drugset / Trial / NCT02757066

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

NCT02757066

Phase 2/3 Completed 196 enrolled Nobelpharma
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2016-06-16
Primary completion
2018-09
Completion
2018-09-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Melatonin Small molecule 1 mg Oral
Subject Melatonin Small molecule 2 mg Oral
Subject Melatonin Small molecule 4 mg Oral