A Phase 2, Randomized, Double-blind, Sham Surgery-controlled Study of the Efficacy and Safety of Intraputaminal AAV2-GDNF in the Treatment of Adults With Moderate Stage Parkinson's Disease
AskBio Inc
Summary
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.
Eligibility
- Age range
- 45–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Age 1. Male and female adults 45-75 years of age inclusive, at the time of signing of informed consent Type of Subject and Disease Characteristics 2. Diagnosed with Parkinson's disease in the past 4-10 years (inclusive) as defined by the following: 1. Presence of bradykinesia PLUS any of the following: * Rigidity * Rest tremor * Postural instability 2. Presence of motor fluctuations as measured by the PD Motor Diary 3. Stable anti-parkinsonian medication regimen for \>/= 4 weeks prior to screening 4. Must demonstrate responsiveness to levod…
Interventions
- DrugAAV2-GDNF gene therapy
Bilateral image-guided infusion of AAV2-GDNF into putamen, single dose
- Procedurecontrol surgery
Bilateral partial burr/twist holes without dural penetration
Locations (39)
- UCI Alpha Clinic (Neurology)Irvine, California
- Loma Linda University (Neurology)Loma Linda, California
- Loma Linda University (Surgical)Loma Linda, California
- University of California San Francisco (Neurology)San Francisco, California
- University of San Francisco (Surgical)San Francisco, California
- CenExel Rocky Mountain Clinical Research (Neurology)Englewood, Colorado