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Verification of the Efficacy of NPC-15 for Sleep Disorders of Children With Autism Spectrum Disorders (NPC-15-5)

Primary Purpose

Sleep Disorders, Autism Spectrum Disorder

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

NPC-15 Granules Lower Dose

NPC-15 Granules Higher Dose

NPC-15 Placebo Granule

About this trial

This is an interventional treatment trial for Sleep Disorders focused on measuring Melatonin, NPC-15, Sleep disorders, Autism spectrum disorders, DSM-5

Eligibility Criteria

6 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

NPC-15 Granules Lower Dose

NPC-15 Granules Higher Dose

NPC-15 Placebo Granule

Arm Description

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

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

NPC-15 Placebo Granules group which is administered placebo melatonin

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Sleep latency measured by actigraphy

To assess the efficacy of this drug in detail

Abnormal behavior checklist Japanese version

To assess effects of this drug on neurodevelopment disorders

Adverse events

To assess safety of this drug

Electro cardiogram

To assess safety of this drug

Full Information

NCT ID

NCT02757066

First Posted

April 27, 2016

Last Updated

April 14, 2019

Sponsor

Nobelpharma

1. Study Identification

Unique Protocol Identification Number

NCT02757066

Brief Title

Verification of the Efficacy of NPC-15 for Sleep Disorders of Children With Autism Spectrum Disorders

Acronym

NPC-15-5

Official Title

Phase II/III Clinical Trial of NPC-15 - Verification of the Efficacy for Sleep Disorders of Children With Autism Spectrum Disorders -

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

June 16, 2016 (Actual)

Primary Completion Date

September 2018 (Actual)

Study Completion Date

September 14, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nobelpharma

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

This study will be a multicenter, double-blind, randomized, placebo-controlled parallel group trial. The trial has five phases; the pre-screening phase, the screening phase, double-blinded treatment phase, open label treatment phase and post-treatment phase. The screening phase comprises a screening visit where subject's initial eligibility will be evaluated. During double-blinded treatment phase, patients who meet all entry criteria for the trial will be randomized into three groups, and they will be assigned NPC-15 1 mg, 4 mg or placebo before going to bed for 2 weeks. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Disorders, Autism Spectrum Disorder

Keywords

Melatonin, NPC-15, Sleep disorders, Autism spectrum disorders, DSM-5

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

196 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NPC-15 Granules Lower Dose

Arm Type

Experimental

Arm Description

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

Arm Title

NPC-15 Granules Higher Dose

Arm Type

Experimental

Arm Description

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

Arm Title

NPC-15 Placebo Granule

Arm Type

Placebo Comparator

Arm Description

NPC-15 Placebo Granules group which is administered placebo melatonin

Intervention Type

Drug

Intervention Name(s)

NPC-15 Granules Lower Dose

Other Intervention Name(s)

Melatonin 1mg

Intervention Description

NPC-15 granule which contains 1mg melatonin

Intervention Type

Drug

Intervention Name(s)

NPC-15 Granules Higher Dose

Other Intervention Name(s)

Melatonin 4mg

Intervention Description

Melatonin granule which contains 4 mg melatonin

Intervention Type

Drug

Intervention Name(s)

NPC-15 Placebo Granule

Other Intervention Name(s)

Placebo

Intervention Description

Melatonin placebo granule which does not contains melatonin.

Primary Outcome Measure Information:

Title

Sleep latency with electronic sleep diary

Description

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.

Time Frame

Week 2

Secondary Outcome Measure Information:

Title

Sleep latency measured by actigraphy

Description

To assess the efficacy of this drug in detail

Time Frame

Week 2

Title

Abnormal behavior checklist Japanese version

Description

To assess effects of this drug on neurodevelopment disorders

Time Frame

Week 2, 9

Title

Adverse events

Description

To assess safety of this drug

Time Frame

10 weeks

Title

Electro cardiogram

Description

To assess safety of this drug

Time Frame

10 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yushiro Yamashita, MD, PhD

Organizational Affiliation

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

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

32912180

Citation

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.

Results Reference

derived

Learn more about this trial

Verification of the Efficacy of NPC-15 for Sleep Disorders of Children With Autism Spectrum Disorders

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