Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-26 @ 5:22 AM
Study NCT ID:
NCT07101094
Status:
RECRUITING
Last Update Posted:
2025-12-01
First Post:
2025-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Treatment Satisfaction and KarXT Utilization Registry (RESKU)
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': 'C075257', 'term': 'xanomeline'}, {'id': 'C003330', 'term': 'trospium chloride'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2029-05-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-27', 'studyFirstSubmitDate': '2025-07-23', 'studyFirstSubmitQcDate': '2025-08-01', 'lastUpdatePostDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participant medication preference as assessed by the Preference of Medication (POM) questionnaire', 'timeFrame': 'Month 1, Month 3, Month 6'}, {'measure': 'Participant treatment satisfaction as assessed by the Medication Satisfaction Questionnaire (MSQ)', 'timeFrame': 'Baseline, Month 1, Month 3, Month 6'}], 'secondaryOutcomes': [{'measure': 'Treatment titration plan as described by the treating clinician', 'timeFrame': 'Baseline, Month 1, Month 3, Month 6'}, {'measure': 'Treatment switch plan as described by the treating physician', 'timeFrame': 'Baseline, Month 1, Month 3, Month 6'}, {'measure': 'Treatment dose prescribed', 'timeFrame': 'Baseline, Month 1, Month 3, Month 6'}, {'measure': 'Concomitant medication prescribed', 'timeFrame': 'Baseline, Month 1, Month 3, Month 6'}, {'measure': 'Number of participants who are prescribed a treatment dose change', 'timeFrame': 'Month 1, Month 3, Month 6'}, {'measure': 'Reasons for treatment discontinuation', 'timeFrame': 'Month 1, Month 3, Month 6'}, {'measure': 'Participant baseline clinical characteristics', 'timeFrame': 'Baseline'}, {'measure': 'Participant baseline demographics', 'timeFrame': 'Baseline'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Schizophrenia'], '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.fda.gov/safety/recalls-market-withdrawals-safety-alerts', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to understand treatment preference and satisfaction among adults with schizophrenia in the United States who are prescribed xanomeline and trospium chloride (X/T) therapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will include adults diagnosed with schizophrenia who initiate treatment with xanomeline and trospium chloride (XT) in the US.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged ≥18 years at index date.\n* Have a confirmed diagnosis of schizophrenia before index date.\n* Receipt of an initial prescription order for xanomeline and trospium chloride (XT) and plan to fill and initiate such therapy.\n* Provide a signed and dated Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written informed consent form (ICF) in accordance with regulatory, local, and institutional guidelines.\n* Agree to use an electronic device to record, or provide paper entry of, patient-reported outcomes (in English or Spanish).\n* English or Spanish speaking.\n\nExclusion Criteria:\n\n* Participation in an interventional study within the last 30 days or plan to participate in such study at the time of eligibility screening.\n* Evidence of use of XT prior to time of eligibility screening.'}, 'identificationModule': {'nctId': 'NCT07101094', 'briefTitle': 'Evaluation of Treatment Satisfaction and KarXT Utilization Registry (RESKU)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Real-world Evaluation of Treatment Satisfaction and KarXT Utilization Registry (RESKU)', 'orgStudyIdInfo': {'id': 'CN012-0066'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants receiving xanomeline and trospium chloride (X/T) therapy', 'interventionNames': ['Drug: xanomeline and trospium chloride (X/T) therapy']}], 'interventions': [{'name': 'xanomeline and trospium chloride (X/T) therapy', 'type': 'DRUG', 'description': 'According to the product label', 'armGroupLabels': ['Participants receiving xanomeline and trospium chloride (X/T) therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92866', 'city': 'Orange', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site 0009', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0009', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '95124', 'city': 'San Jose', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site 0010', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0010', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '60201', 'city': 'Evanston', 'state': 'Illinois', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site 0003', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0003', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site 0007', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0007', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21228', 'city': 'Catonsville', 'state': 'Maryland', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site 0004', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0004', 'geoPoint': {'lat': 39.27205, 'lon': -76.73192}}, {'zip': '02478-1064', 'city': 'Belmont', 'state': 'Massachusetts', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site 0008', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0008', 'geoPoint': {'lat': 42.39593, 'lon': -71.17867}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site 0002', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0002', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02747', 'city': 'South Dartmouth', 'state': 'Massachusetts', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site 0011', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0011', 'geoPoint': {'lat': 41.59177, 'lon': -70.94115}}, {'zip': '68144', 'city': 'Omaha', 'state': 'Nebraska', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Vithya Selvaraj, Site 0005', 'role': 'CONTACT', 'phone': '402-991-9630'}], 'facility': 'Omaha Insomnia and Psychiatric Services', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '08502', 'city': 'Belle Mead', 'state': 'New Jersey', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site 0001', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0001', 'geoPoint': {'lat': 40.46677, 'lon': -74.66071}}, {'zip': '29708', 'city': 'Fort Mill', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Brian Mika, Site 0006', 'role': 'CONTACT'}], 'facility': 'Continuum Health Providers', 'geoPoint': {'lat': 35.00737, 'lon': -80.94508}}, {'zip': '79902', 'city': 'El Paso', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site 0012', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0012', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}, {'zip': '75601', 'city': 'Longview', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site 0013', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0013', 'geoPoint': {'lat': 32.5007, 'lon': -94.74049}}], 'centralContacts': [{'name': 'BMS Study Connect Contact Center www.BMSStudyConnect.com', 'role': 'CONTACT', 'email': 'Clinical.Trials@bms.com', 'phone': '855-907-3286'}, {'name': 'First line of the email MUST contain NCT # and Site #.', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Bristol Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}