Ignite Creation Date:
2025-12-24 @ 4:07 PM
Ignite Modification Date:
2026-02-24 @ 3:52 AM
Study NCT ID:
NCT02757066
Status:
COMPLETED
Last Update Posted:
2019-04-16
First Post:
2016-04-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Verification of the Efficacy of NPC-15 for Sleep Disorders of Children With Autism Spectrum Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008550', 'term': 'Melatonin'}], 'ancestors': [{'id': 'D014363', 'term': 'Tryptamines'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 196}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-09-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-14', 'studyFirstSubmitDate': '2016-04-27', 'studyFirstSubmitQcDate': '2016-04-27', 'lastUpdatePostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sleep latency with electronic sleep diary', 'timeFrame': 'Week 2', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Sleep latency measured by actigraphy', 'timeFrame': 'Week 2', 'description': 'To assess the efficacy of this drug in detail'}, {'measure': 'Abnormal behavior checklist Japanese version', 'timeFrame': 'Week 2, 9', 'description': 'To assess effects of this drug on neurodevelopment disorders'}, {'measure': 'Adverse events', 'timeFrame': '10 weeks', 'description': 'To assess safety of this drug'}, {'measure': 'Electro cardiogram', 'timeFrame': '10 weeks', 'description': 'To assess safety of this drug'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Melatonin', 'NPC-15', 'Sleep disorders', 'Autism spectrum disorders', 'DSM-5'], 'conditions': ['Sleep Disorders', 'Autism Spectrum Disorder']}, 'referencesModule': {'references': [{'pmid': '32912180', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female or male patients aged 6 to 15 years.\n* Patients with "autism spectrum disorder" diagnosed by using DSM-5.\n* Patients with average of daily sleep latency persisted over 30 min and the condition is continuous over 3 months\n* Patients who are out-patient, not hospitalized patient.\n* 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.\n\nExclusion Criteria:\n\n* 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.\n* Patients who took melatonin (including supplement) in history.\n* Patients who had taken Ramelteon within 4 weeks before clinical study starts.'}, 'identificationModule': {'nctId': 'NCT02757066', 'acronym': 'NPC-15-5', 'briefTitle': 'Verification of the Efficacy of NPC-15 for Sleep Disorders of Children With Autism Spectrum Disorders', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nobelpharma'}, 'officialTitle': 'Phase II/III Clinical Trial of NPC-15 - Verification of the Efficacy for Sleep Disorders of Children With Autism Spectrum Disorders -', 'orgStudyIdInfo': {'id': 'NPC-15-5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NPC-15 Granules Lower Dose', 'description': 'NPC-15 Granules Lower Dose group which is administered 1mg melatonin', 'interventionNames': ['Drug: NPC-15 Granules Lower Dose']}, {'type': 'EXPERIMENTAL', 'label': 'NPC-15 Granules Higher Dose', 'description': 'NPC-15 Granules Higher Dose group which is administered 4 mg melatonin', 'interventionNames': ['Drug: NPC-15 Granules Higher Dose']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'NPC-15 Placebo Granule', 'description': 'NPC-15 Placebo Granules group which is administered placebo melatonin', 'interventionNames': ['Drug: NPC-15 Placebo Granule']}], 'interventions': [{'name': 'NPC-15 Granules Lower Dose', 'type': 'DRUG', 'otherNames': ['Melatonin 1mg'], 'description': 'NPC-15 granule which contains 1mg melatonin', 'armGroupLabels': ['NPC-15 Granules Lower Dose']}, {'name': 'NPC-15 Granules Higher Dose', 'type': 'DRUG', 'otherNames': ['Melatonin 4mg'], 'description': 'Melatonin granule which contains 4 mg melatonin', 'armGroupLabels': ['NPC-15 Granules Higher Dose']}, {'name': 'NPC-15 Placebo Granule', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'Melatonin placebo granule which does not contains melatonin.', 'armGroupLabels': ['NPC-15 Placebo Granule']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Yushiro Yamashita, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Department of Pediatrics and Child Health Kurume University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nobelpharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}