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

NCT02757079 | Completed Phase 3

• 1 other identifier: NPC-15-6
• Study Type: interventional
• Target: 99
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sleep Disorders; Neurodevelopmental Disorder

Keywords

Melatonin; NPC-15; Sleep disorders; Neurodevelopmental disorder; Sleep latency; DSM-5

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Sleep latency with electronic sleep diary at week 26.

  26 weeks

• Abnormal behavior checklist Japanese version

  Week 10, 26

• Adverse events

  28 weeks

• Laboratory findings, vital sign

  28 weeks

• Electro cardiogram

  28 weeks

Study Arms (1)

NPC-15 Granule

EXPERIMENTAL

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

Drug: NPC-15

Interventions

NPC-15 DRUG

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.

Also known as: Melatonin

NPC-15 Granule

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nobelpharma: lead

MeSH Terms

Conditions

Sleep Wake Disorders; Neurodevelopmental Disorders

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Yushiro Yamashita, MD, PhD

  The Department of Pediatrics and Child Health Kurume University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2016
• First Posted: April 29, 2016
• Study Start: June 21, 2016
• Primary Completion: July 1, 2018
• Study Completion: July 6, 2018
• Last Updated: April 16, 2019

Record last verified: 2019-04