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

• Status: Completed
• Trial end date: 2018-09-14
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nobelpharma
• Treatments: Melatonin

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.