Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2025-12-25 @ 11:09 PM
Study NCT ID:
NCT07288567
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-12-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Schizophrenia in Adolescents
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': 166}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-27', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-12-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2025-12-16', 'studyFirstSubmitQcDate': '2025-12-16', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2029-12-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score', 'timeFrame': 'Week 5'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score', 'timeFrame': 'Week 5'}, {'measure': 'Change From Baseline in PANSS Positive Subscale Score', 'timeFrame': 'Week 5'}, {'measure': 'Change From Baseline in PANSS Negative Subscale Score', 'timeFrame': 'Week 5'}, {'measure': 'Change From Baseline in PANSS Marder Negative Factor Score', 'timeFrame': 'Week 5'}, {'measure': 'Number of Participants With PANSS Response', 'timeFrame': 'Week 5', 'description': 'PANSS response will be determined by ≥ 30% reduction in PANSS total score.'}, {'measure': 'Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Score', 'timeFrame': 'Week 5'}, {'measure': "Change From Baseline in Children's Global Assessment Scale (CGAS)) Score", 'timeFrame': 'Week 5'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Schizophrenia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.BMSClinicalTrials.com', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of KarXT for treatment of Schizophrenia in adolescents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of schizophrenia as defined by the The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition,Text Revision (DSM-5-TR) criteria, confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime version (K-SADS-PL) and experiencing symptoms of psychosis at screening (Visit 1).\n* PANSS total score of at least 70 at screening (Visit 1) and randomization (Visit 2).\n* Participant has a CGI-S score of ≥ 4 at screening (Visit 1) and randomization (Visit 2).\n\nExclusion Criteria:\n\n* Any primary DSM-5-TR disorder other than schizophrenia within 12 months before screening.\n* History or presence of clinically significant cardiovascular, pulmonary, hepatic impairment, renal, hematologic, GI, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results.\n* All grades of hepatic impairment (mild \\[Child-Pugh Class A\\], moderate \\[Child-Pugh Class B\\], and severe \\[Child-Pugh Class C\\]). Participants with known intellectual disability defined as an IQ less than 70; or, either clinical evidence or known social or school history indicative of intellectual disability.\n* Any neurological disorder, except for Tourette's Syndrome.\n* Participants who have either a systolic blood pressure (sBP) or diastolic blood pressure (dBP) meeting criteria for stage 2 HTN, regardless of the presence or absence of symptoms.\n* Other protocol-defined Inclusion/Exclusion criteria apply."}, 'identificationModule': {'nctId': 'NCT07288567', 'briefTitle': 'A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Schizophrenia in Adolescents', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Schizophrenia in Adolescents (13 to 17 Years of Age)', 'orgStudyIdInfo': {'id': 'CN012-0020'}, 'secondaryIdInfos': [{'id': '2025-523711-11-00', 'type': 'OTHER', 'domain': 'EU CT number'}, {'id': 'U1111-1325-9936', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'KarXT', 'interventionNames': ['Drug: KarXT']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: KarXT Matching Placebo']}], 'interventions': [{'name': 'KarXT', 'type': 'DRUG', 'otherNames': ['BMS-986510'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['KarXT']}, {'name': 'KarXT Matching Placebo', 'type': 'OTHER', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92805', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Site 0077', 'role': 'CONTACT'}], 'facility': 'Local Institution - 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