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

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

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

Study Overview

• Status: Completed
• Conditions: Sleep Disorders; Neurodevelopmental Disorder
• Intervention / Treatment: Drug: 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 Type: Interventional
• Enrollment (Actual): 99
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NPC-15 Granule; NPC-15 granule 1 mg, 2 mg or 4 mg once a day, administered orally before going to bed.	Drug: NPC-15; NPC-15, Melatonin granule 1 mg, 2 mg or 4 mg, once a day, is administered orally before going to bed for 26 weeks after a screening phase of 2 weeks with placebo administration.; Other Names: Melatonin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep latency with electronic sleep diary at week 10.	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.	10 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nobelpharma

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2016
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): July 6, 2018

Study Registration Dates

• First Submitted: April 27, 2016
• First Submitted That Met QC Criteria: April 27, 2016
• First Posted (Estimate): April 29, 2016

Study Record Updates

• Last Update Posted (Actual): April 16, 2019
• Last Update Submitted That Met QC Criteria: April 14, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Melatonin; Sleep disorders; NPC-15; Neurodevelopmental disorder; Sleep latency; DSM-5
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Disease; Sleep Wake Disorders; Parasomnias; Neurodevelopmental Disorders; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Protective Agents; Antioxidants; Melatonin
• Other Study ID Numbers: NPC-15-6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No