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

Autism Spectrum Disorder Clinical Trial

— 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 -

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02757066
• Other study ID #: NPC-15-5
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: June 16, 2016
• Est. completion date: September 14, 2018

Study information

• Verified date: April 2019
• Source: Nobelpharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: September 14, 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive
• Disease
• Parasomnias
• Sleep Disorders
• Sleep Wake Disorders

Intervention

Drug:
• NPC-15 Granules Lower Dose
NPC-15 granule which contains 1mg melatonin
• NPC-15 Granules Higher Dose
Melatonin granule which contains 4 mg melatonin
• NPC-15 Placebo Granule
Melatonin placebo granule which does not contains melatonin.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nobelpharma

Outcome

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