Study of the Efficacy and Safety of NPC-15 for Sleep Disorders of Children With Neurodevelopmenta… (NCT02757079) | Clinical Trial Compass
CompletedPhase 3
Study of the Efficacy and Safety of NPC-15 for Sleep Disorders of Children With Neurodevelopmental Disorders
99 participantsStarted 2016-06-21
Plain-language summary
The purpose of this study is to evaluate the efficacy on sleep latency with electronic sleep diaries and the safety of NPC-15.
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 "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.
What they're measuring
1
Sleep latency with electronic sleep diary at week 10.