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Study of the Efficacy and Safety of NPC-15 for Sleep Disorders of Children With Neurodevelopmental Disorders — NPC-15-6  

Sleep Disorders Clinical Trial

Official title:
Phase III Clinical Trial of NPC-15 - Study of the Efficacy and Safety for Sleep Disorders of Children With Neurodevelopmental Disorders -

Clinical Trial Summary

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

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02757079
Study type Interventional
Source Nobelpharma
Contact
Status Completed
Phase Phase 3
Start date June 21, 2016
Completion date July 6, 2018
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