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 range

30 Years – 70 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety of OXB-102 as measured by incidence of treatment emergent adverse events and serious adverse events

Timeframe: 3 months timepoint

Safety of OXB-102 as measured by changes in clinical laboratory analysis

Timeframe: 3 months timepoint

Safety of OXB-102 as measured by changes in vital signs

Timeframe: 3 months timepoint

Safety of OXB-102 as measured by changes in brain MRI findings

Timeframe: 3 months timepoint

Safety of OXB-102 as measured by changes in physical examination

Timeframe: 3 months timepoint

Trial details

NCT IDNCT03720418

SponsorSio Gene Therapies

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-04-12

View on ClinicalTrials.gov More Parkinson Disease trials

Who can participate

Age range

30 Years – 70 Years

Sex

ALL

See this in plain English?

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

What they're measuring

Safety of OXB-102 as measured by incidence of treatment emergent adverse events and serious adverse events

Timeframe: 3 months timepoint

Safety of OXB-102 as measured by changes in clinical laboratory analysis

Timeframe: 3 months timepoint

Safety of OXB-102 as measured by changes in vital signs

Timeframe: 3 months timepoint

Safety of OXB-102 as measured by changes in brain MRI findings

Timeframe: 3 months timepoint

Safety of OXB-102 as measured by changes in physical examination

Timeframe: 3 months timepoint