Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-30 @ 9:31 AM
Study NCT ID:
NCT06963034
Status:
RECRUITING
Last Update Posted:
2025-12-15
First Post:
2025-04-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NBI-1117568-SCZ3029: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 284}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-12', 'studyFirstSubmitDate': '2025-04-30', 'studyFirstSubmitQcDate': '2025-04-30', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 5', 'timeFrame': 'Baseline, Week 5'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 5', 'timeFrame': 'Baseline, Week 5'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'The primary objective for this study is to evaluate the efficacy of NBI-1117568 compared with placebo on improving behavioral and psychological symptoms of schizophrenia in adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Participant has a primary diagnosis of schizophrenia\n* Participant is experiencing an acute exacerbation or relapse of symptoms and currently warrants hospitalization.\n* Participants taking prohibited medications, including antipsychotics, must discontinue before study participation\n* Participant is willing and able to remain in an inpatient setting for the study duration, follow instructions, and comply with the protocol requirements\n\nKey Exclusion Criteria:\n\n* Participant has known hypersensitivity to any component of the formulation of NBI-1117568.\n* Participant has an unstable or poorly controlled medical condition or chronic disease\n* Participant is considered by the investigator to be at imminent risk of suicide or injury to self or others\n* Participant has a diagnosis of moderate or severe substance use disorder (with the exception of nicotine or caffeine dependence) within 6 months prior to screening\n* Participant has a positive alcohol test or drug screen for disallowed substances\n* Participants have a history of poor or suspected poor compliance in clinical research studies and/or in the investigator's opinion, the participant is not capable of adhering to the protocol requirements.\n\nNote: Other protocol-specified inclusion/exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT06963034', 'briefTitle': 'NBI-1117568-SCZ3029: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Neurocrine Biosciences'}, 'officialTitle': 'A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of NBI-1117568 in Adults With Schizophrenia Who Warrant Inpatient Hospitalization', 'orgStudyIdInfo': {'id': 'NBI-1117568-SCZ3029'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NBI-1117568', 'description': 'Participants will receive NBI-1117568 once daily (QD) orally from Day 1 to Day 35 for a total of 5 weeks.', 'interventionNames': ['Drug: NBI-1117568']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive matching placebo QD orally from Day 1 to Day 35 for a total of 5 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'NBI-1117568', 'type': 'DRUG', 'description': 'NBI-1117568 will be administered per schedule specified in the arm description.', 'armGroupLabels': ['NBI-1117568']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo will be administered per schedule specified in the arm description.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92805', 'city': 'Anaheim', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '90660', 'city': 'Pico Rivera', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 33.98307, 'lon': -118.09673}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '91403', 'city': 'Sherman Oaks', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 34.15112, 'lon': -118.44925}}, {'zip': '90504', 'city': 'Torrance', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '33024', 'city': 'Hollywood', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '33016', 'city': 'Miami Lakes', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '30331', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30030', 'city': 'Decatur', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '30071', 'city': 'Peachtree Corners', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 33.9701, 'lon': -84.22159}}, {'zip': '60640', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '20877', 'city': 'Gaithersburg', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 39.14344, 'lon': -77.20137}}, {'zip': '02472', 'city': 'Watertown', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 42.37093, 'lon': -71.18283}}, {'zip': '08053', 'city': 'Marlton', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 39.89122, 'lon': -74.92183}}, {'zip': '10314', 'city': 'Staten Island', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 40.56233, 'lon': -74.13986}}, {'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '78754', 'city': 'Austin', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75115', 'city': 'DeSoto', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 32.58986, 'lon': -96.85695}}], 'centralContacts': [{'name': 'Neurocrine Medical Information Call Center', 'role': 'CONTACT', 'email': 'medinfo@neurocrine.com', 'phone': '877-641-3461'}], 'overallOfficials': [{'name': 'Clinical Development Lead', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Neurocrine Biosciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neurocrine Biosciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}