Actively Recruiting
A Study of AAV2-GDNF in Adults With Moderate Parkinson's Disease (REGENERATE-PD)
Led by AskBio Inc · Updated on 2025-12-08
127
Participants Needed
39
Research Sites
220 weeks
Total Duration
On this page
Sponsors
A
AskBio Inc
Lead Sponsor
B
Bayer
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
A Study of AAV2-GDNF in Adults With Moderate Parkinson's Disease (REGENERATE-PD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female adults 45-75 years of age inclusive, at the time of signing of informed consent
- Diagnosed with Parkinson's disease in the past 4-10 years inclusive
- Presence of bradykinesia plus one or more of rigidity, rest tremor, or postural instability
- Presence of motor fluctuations as measured by the PD Motor Diary
- Stable anti-parkinsonian medication regimen for 4 or more weeks prior to screening
- Must demonstrate responsiveness to levodopa therapy
You will not qualify if you...
- Known history or current evidence of medical, genetic, or neurological conditions that may provide an alternative to idiopathic PD diagnosis
- Presence or history of significant vascular and/or cardiovascular disease
- Presence of significant cognitive impairment, poorly controlled depression or anxiety
- Presence or history of psychosis or impulse control disorder
- History of malignancy other than treated cutaneous squamous or basal cell carcinomas
- Presence of clinically relevant conditions that could compromise surgical suitability and/or subject safety
- Contraindication to magnetic resonance imaging and/or use of gadolinium-based contrast agents
- Prior history of brain surgery including DBS, pallidotomy, focused ultrasound thalamotomy, or other experimental neurosurgical procedures
- Chronic immunosuppressive therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 39 locations
1
UCI Alpha Clinic (Neurology)
Irvine, California, United States, 92697
Actively Recruiting
2
Loma Linda University (Neurology)
Loma Linda, California, United States, 92354
Actively Recruiting
3
Loma Linda University (Surgical)
Loma Linda, California, United States, 92354
Active, Not Recruiting
4
University of California San Francisco (Neurology)
San Francisco, California, United States, 94143
Actively Recruiting
5
University of San Francisco (Surgical)
San Francisco, California, United States, 94143
Active, Not Recruiting
6
CenExel Rocky Mountain Clinical Research (Neurology)
Englewood, Colorado, United States, 80113
Actively Recruiting
7
Georgetown University (Neurology)
Washington D.C., District of Columbia, United States, 20057
Actively Recruiting
8
Parkinson's Disease and Movement Disorders Center of Boca Raton (Neurology)
Boca Raton, Florida, United States, 33486
Actively Recruiting
9
Parkinson's Disease Treatment Center of Southwest Florida (Neurology)
Port Charlotte, Florida, United States, 33980
Active, Not Recruiting
10
Emory University (Surgical)
Atlanta, Georgia, United States, 30322
Active, Not Recruiting
11
Rush University Medical Center (Neurology)
Chicago, Illinois, United States, 60612
Actively Recruiting
12
University of Kansas Medical Center (Neurology)
Kansas City, Kansas, United States, 66103
Actively Recruiting
13
Massachusetts General Hospital (Neurology)
Boston, Massachusetts, United States, 02114
Actively Recruiting
14
Massachusetts General Hospital (Surgical)
Boston, Massachusetts, United States, 02114
Active, Not Recruiting
15
Michigan State University (Neurology)
East Lansing, Michigan, United States, 48824
Actively Recruiting
16
Quest Research Institute (Neurology)
Farmington Hills, Michigan, United States, 48334
Actively Recruiting
17
Cleveland Clinic Lou Ruvo (Neurology)
Las Vegas, Nevada, United States, 89106
Actively Recruiting
18
University of North Carolina (Neurology)
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
19
Duke Neurosurgery (Surgical)
Durham, North Carolina, United States, 27705
Active, Not Recruiting
20
Duke University (Neurology)
Durham, North Carolina, United States, 27710
Actively Recruiting
21
Ohio State University (Surgical)
Columbus, Ohio, United States, 43210
Active, Not Recruiting
22
University of Pennsylvania (Neurology)
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
23
Vanderbilt University (Neurology)
Nashville, Tennessee, United States, 37232
Actively Recruiting
24
Houston Methodist (Neurology)
Houston, Texas, United States, 77030
Actively Recruiting
25
Houston Methodist (Surgical)
Houston, Texas, United States, 77030
Active, Not Recruiting
26
EvergreenHealth Research Department (Neurology)
Kirkland, Washington, United States, 98034
Actively Recruiting
27
University of Wisconsin (Neurology)
Madison, Wisconsin, United States, 53705
Actively Recruiting
28
Charité - Universitätsmedizin Berlin (Surgical)
Berlin, Germany
Active, Not Recruiting
29
Philipps-Universität Marburg (Neurology)
Marburg, Germany
Actively Recruiting
30
Universitätsklinikum Tübingen (Neurology)
Tübingen, Germany
Actively Recruiting
31
Universitätsklinikum Tübingen (Surgical)
Tübingen, Germany
Active, Not Recruiting
32
Universitätsklinikum Würzburg (Neurology)
Würzburg, Germany
Actively Recruiting
33
Copernicus Podmiot Leczniczy, Szpital św. Wojciecha (Neurology)
Gdansk, Poland
Actively Recruiting
34
Specjalistyczna Praktyka Lekarska Prof. Grzegorz Opala (Neurology)
Katowice, Poland
Actively Recruiting
35
Mazowiecki Szpital Bródnowski (Neurology)
Warsaw, Poland
Actively Recruiting
36
Mazowiecki Szpital Bródnowski (Surgical)
Warsaw, Poland
Active, Not Recruiting
37
Samodzielny Publiczny Szpital Kliniczny im. Prof. W. Orłowskiego CMKP (Neurology)
Warsaw, Poland
Actively Recruiting
38
North Bristol NHS Trust - Southmead Hospital (Neurology)
Bristol, United Kingdom
Actively Recruiting
39
University Hospital of Wales (Surgical)
Cardiff, United Kingdom
Active, Not Recruiting
Research Team
N
Nisha Chhabria, MD
CONTACT
A
Amber Van Laar, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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