GDNF Gene Therapy for Parkinson's Disease
About the study
The objective of this Phase 1b investigation is to evaluate the safety and potential clinical effect of AAV2-GDNF delivered to the putamen in subjects with either a recent or a long-standing diagnosis of PD.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Key Inclusion Criteria:
- Male and female adults 35-75 years of age (inclusive)
- Diagnosed with Parkinson's disease
- Modified Hoehn and Yahr stage I-III OFF medication
Time since receiving a clinical diagnosis of PD and disease severity consistent with one of the following:
- EITHER: Less than 5 years since clinical diagnosis of PD and mild to moderate UPDRS III OFF score
- OR: At least 4 years since clinical diagnosis of PD and moderate to severe UPDRS III OFF score
- Responsiveness to levodopa
EXCLUSION CRITERIA
Key Exclusion Criteria:
- Atypical parkinsonism
- Severe dyskinesia
- Presence of dementia, psychosis, substance abuse or qualify as "severe depression"
- Prior brain surgery (i.e. deep brain stimulator or DBS implantation) or other brain imaging abnormalities
- Receiving an investigational drug
- History of cancer or poorly controlled medical conditions that would increase surgical risk
- Inability to tolerate laying flat in an MRI or allergy to gadolinium
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Parkinson's Disease
Age (in years)
35 - 75
Phase
Phase 1
Participants needed
11
Est. Completion Date
Jun 30, 2027
Treatment type
Interventional
Sponsor
Brain Neurotherapy Bio, Inc.
ClinicalTrials.gov identifier
NCT04167540
Study number
GDNF-102
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