Study of OXB-102 (AXO-Lenti-PD) in Patients With Bilateral, Idiopathic Parkinson's Disease (NCT03720418) | Clinical Trial Compass
TerminatedPhase 1/2
Study of OXB-102 (AXO-Lenti-PD) in Patients With Bilateral, Idiopathic Parkinson's Disease
Stopped: 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.
France, United Kingdom6 participantsStarted 2018-10-17
Plain-language summary
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.
Who can participate
Age range30 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Diagnosed with bilateral idiopathic PD
✓. Males/females between 30 and 70 years at the time of surgery
✓. Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) score of between 30 and 60 in the "OFF" medication state
✓. Presence of motor fluctuations and/or dyskinetic movement
✓. Candidate for surgical intervention
✓. Hoehn and Yahr (H\&Y) Stage 3 or 4 in the "OFF" medication state
✓. 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
Exclusion criteria
✕. History of psychosis or current treatment with dopamine blocking agents and prior regular exposure to antipsychotic agents
✕. History of stereotactic or other surgery for the treatment of PD, including Deep Brain Stimulation (DBS)
✕. Participation in a prior cell or gene transfer therapy study
✕. Contraindications to use of anaesthesia
✕. Current or anticipated treatment with anticoagulant therapy or the use of anticoagulation therapy that cannot be temporarily stopped around the time of surgery
✕
What they're measuring
1
Safety of OXB-102 as measured by incidence of treatment emergent adverse events and serious adverse events
Timeframe: 3 months timepoint
2
Safety of OXB-102 as measured by changes in clinical laboratory analysis
Timeframe: 3 months timepoint
3
Safety of OXB-102 as measured by changes in vital signs
Timeframe: 3 months timepoint
4
Safety of OXB-102 as measured by changes in brain MRI findings
Timeframe: 3 months timepoint
5
Safety of OXB-102 as measured by changes in physical examination
✕. Abnormal MRI findings such as mega cisterna, septum pellucidum, signs of severe cortical or subcortical atrophy, brain tumours, vascular diseases, trauma or arteriovenous malformations