Michigan State University | Department of Neurology
Status and phase
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About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Age
Male and female adults 45-75 years of age inclusive, at the time of signing of informed consent Type of Subject and Disease Characteristics
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:
Presence of motor fluctuations as measured by the PD Motor Diary
Stable anti-parkinsonian medication regiment for >/= 4 weeks prior to screening
Must demonstrate responsiveness to levodopa therapy
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
87 participants in 2 patient groups
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Central trial contact
Christian Urrea, MD; Nisha Chhabria, MD
Data sourced from clinicaltrials.gov
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