Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:06 AM
Study NCT ID:
NCT07424404
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-20
First Post:
2026-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Long-term Safety and Tolerability of KarXT and KarX-EC for the Treatment of Schizophrenia and Autism-Related Irritability in Adolescents, Respectively
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2030-03-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-13', 'studyFirstSubmitDate': '2026-02-13', 'studyFirstSubmitQcDate': '2026-02-13', 'lastUpdatePostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-03-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with treatment emergent adverse events (TEAEs)', 'timeFrame': 'Up to 54 weeks'}, {'measure': 'Number of participants with adverse events of special interest (AESIs)', 'timeFrame': 'Up to 54 weeks'}, {'measure': 'Number of participants with serious adverse events (SAEs)', 'timeFrame': 'Up to 54 weeks'}], 'secondaryOutcomes': [{'measure': 'Number or participants with procholinergic symptoms', 'timeFrame': 'Up to 54 weeks'}, {'measure': 'Number of participants with anticholinergic symptoms', 'timeFrame': 'Up to 54 weeks'}, {'measure': 'Number of participants with suicidal ideation and behavior assessed using the Columbia Suicide Severity Rating Scale (C-SSRS)', 'timeFrame': 'Up to 54 weeks'}, {'measure': 'Change from baseline on the Simpson-Angus Scale (SAS)', 'timeFrame': 'Up to 52 weeks'}, {'measure': 'Change from baseline on the Abnormal Involuntary Movement Scale (AIMS)', 'timeFrame': 'Up to 52 weeks'}, {'measure': 'Change from baseline on the Barnes-Akathisia Rating Scale (BARS)', 'timeFrame': 'Up to 52 weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Schizophrenia', 'Autism-Related Irritability']}, '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 long-term safety and tolerability of KarXT and KarX-EC for the treatment of Schizophrenia and autism-related irritability in adolescents, respectively'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n\\- Participants must have completed the double-blind treatment period (ie, Visit 8) of Study CN0120020 or the double-blind treatment period (ie, Week 8) of Study CN0120044 or CN0120045, without an adverse event (AE) that, in the investigator\'s opinion, may indicate an unacceptable safety risk.\n\nExclusion Criteria\n\n* Participants must not have a significant risk of committing violent acts, serious self-harm, or attempting suicide based on history or routine psychiatric status examination, or those who are homicidal or are considered to be a high risk to others, or who have an answer of "Yes" on Questions 4 or 5 on the suicidal ideation section of the "Since Last Visit" version of the C-SSRS at baseline (Visit 1). Nonsuicidal, self-injurious behavior is not exclusionary.\n* Participants must not have any clinically significant abnormality including any finding(s) from the physical examination, vital signs, ECG at the end of treatment visit of Study CN0120020, CN0120044, or CN0120045 that the investigator, in consultation with the Sponsor Medical Monitor, would jeopardize the safety of the participant.\n* Participants must not have either a systolic blood pressure (sBP) or diastolic blood pressure (dBP) meeting criteria for stage 2 hypertension (HTN), regardless of the presence or absence of symptoms.\n* Other protocol-defined Inclusion/Exclusion criteria apply.'}, 'identificationModule': {'nctId': 'NCT07424404', 'briefTitle': 'A Study to Evaluate the Long-term Safety and Tolerability of KarXT and KarX-EC for the Treatment of Schizophrenia and Autism-Related Irritability in Adolescents, Respectively', 'organization': {'class': 'INDUSTRY', 'fullName': 'Karuna Therapeutics'}, 'officialTitle': 'A Phase 3 Multicenter, Open-label Study to Assess the Long-term Safety and Tolerability of KarXT in Adolescents (13 to 17 Years of Age) With Schizophrenia and KarXT+KarX-EC in Children and Adolescents (5 to 17 Years of Age) With Irritability Associated With Autism Spectrum Disorder', 'orgStudyIdInfo': {'id': 'CN012-0021'}, 'secondaryIdInfos': [{'id': '2025-524062-16-00', 'type': 'OTHER', 'domain': 'EU CT Number'}, {'id': 'U1111-1325-9994', 'type': 'OTHER', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Administration of KarXT for Schizophrenia', 'interventionNames': ['Drug: KarXT']}, {'type': 'EXPERIMENTAL', 'label': 'Administration of KarXT for Autism-related Irritability', 'interventionNames': ['Drug: KarXT']}], 'interventions': [{'name': 'KarXT', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Administration of KarXT for Autism-related Irritability', 'Administration of KarXT for Schizophrenia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92805', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Site 0077', 'role': 'CONTACT'}], 'facility': 'Local Institution - 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