Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-01-02 @ 8:29 AM
Study NCT ID:
NCT03267303
Status:
COMPLETED
Last Update Posted:
2025-02-28
First Post:
2017-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety and Efficacy of TS-091 in Patients with Narcolepsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009290', 'term': 'Narcolepsy'}], 'ancestors': [{'id': 'D006970', 'term': 'Disorders of Excessive Somnolence'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-08-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-26', 'studyFirstSubmitDate': '2017-08-28', 'studyFirstSubmitQcDate': '2017-08-28', 'lastUpdatePostDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean sleep latency in maintenance of wakefulness test', 'timeFrame': '3 weeks'}], 'secondaryOutcomes': [{'measure': 'Total score on the epworth sleepiness scale', 'timeFrame': '3 weeks'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Narcolepsy'], 'conditions': ['Narcolepsy']}, 'referencesModule': {'references': [{'pmid': '35193545', 'type': 'DERIVED', 'citation': 'Inoue Y, Uchiyama M, Umeuchi H, Onishi K, Ogo H, Kitajima I, Matsushita I, Nishino I, Uchimura N. Optimal dose determination of enerisant (TS-091) for patients with narcolepsy: two randomized, double-blind, placebo-controlled trials. BMC Psychiatry. 2022 Feb 22;22(1):141. doi: 10.1186/s12888-022-03785-7.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the efficacy and safety after administration of TS-091 compared with placebo in patients with narcolepsy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '64 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients diagnosed with narcolepsy type 1 or type 2 based on the International Classification of Sleep Disorders, third edition (ICSD-3) criteria\n2. Patients aged ≥16 to \\<65 years at the time of obtaining informed consent\n3. Outpatients\n\nExclusion Criteria:\n\n1. Patients with sleep disorders other than narcolepsy (e.g., sleep apnea syndrome, periodic limb movement disorder)\n2. Patients with organic brain diseases (including neurodegenerative diseases or cerebrovascular disorders) or epilepsy\n3. Patients with obstructive respiratory diseases (bronchial asthma, emphysema)\n4. Patients with psychiatric disorders (e.g., major depressive disorder, bipolar disorder, schizophrenia)'}, 'identificationModule': {'nctId': 'NCT03267303', 'briefTitle': 'A Study to Evaluate the Safety and Efficacy of TS-091 in Patients with Narcolepsy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Taisho Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Phase II, Double-blind, Parallel-group Comparative Study 2 of TS-091 in Patients with Narcolepsy', 'orgStudyIdInfo': {'id': 'TS091-1701'}, 'secondaryIdInfos': [{'id': 'JapicCTI-173689', 'type': 'OTHER', 'domain': 'JapicCTI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TS-091 5mg', 'interventionNames': ['Drug: TS-091 5mg']}, {'type': 'EXPERIMENTAL', 'label': 'TS-091 10mg', 'interventionNames': ['Drug: TS-091 10mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'TS-091 5mg', 'type': 'DRUG', 'description': 'Orally taken once daily for 3 weeks', 'armGroupLabels': ['TS-091 5mg']}, {'name': 'TS-091 10mg', 'type': 'DRUG', 'description': 'Orally taken once daily for 3 weeks', 'armGroupLabels': ['TS-091 10mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Orally taken once daily for 3 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Osaka and Other Japanese City', 'country': 'Japan', 'facility': 'Taisho Pharmaceutical Co., Ltd selected site'}, {'city': 'Seoul and Other Korean City', 'country': 'South Korea', 'facility': 'Taisho Pharmaceutical Co., Ltd selected site'}], 'overallOfficials': [{'name': 'Shigeru Okuyama', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Taisho Pharmaceutical Co., Ltd.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taisho Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}