Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
11 participants
INTERVENTIONAL
2020-04-01
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Earlier stage PD
AAV2-GDNF
Bilateral image-guided infusion of AAV2-GDNF into putamen, single dose
Later stage PD
AAV2-GDNF
Bilateral image-guided infusion of AAV2-GDNF into putamen, single dose
Interventions
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AAV2-GDNF
Bilateral image-guided infusion of AAV2-GDNF into putamen, single dose
Eligibility Criteria
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Inclusion Criteria
* 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:
1. EITHER: Less than 5 years since clinical diagnosis of PD and mild to moderate UPDRS III OFF score
2. OR: At least 4 years since clinical diagnosis of PD and moderate to severe UPDRS III OFF score
* Responsiveness to levodopa
Exclusion Criteria
* 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
35 Years
75 Years
ALL
No
Sponsors
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AskBio Inc
INDUSTRY
California Institute for Regenerative Medicine (CIRM)
OTHER
Brain Neurotherapy Bio, Inc.
INDUSTRY
Responsible Party
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Locations
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University of California Irvine
Irvine, California, United States
University of California San Francisco
San Francisco, California, United States
The Ohio State University Medical Center
Columbus, Ohio, United States
Countries
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Other Identifiers
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GDNF-102
Identifier Type: -
Identifier Source: org_study_id
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