A Phase 1/2 interventional study of OXB-102 and Imitation Surgical Procedure (ISP) in Parkinson Disease, sponsored by Sio Gene Therapies. Terminated at 3 sites in 2 countries. Open to participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-05-03.
Sponsored by Sio Gene Therapies · Phase 1/2, Interventional, and Treatment
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).
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 6 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →This is the only study on the registry with Sio Gene Therapies as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
OXB-102 Dose Level 1 Single Administration (Part A: open-label)
Drug: OXB-102
OXB-102 Dose Level 2 Single Administration (Part A: open-label)
Drug: OXB-102
OXB-102 Dose Level 3 Single Administration (Part A: open-label)
Drug: OXB-102
Selected Dose of OXB-102 Single Administration (Part B: double-blind)
Drug: OXB-102
General anesthesia with bilateral skin incisions (Part B: double-blind)
Other: Imitation Surgical Procedure (ISP)
Neurosurgical delivery of OXB-102 (gene therapy) to the putamen
Also known as: AXO-Lenti-PD
Participants randomized to the control group in Part B will receive an ISP
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
Time frame: 3 months timepoint
Safety of OXB-102 as measured by changes in clinical laboratory analysis
Number of clinically significant changes in clinical laboratory analysis
Time frame: 3 months timepoint
Safety of OXB-102 as measured by changes in vital signs
Number of clinically significant changes in vital signs
Time frame: 3 months timepoint
Safety of OXB-102 as measured by changes in brain MRI findings
Number of clinically significant changes in brain MRI findings
Time frame: 3 months timepoint
Safety of OXB-102 as measured by changes in physical examination
Number of clinically significant changes in physical examination
Time frame: 3 months timepoint
Change in Unified Parkinson's Disease Rating Scale (UPDRS) scores defined in "OFF" and "ON" medication states
Time frame: Baseline to 6 months
Change in "OFF" time during waking day compared to baseline as assessed by participant diaries
Time frame: Baseline to 6 months
Change in dyskinesia rating scale score
Time frame: Baseline to 6 months
Plan to share: No
This study is terminated, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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