Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT03720418
Status:
TERMINATED
Last Update Posted:
2022-05-03
First Post:
2018-10-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of OXB-102 (AXO-Lenti-PD) in Patients With Bilateral, Idiopathic Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Study Part A open-label and Study Part B randomized, double-blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'whyStopped': 'As a result of termination of development of OXB-102-01, it is no longer possible for Sio to either commence or to continue any related clinical trials.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-10-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-04-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-27', 'studyFirstSubmitDate': '2018-10-16', 'studyFirstSubmitQcDate': '2018-10-24', 'lastUpdatePostDateStruct': {'date': '2022-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of OXB-102 as measured by incidence of treatment emergent adverse events and serious adverse events', 'timeFrame': '3 months timepoint', 'description': 'Treatment emergent adverse events and serious adverse events will be assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, for severity'}, {'measure': 'Safety of OXB-102 as measured by changes in clinical laboratory analysis', 'timeFrame': '3 months timepoint', 'description': 'Number of clinically significant changes in clinical laboratory analysis'}, {'measure': 'Safety of OXB-102 as measured by changes in vital signs', 'timeFrame': '3 months timepoint', 'description': 'Number of clinically significant changes in vital signs'}, {'measure': 'Safety of OXB-102 as measured by changes in brain MRI findings', 'timeFrame': '3 months timepoint', 'description': 'Number of clinically significant changes in brain MRI findings'}, {'measure': 'Safety of OXB-102 as measured by changes in physical examination', 'timeFrame': '3 months timepoint', 'description': 'Number of clinically significant changes in physical examination'}], 'secondaryOutcomes': [{'measure': 'Change in Unified Parkinson\'s Disease Rating Scale (UPDRS) scores defined in "OFF" and "ON" medication states', 'timeFrame': 'Baseline to 6 months'}, {'measure': 'Change in "OFF" time during waking day compared to baseline as assessed by participant diaries', 'timeFrame': 'Baseline to 6 months'}, {'measure': 'Change in dyskinesia rating scale score', 'timeFrame': 'Baseline to 6 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Parkinson's disease", 'Gene therapy', 'OXB-102', 'AXO-Lenti-PD'], 'conditions': ['Parkinson Disease']}, 'referencesModule': {'references': [{'pmid': '31127735', 'type': 'DERIVED', 'citation': "McFarthing K, Prakash N, Simuni T. CLINICAL TRIAL HIGHLIGHTS: 1. GENE THERAPY FOR PARKINSON'S, 2. PHASE 3 STUDY IN FOCUS - INTEC PHARMA'S ACCORDION PILL, 3. CLINICAL TRIALS RESOURCES. J Parkinsons Dis. 2019;9(2):251-264. doi: 10.3233/JPD-199001. No abstract available."}]}, 'descriptionModule': {'briefSummary': "This study consists of two parts. Part A will evaluate the safety and tolerability of multiple doses of OXB-102 (AXO-Lenti-PD) in participants with Parkinson's disease. Part B will assess the safety and efficacy of the selected dose of OXB-102 in participants with Parkinson's disease.", 'detailedDescription': 'This study consists of two parts. Part A is an open-label dose-escalation phase in which participants are enrolled in cohorts and will receive one of approximately three escalating doses of OXB-102 (AXO-Lenti-PD). Part B is a randomized, double-blind phase in which participants will be randomized to either an active group receiving the selected dose from Part A, or to a control group receiving an imitation surgical procedure (ISP).