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

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

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.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder; Sleep Disorders
• Intervention / Treatment: Drug: NPC-15 Granules Lower Dose; Drug: NPC-15 Granules Higher Dose; Drug: NPC-15 Placebo Granule

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.

• Study Type: Interventional
• Enrollment (Actual): 196
• Phase: Phase 2; 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 "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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: NPC-15 Granules Lower Dose; NPC-15 Granules Lower Dose group which is administered 1mg melatonin	Drug: NPC-15 Granules Lower Dose; NPC-15 granule which contains 1mg melatonin; Other Names: Melatonin 1mg
EXPERIMENTAL: NPC-15 Granules Higher Dose; NPC-15 Granules Higher Dose group which is administered 4 mg melatonin	Drug: NPC-15 Granules Higher Dose; Melatonin granule which contains 4 mg melatonin; Other Names: Melatonin 4mg
PLACEBO_COMPARATOR: NPC-15 Placebo Granule; NPC-15 Placebo Granules group which is administered placebo melatonin	Drug: NPC-15 Placebo Granule; Melatonin placebo granule which does not contains melatonin.; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep latency measured by actigraphy	To assess the efficacy of this drug in detail	Week 2
Abnormal behavior checklist Japanese version	To assess effects of this drug on neurodevelopment disorders	Week 2, 9
Adverse events	To assess safety of this drug	10 weeks
Electro cardiogram	To assess safety of this drug	10 weeks

Collaborators and Investigators

• Sponsor: Nobelpharma

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 16, 2016
• Primary Completion (ACTUAL): September 1, 2018
• Study Completion (ACTUAL): September 14, 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; Autism spectrum disorders; NPC-15; DSM-5
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurodevelopmental Disorders; Disease; Sleep Wake Disorders; Parasomnias; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Protective Agents; Antioxidants; Melatonin
• Other Study ID Numbers: NPC-15-5

Plan for Individual participant data (IPD)

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