At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- AAV2-GDNF gene therapy (drug), control surgery (procedure)
- How long the study runs
- Study runs about 50 months (dates as stated)
- About the drug or intervention
- AAV2-GDNF gene therapy — drug: Bilateral image-guided infusion of AAV2-GDNF into putamen, single dose · control surgery — procedure: Bilateral partial burr/twist holes without dural penetration
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 45 Years to 75 Years
- Who
- All
- Number of participants
- 127
- Started
- 2024-06-11
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for parkinson disease
- • Phase2 - 127 participants
- • The objective of this randomized, surgically controlled, double-blinded, Phase 2 study is to evaluate the safety and efficacy of AAV2-GDNF delivered to the putamen in subjects with moderate Parkinson's Disease
Who can take part?
- • Ages 45 Years to 75 Years
- • Diagnosed with parkinson disease
Where?
- • Bristol - North Bristol NHS Trust - Southmead Hospital (Neurology)
- • Cardiff - University Hospital of Wales (Surgical)
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The objective of this randomized, surgically controlled, double-blinded, Phase 2 study is to evaluate the safety and efficacy of AAV2-GDNF delivered to the putamen in subjects with moderate Parkinson's Disease.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 45 Years - 75 Years
- Who can join: All genders
What the study is looking for
- ✓Male and female adults 45-75 years of age inclusive, at the time of signing of agreement to take part Type of Subject and...
- ✓Diagnosed with Parkinson's disease in the past 4-10 years (inclusive) as defined by the following:
- ✓Presence of bradykinesia PLUS any of the following:
- ✓Rigidity
- ✓Rest tremor
Who cannot take part
- ✗Known history or current evidence of medical, genetic, or neurological conditions that may provide an alternative to...
- ✗Presence or history of significant vascular and/or cardiovascular disease
- ✗Presence of significant cognitive impairment, poorly controlled depression/anxiety
- ✗Presence or history of psychosis or impulse control disorder
- ✗History of cancer other than treated cutaneous squamous or basal cell carcinomas
See the full criteria
Where Is This Study? (2 UK sites)
North Bristol NHS Trust - Southmead Hospital (Neurology)
Bristol, United Kingdom
University Hospital of Wales (Surgical)
Cardiff, United Kingdom
