC-15 for Sleep Disorders of Children With Autism Spectrum Disorders — NPC-15-5  

Autism Spectrum Disorder Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive
• Disease
• Parasomnias
• Sleep Disorders
• Sleep Wake Disorders

• NCT number: NCT02757066
• Study type: Interventional
• Source: Nobelpharma
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: June 16, 2016
• Completion date: September 14, 2018