Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-29 @ 5:57 AM
Study NCT ID:
NCT04712734
Status:
COMPLETED
Last Update Posted:
2023-06-29
First Post:
2021-01-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Iloperidone Long-acting Injection (LAI) for the Treatment of 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C081732', 'term': 'iloperidone'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-27', 'studyFirstSubmitDate': '2021-01-13', 'studyFirstSubmitQcDate': '2021-01-13', 'lastUpdatePostDateStruct': {'date': '2023-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics of iloperidone and its metabolites following repeat-dosing of iloperidone given as a long-acting injection.', 'timeFrame': '24 weeks', 'description': 'As measured by plasma concentrations.'}, {'measure': 'Assessment of safety and tolerability of repeat-dosing of iloperidone given as a long-acting injection.', 'timeFrame': '24 weeks', 'description': 'As measured by spontaneous reporting of adverse events (AEs).'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'This is a multicenter, open-label, adaptive, repeat-dose study to evaluate the safety, tolerability, and pharmacokinetics of iloperidone long-acting injection (LAI) in patients with schizophrenia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willing and able to provide written informed consent.\n* Male or female patients 18 to 65 years of age (inclusive).\n* Clinical diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorder (DSM-5) for at least 1 year.\n* Symptomatically stable within the past two months.\n\nExclusion Criteria:\n\n* Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.\n* Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs.\n* Pregnant or nursing (lactating) women.\n* A positive test for drugs of abuse.'}, 'identificationModule': {'nctId': 'NCT04712734', 'briefTitle': 'A Study to Evaluate Iloperidone Long-acting Injection (LAI) for the Treatment of Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vanda Pharmaceuticals'}, 'officialTitle': 'An Open-label, Adaptive, Repeat-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Iloperidone Long-acting Injection (LAI) in Patients With Schizophrenia', 'orgStudyIdInfo': {'id': 'VP-VYV-683-1005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Iloperidone', 'interventionNames': ['Drug: Iloperidone']}], 'interventions': [{'name': 'Iloperidone', 'type': 'DRUG', 'otherNames': ['VYV-683'], 'description': 'oral tablet, long-acting injection', 'armGroupLabels': ['Iloperidone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92845', 'city': 'Garden Grove', 'state': 'California', 'country': 'United States', 'facility': 'Vanda Investigational Site', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'zip': '20877', 'city': 'Gaithersburg', 'state': 'Maryland', 'country': 'United States', 'facility': 'Vanda Investigational Site', 'geoPoint': {'lat': 39.14344, 'lon': -77.20137}}, {'zip': '08053', 'city': 'Marlton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Vanda Investigational Site', 'geoPoint': {'lat': 39.89122, 'lon': -74.92183}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanda Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}