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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
127
Bilateral image-guided infusion of AAV2-GDNF into putamen, single dose
Bilateral partial burr/twist holes without dural penetration
Change from baseline to Month 18 on PD Motor Diary
Normalized Good ON time per Hauser Diary
Time frame: 18 months
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Mayo Clinic
Phoenix, Arizona, United States
NOT_YET_RECRUITINGUCI Alpha Clinic (Neurology)
Irvine, California, United States
RECRUITINGLoma Linda University (Neurology)
Loma Linda, California, United States
RECRUITINGLoma Linda University (Surgical)
Loma Linda, California, United States
ACTIVE_NOT_RECRUITINGUniversity of California San Francisco (Neurology)
San Francisco, California, United States
RECRUITINGUniversity of San Francisco (Surgical)
San Francisco, California, United States
ACTIVE_NOT_RECRUITINGCenExel Rocky Mountain Clinical Research (Neurology)
Englewood, Colorado, United States
RECRUITINGGeorgetown University (Neurology)
Washington D.C., District of Columbia, United States
RECRUITINGParkinson's Disease and Movement Disorders Center of Boca Raton (Neurology)
Boca Raton, Florida, United States
RECRUITINGUniversity of Florida
Gainesville, Florida, United States
NOT_YET_RECRUITING...and 36 more locations