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

Phase 3

Completed

• Conditions: Sleep Disorders; Neurodevelopmental Disorder
• Interventions: Drug: NPC-15

• Registration Number: NCT02757079
• Lead Sponsor: Nobelpharma

Brief Summary

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

Detailed 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 Timeline

• Study First Submitted: 2016-04-27
• Study First Submitted QC: 2016-04-27
• Study First Posted: 2016-04-29
• Study Start: 2016-06-21
• Primary Completion: 2018-07
• Study Completion: 2018-07-06
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-14
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

• Female or male patients aged 6 to 15 years.
• Patients with "neurodevelopmental 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 " the most 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: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NPC-15 Granule	NPC-15	NPC-15 granule 1 mg, 2 mg or 4 mg once a day, administered orally before going to bed.

Primary Outcome Measures

Name	Time	Method
Sleep latency with electronic sleep diary at week 10.	10 weeks	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 with electronic sleep diary at week 26.	26 weeks	To assess the efficacy of this drug in detail
Abnormal behavior checklist Japanese version	Week 10, 26	To assess effects of this drug on neurodevelopment disorders
Adverse events	28 weeks	To assess safety of this drug
Laboratory findings, vital sign	28 weeks	To assess safety of this drug
Electro cardiogram	28 weeks	To assess safety of this drug