Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OXB-102 Dose Level 1 | Experimental | OXB-102 Dose Level 1 Single Administration (Part A: open-label) |
|
| OXB-102 Dose Level 2 | Experimental | OXB-102 Dose Level 2 Single Administration (Part A: open-label) |
|
| OXB-102 Dose Level 3 | Experimental | OXB-102 Dose Level 3 Single Administration (Part A: open-label) |
|
| OXB-102 Selected Dose | Experimental | Selected Dose of OXB-102 Single Administration (Part B: double-blind) |
|
| Imitation Surgical Procedure | Sham Comparator | General anesthesia with bilateral skin incisions (Part B: double-blind) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OXB-102 | Drug | Neurosurgical delivery of OXB-102 (gene therapy) to the putamen |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of OXB-102 as measured by incidence of treatment emergent adverse events and serious adverse events | 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 | 3 months timepoint |
| Safety of OXB-102 as measured by changes in clinical laboratory analysis | Number of clinically significant changes in clinical laboratory analysis | 3 months timepoint |
| Safety of OXB-102 as measured by changes in vital signs | Number of clinically significant changes in vital signs | 3 months timepoint |
| Safety of OXB-102 as measured by changes in brain MRI findings | Number of clinically significant changes in brain MRI findings | 3 months timepoint |
| Safety of OXB-102 as measured by changes in physical examination | Number of clinically significant changes in physical examination | 3 months timepoint |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Unified Parkinson's Disease Rating Scale (UPDRS) scores defined in "OFF" and "ON" medication states | Baseline to 6 months | |
| Change in "OFF" time during waking day compared to baseline as assessed by participant diaries | Baseline to 6 months |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Erika De Boever, DDS, PhD | Sio Gene Therapies | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Neurochirurgie, Hôpital Henri Mondor | Créteil | 94010 | France | |||
| University of Cambridge, Centre for Brain Repair |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31127735 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Study Part A open-label and Study Part B randomized, double-blind
|
| Imitation Surgical Procedure (ISP) | Other | Participants randomized to the control group in Part B will receive an ISP |
|
| Change in dyskinesia rating scale score | Baseline to 6 months |
| Cambridge |
| Cambridgeshire |
| CB2 0PY, |
| United Kingdom |
| The National Hospital for Neurology and Neurosurgery | London | WC1N 3BG | United Kingdom |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |