NCT02757066

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
196

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 29, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

June 16, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2018

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

2.2 years

First QC Date

April 27, 2016

Last Update Submit

April 14, 2019

Conditions

Sleep DisordersAutism Spectrum Disorder

Keywords

MelatoninNPC-15Sleep disordersAutism spectrum disordersDSM-5

Outcome Measures

Primary Outcomes (1)

  • Sleep latency with electronic sleep diary

    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.

    Week 2

Secondary Outcomes (4)

  • Sleep latency measured by actigraphy

    Week 2

  • Abnormal behavior checklist Japanese version

    Week 2, 9

  • Adverse events

    10 weeks

  • Electro cardiogram

    10 weeks

Study Arms (3)

NPC-15 Granules Lower Dose

EXPERIMENTAL

NPC-15 Granules Lower Dose group which is administered 1mg melatonin

Drug: NPC-15 Granules Lower Dose

NPC-15 Granules Higher Dose

EXPERIMENTAL

NPC-15 Granules Higher Dose group which is administered 4 mg melatonin

Drug: NPC-15 Granules Higher Dose

NPC-15 Placebo Granule

PLACEBO COMPARATOR

NPC-15 Placebo Granules group which is administered placebo melatonin

Drug: NPC-15 Placebo Granule

Interventions

NPC-15 Granules Lower DoseDRUG

NPC-15 granule which contains 1mg melatonin

Also known as: Melatonin 1mg
NPC-15 Granules Lower Dose
NPC-15 Granules Higher DoseDRUG

Melatonin granule which contains 4 mg melatonin

Also known as: Melatonin 4mg
NPC-15 Granules Higher Dose
NPC-15 Placebo GranuleDRUG

Melatonin placebo granule which does not contains melatonin.

Also known as: Placebo
NPC-15 Placebo Granule

Eligibility Criteria

Age6 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Female or male patients aged 6 to 15 years.
  • Patients with "autism spectrum 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 "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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Yuge K, Nagamitsu S, Ishikawa Y, Hamada I, Takahashi H, Sugioka H, Yotsuya O, Mishima K, Hayashi M, Yamashita Y. Long-term melatonin treatment for the sleep problems and aberrant behaviors of children with neurodevelopmental disorders. BMC Psychiatry. 2020 Sep 10;20(1):445. doi: 10.1186/s12888-020-02847-y.

    PMID: 32912180DERIVED

MeSH Terms

Conditions

Sleep Wake DisordersAutism Spectrum Disorder

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Nervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersChild Development Disorders, PervasiveNeurodevelopmental Disorders

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, 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 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2016

First Posted

April 29, 2016

Study Start

June 16, 2016

Primary Completion

September 1, 2018

Study Completion

September 14, 2018

Last Updated

April 16, 2019

Record last verified: 2019-04