The purpose of this study is to evaluate the efficacy on sleep latency with electronic sleep diaries and the safety of NPC-15.
This study will be a multicenter and open label trial. The trial has three phases; the screening phase, treatment phase and post-treatment phase. The screening phase comprises a screening visit where subject's initial eligibility will be evaluated. 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
99
NPC-15, Melatonin granule 1 mg, 2 mg or 4 mg, once a day, is administered orally before going to bed for 26 weeks after a screening phase of 2 weeks with placebo administration.
Sleep latency with electronic sleep diary at week 10.
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.
Time frame: 10 weeks
Sleep latency with electronic sleep diary at week 26.
To assess the efficacy of this drug in detail
Time frame: 26 weeks
Abnormal behavior checklist Japanese version
To assess effects of this drug on neurodevelopment disorders
Time frame: Week 10, 26
Adverse events
To assess safety of this drug
Time frame: 28 weeks
Laboratory findings, vital sign
To assess safety of this drug
Time frame: 28 weeks
Electro cardiogram
To assess safety of this drug
Time frame: 28 weeks
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