The objective of this Phase 2, open-label, single group, one-time, fixed-dose study is to assess the safety and efficacy of bilateral intraputaminal infusion of AB-1005 (AAV2-GDNF gene therapy) in Japanese patients with moderate Parkinson's Disease (PD).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Bilateral image-guided infusion of AAV2-GDNF into putamen, single dose
Nagoya Central Hospital - Neurosurgery
Nagoya, Aichi-ken, Japan
Nagoya University Hospital - Neurology
Nagoya, Aichi-ken, Japan
Yokohama City University Medical Center - Neurology
Yokohama, Kanagawa, Japan
National Hospital Organization Osaka Toneyama Medical Center - Neurology
Toyonaka, Osaka, Japan
Incidence of adverse events up to Month 18 after study intervention
Number and proportion of participants with at least one adverse event
Time frame: Up to 18 months
Change from Baseline to Month 18 in normalized Good ON time measured with PD Motor Diary
Time frame: Up to 18 months
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Juntendo University Hospital - Neurology
Bunkyo-ku, Tokyo, Japan
National Hospital Organization Utano National Hospital - Neurology
Kyoto, Japan