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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.
This study will be a multicenter, double-blind, randomized, placebo-controlled parallel group trial. The trial has five phases; the pre-screening phase, the screening phase, double-blinded treatment phase, open label treatment phase and post-treatment phase. The screening phase comprises a screening visit where subject's initial eligibility will be evaluated. During double-blinded treatment phase, patients who meet all entry criteria for the trial will be randomized into three groups, and they will be assigned NPC-15 1 mg, 4 mg or placebo before going to bed for 2 weeks. 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 Granules Lower Dose | Experimental | NPC-15 Granules Lower Dose group which is administered 1mg melatonin |
|
| NPC-15 Granules Higher Dose | Experimental | NPC-15 Granules Higher Dose group which is administered 4 mg melatonin |
|
| NPC-15 Placebo Granule | Placebo Comparator | NPC-15 Placebo Granules group which is administered placebo melatonin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NPC-15 Granules Lower Dose | Drug | NPC-15 granule which contains 1mg melatonin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sleep latency with electronic sleep diary | 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. | Week 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep latency measured by actigraphy | To assess the efficacy of this drug in detail | Week 2 |
| 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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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32912180 | Derived | Yuge K, Nagamitsu S, Ishikawa Y, Hamada I, Takahashi H, Sugioka H, Yotsuya O, Mishima K, Hayashi M, Yamashita Y. Long-term melatonin treatment for the sleep problems and aberrant behaviors of children with neurodevelopmental disorders. BMC Psychiatry. 2020 Sep 10;20(1):445. doi: 10.1186/s12888-020-02847-y. |
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| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D000067877 | Autism Spectrum Disorder |
| 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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| NPC-15 Granules Higher Dose | Drug | Melatonin granule which contains 4 mg melatonin |
|
|
| NPC-15 Placebo Granule | Drug | Melatonin placebo granule which does not contains melatonin. |
|
|
| Week 2, 9 |
| Adverse events | To assess safety of this drug | 10 weeks |
| Electro cardiogram | To assess safety of this drug | 10 weeks |
| D001523 | Mental Disorders |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |