Study of the Efficacy and Safety of NPC-15 for Sleep Disorders of Children With Neurodevelopmental Disorders

• Status: Completed
• Trial end date: 2018-07-06
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy on sleep latency with electronic sleep diaries and the safety of NPC-15.

• Phase: 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 "neurodevelopmental 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 " the most 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.