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1. Diagnosed with bilateral idiopathic PD\n2. Males/females between 30 and 70 years at the time of surgery\n3. Unified Parkinson\'s Disease Rating Scale (UPDRS) (Part III) score of between 30 and 60 in the "OFF" medication state\n4. Presence of motor fluctuations and/or dyskinetic movement\n5. Candidate for surgical intervention\n6. Hoehn and Yahr (H\\&Y) Stage 3 or 4 in the "OFF" medication state\n7. Stable dosing of PD medication, including L-DOPA, for four weeks prior to screening with Levodopa equivalent daily dose (LEDD) of at least 900 mg\n\nKey Exclusion Criteria:\n\n1. History of psychosis or current treatment with dopamine blocking agents and prior regular exposure to antipsychotic agents\n2. History of stereotactic or other surgery for the treatment of PD, including Deep Brain Stimulation (DBS)\n3. Participation in a prior cell or gene transfer therapy study\n4. Contraindications to use of anaesthesia\n5. Current or anticipated treatment with anticoagulant therapy or the use of anticoagulation therapy that cannot be temporarily stopped around the time of surgery\n6. Diagnosis of multiple system atrophy\n7. Abnormal MRI findings such as mega cisterna, septum pellucidum, signs of severe cortical or subcortical atrophy, brain tumours, vascular diseases, trauma or arteriovenous malformations\n8. Presence of dementia'}, 'identificationModule': {'nctId': 'NCT03720418', 'acronym': 'SUNRISE-PD', 'briefTitle': "Study of OXB-102 (AXO-Lenti-PD) in Patients With Bilateral, Idiopathic Parkinson's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Sio Gene Therapies'}, 'officialTitle': "A Phase I/II Safety and Dose Evaluation Study of OXB-102 (AXO-Lenti-PD) in Patients With Bilateral Idiopathic Parkinson's Disease (SUNRISE-PD)", 'orgStudyIdInfo': {'id': 'OXB-102-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OXB-102 Dose Level 1', 'description': 'OXB-102 Dose Level 1 Single Administration (Part A: open-label)', 'interventionNames': ['Drug: OXB-102']}, {'type': 'EXPERIMENTAL', 'label': 'OXB-102 Dose Level 2', 'description': 'OXB-102 Dose Level 2 Single Administration (Part A: open-label)', 'interventionNames': ['Drug: OXB-102']}, {'type': 'EXPERIMENTAL', 'label': 'OXB-102 Dose Level 3', 'description': 'OXB-102 Dose Level 3 Single Administration (Part A: open-label)', 'interventionNames': ['Drug: OXB-102']}, {'type': 'EXPERIMENTAL', 'label': 'OXB-102 Selected Dose', 'description': 'Selected Dose of OXB-102 Single Administration (Part B: double-blind)', 'interventionNames': ['Drug: OXB-102']}, {'type': 'SHAM_COMPARATOR', 'label': 'Imitation Surgical Procedure', 'description': 'General anesthesia with bilateral skin incisions (Part B: double-blind)', 'interventionNames': ['Other: Imitation Surgical Procedure (ISP)']}], 'interventions': [{'name': 'OXB-102', 'type': 'DRUG', 'otherNames': ['AXO-Lenti-PD'], 'description': 'Neurosurgical delivery of OXB-102 (gene therapy) to the putamen', 'armGroupLabels': ['OXB-102 Dose Level 1', 'OXB-102 Dose Level 2', 'OXB-102 Dose Level 3', 'OXB-102 Selected Dose']}, {'name': 'Imitation Surgical Procedure (ISP)', 'type': 'OTHER', 'description': 'Participants randomized to the control group in Part B will receive an ISP', 'armGroupLabels': ['Imitation Surgical Procedure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94010', 'city': 'Créteil', 'country': 'France', 'facility': 'Service de Neurochirurgie, Hôpital Henri Mondor', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': 'CB2 0PY,', 'city': 'Cambridge', 'state': 'Cambridgeshire', 'country': 'United Kingdom', 'facility': 'University of Cambridge, Centre for Brain Repair', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'WC1N 3BG', 'city': 'London', 'country': 'United Kingdom', 'facility': 'The National Hospital for Neurology and Neurosurgery', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Erika De Boever, DDS, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sio Gene Therapies'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sio Gene Therapies', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}