Verification of the Efficacy of NPC-15 for Sleep Disorders of Children With Autism Spectrum Disor… (NCT02757066) | Clinical Trial Compass
CompletedPhase 2/3
Verification of the Efficacy of NPC-15 for Sleep Disorders of Children With Autism Spectrum Disorders
196 participantsStarted 2016-06-16
Plain-language 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.
Who can participate
Age range6 Years – 15 Years
SexALL
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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.