Ignite Creation Date:
2025-12-25 @ 2:48 AM
Ignite Modification Date:
2026-03-05 @ 6:03 PM
Study NCT ID:
NCT03062033
Status:
UNKNOWN
Last Update Posted:
2017-11-22
First Post:
2017-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real-World Evaluation Screening Study and Registry of Dyskinesia in Patients Taking Antipsychotic Agents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071057', 'term': 'Tardive Dyskinesia'}], 'ancestors': [{'id': 'D004409', 'term': 'Dyskinesia, Drug-Induced'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2018-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-11-20', 'studyFirstSubmitDate': '2017-02-03', 'studyFirstSubmitQcDate': '2017-02-20', 'lastUpdatePostDateStruct': {'date': '2017-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Customized clinician-reported outcomes', 'timeFrame': '12 months', 'description': 'Clinician evaluation of patient burden due to tardive dyskinesia symptoms'}, {'measure': 'EuroQOL 5 Dimensions EQ-5D-5L)', 'timeFrame': '12 months', 'description': 'General, single index measure for describing and valuing health-related quality of life.'}, {'measure': 'Customized caregiver-reported outcomes:', 'timeFrame': '12 months', 'description': 'Caregiver evaluation of perceived burden of symptoms on patients as well as the impact on the caregiver'}, {'measure': 'Sheehan Disability Scale (SDS)', 'timeFrame': '12 months', 'description': 'Assessment of functional impairment and disability'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Tardive Dyskinesia']}, 'descriptionModule': {'briefSummary': 'Prospective study to quantify the prevalence of possible tardive dyskinesia (TD) in outpatient psychiatry practices in the United States (US), as well as to describe the associated disease burden in a cohort of patients with one or more psychiatric disorders and a cumulative lifetime exposure to antipsychotic medication of three months or more.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients must be 18 years or older with a cumulative lifetime exposure to antipsychotic medication of three months or more.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has a cumulative lifetime exposure to antipsychotic medication of three months or more\n* Patient has a clinician confirmed diagnosis of one or more psychiatric disorder(s), as defined in the DSM-5\n* Patient has a usual care clinic visit scheduled during the study recruitment window (i.e. a pre-defined 2-week period)\n* Patient is able to read and understand English\n* Patient is willing and able to comply with the study requirements\n\nExclusion Criteria:\n\n* Patient is unable to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT03062033', 'acronym': 'RE-Kinect', 'briefTitle': 'Real-World Evaluation Screening Study and Registry of Dyskinesia in Patients Taking Antipsychotic Agents', 'organization': {'class': 'INDUSTRY', 'fullName': 'Neurocrine Biosciences'}, 'officialTitle': 'Real-World Evaluation Screening Study and Registry of Dyskinesia in Patients Taking Antipsychotic Agents', 'orgStudyIdInfo': {'id': 'EVA-19350'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1', 'description': 'Patients without visible signs of involuntary movements (possible TD) at time of clinician assessment'}, {'label': 'Cohort 2', 'description': 'Patients with visible signs of involuntary movements (possible TD) at the time of clinician assessment'}]}, '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': '92804', 'city': 'Anaheim', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '92805', 'city': 'Anaheim', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '90807', 'city': 'Long Beach', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '95030', 'city': 'Los Gatos', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 37.22661, 'lon': -121.97468}}, {'zip': '92056', 'city': 'Oceanside', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'zip': '32607', 'city': 'Gainesville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33018', 'city': 'Hialeah', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '32256', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33173', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33139', 'city': 'Miami Beach', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'zip': '33166', 'city': 'Miami Springs', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 25.82232, 'lon': -80.2895}}, {'zip': '33161', 'city': 'North Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 25.89009, 'lon': -80.18671}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30030', 'city': 'Decatur', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '96817', 'city': 'Honolulu', 'state': 'Hawaii', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '60563', 'city': 'Naperville', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 41.78586, 'lon': -88.14729}}, {'zip': '46360', 'city': 'Michigan City', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 41.70754, 'lon': -86.89503}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '48307', 'city': 'Rochester', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 42.68059, 'lon': -83.13382}}, {'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '63128', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68526', 'city': 'Lincoln', 'state': 'Nebraska', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '03060', 'city': 'Nashua', 'state': 'New Hampshire', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 42.76537, 'lon': -71.46757}}, {'zip': '27707', 'city': 'Durham', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '28601', 'city': 'Hickory', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 35.73319, 'lon': -81.3412}}, {'zip': '44125', 'city': 'Garfield Heights', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 41.417, 'lon': -81.60596}}, {'zip': '73112', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77090', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84105', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '98007', 'city': 'Bellevue', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 47.61038, 'lon': -122.20068}}], 'centralContacts': [{'name': 'Evidera RE-Kinect Registry Team', 'role': 'CONTACT', 'email': 'rekinect@evidera.com', 'phone': '1-800-242-2196'}], 'overallOfficials': [{'name': "Chris O'Brien, MD", 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chief Medical Officer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neurocrine Biosciences', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Evidera', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}