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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NPC-15 Granule | Experimental | NPC-15 granule 1 mg, 2 mg or 4 mg once a day, administered orally before going to bed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NPC-15 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep latency with electronic sleep diary at week 26. | To assess the efficacy of this drug in detail | 26 weeks |
| Abnormal behavior checklist Japanese version | To assess effects of this drug on neurodevelopment disorders |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yushiro Yamashita, MD, PhD | The Department of Pediatrics and Child Health Kurume University School of Medicine | Principal Investigator |
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| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D065886 | Neurodevelopmental Disorders |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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|
| Week 10, 26 |
| Adverse events | To assess safety of this drug | 28 weeks |
| Laboratory findings, vital sign | To assess safety of this drug | 28 weeks |
| Electro cardiogram | To assess safety of this drug | 28 weeks |
| D001523 | Mental Disorders |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |