NCT02757066

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

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 196 (actual)
• Sponsor: Nobelpharma · Industry
• Sex: All
• Age: 6 Years – 15 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sleep Disorders
• Autism Spectrum Disorder

Interventions

Type	Name	Description
DRUG	NPC-15 Granules Lower Dose	NPC-15 granule which contains 1mg melatonin
DRUG	NPC-15 Granules Higher Dose	Melatonin granule which contains 4 mg melatonin
DRUG	NPC-15 Placebo Granule	Melatonin placebo granule which does not contains melatonin.

Timeline

• Start date: 2016-06-16
• Primary completion: 2018-09-01
• Completion: 2018-09-14
• First posted: 2016-04-29
• Last updated: 2019-04-16