Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-01-01 @ 6:36 AM
Study NCT ID:
NCT05897957
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-12
First Post:
2023-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continued Evaluation of Patients With Parkinson's Disease Who Previously Received BRT-DA01
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}], 'ancestors': [{'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Biomarkers for PD may be explored'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-11', 'studyFirstSubmitDate': '2023-06-01', 'studyFirstSubmitQcDate': '2023-06-01', 'lastUpdatePostDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse Events', 'timeFrame': 'Baseline through 5 years post-transplantation', 'description': 'AEs related to the cellular drug product'}, {'measure': 'Change in modified Schwab and England Activities of Daily Living (mSEADL) scale', 'timeFrame': 'Baseline through 5 years post-transplantation', 'description': 'Change in mSEADL'}, {'measure': 'Change in brain atrophy using MRI', 'timeFrame': 'Baseline through 5 years post-transplantation', 'description': 'Change in brain atrophy using MRI'}, {'measure': "Subjects using alternative advanced treatment options in Parkin's Disease", 'timeFrame': 'Baseline through 5 years post-transplantation', 'description': 'Number of subjects using alternative advanced treatment options in PD (eg, CSAI, LCIG, DBS, focused ultrasound ablation)'}], 'primaryOutcomes': [{'measure': 'Total SAEs and total number of subjects with at least 1 SAE', 'timeFrame': 'Baseline through 5 years post-transplantation', 'description': 'Total SAEs and total number of subjects with at least 1 SAE related to cellular drug product'}], 'secondaryOutcomes': [{'measure': 'Change in striatal 18F-DOPA uptake using positron emission tomography (PET)', 'timeFrame': 'Baseline through 5 years post-transplantation', 'description': 'Change in striatal 18F-DOPA uptake using positron emission tomography (PET)'}, {'measure': 'Change in Hauser PD diary measurements', 'timeFrame': 'Baseline through 5 years post-transplantation', 'description': 'Change in Hauser PD diary measurements'}, {'measure': "Change in the International Parkinson and Movement Disorder Society (MDS)-Unified Parkinson's Disease Rating Scale (UPDRS)", 'timeFrame': 'Baseline through 5 years post-transplantation', 'description': 'Change in the MDS-UPDRS'}, {'measure': 'Change in levodopa equivalent daily dose (LEDD)', 'timeFrame': 'Baseline through 5 years post-transplantation', 'description': 'Change in LEDD'}, {'measure': "Change in Parkinson's Disease Questionnaire-39 (PDQ-39) summary index", 'timeFrame': 'Baseline through 5 years post-transplantation', 'description': 'Change in PDQ-39'}, {'measure': 'Change in the Unified Dyskinesia Rating Scale (UDysRS)', 'timeFrame': 'Baseline through 5 years post-transplantation', 'description': 'Change in UDysRS'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Parkinson Disease', 'Parkinsonian Disorders', 'Basal Ganglia Diseases', 'Brain Diseases', 'Central Nervous System Diseases', 'Nervous System Diseases', 'Movement Disorders', 'Synucleinopathies', 'Neurodegenerative Diseases'], 'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': 'This is a multicenter study to evaluate the safety and clinical outcomes of BRT-DA01 in subjects with PD who previously received BRT-DA01 in the Phase 1 Study MSK-DA01-101.No investigational therapy will be administered in this study.', 'detailedDescription': 'All subjects who received BRT-DA01 transplantation in Study MSK-DA01-101 (ie, parent study) will be asked to enroll in Study BRT-DA01-501. Subjects enrolled in this study are to be monitored for safety and clinical outcomes through 5 years post-BRT-DA01 transplantation. For individual participating subjects, the Baseline visit for the BRT-DA01-501 study will be defined as the last observation recorded in the parent study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '78 Years', 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Advanced Parkinson's Disease who previously received BRT-DA01 in the Phase 1 Study MSK-DA01-101", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject received BRT-DA01 in Study MSK-DA01-101 (ie, parent study) and will have completed or discontinued the parent study\n* Subject must be willing and able to provide written informed consent for the BRT-DA0-501 study in accordance with applicable regulations and guidelines and to comply with all study visits and procedures\n\nExclusion Criteria:\n\n* No exclusion criteria'}, 'identificationModule': {'nctId': 'NCT05897957', 'briefTitle': "Continued Evaluation of Patients With Parkinson's Disease Who Previously Received BRT-DA01", 'organization': {'class': 'INDUSTRY', 'fullName': 'BlueRock Therapeutics'}, 'officialTitle': "Continued Evaluation of Patients With Parkinson's Disease Who Previously Received BRT-DA01, a Human Embryonic Stem Cell-Derived Midbrain Dopaminergic Neuronal Cell Therapy", 'orgStudyIdInfo': {'id': 'BRT-DA01-501'}}, 'contactsLocationsModule': {'locations': [{'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Irvine', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medical College', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': 'M5T 2S8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto Western Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Nauman Abid, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'BlueRock Therapeutics LP'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BlueRock Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}