VY-AADC02 for Parkinson's Disease With Motor Fluctuations



Status:Recruiting
Conditions:Parkinsons Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:40 - 75
Updated:3/29/2019
Start Date:June 28, 2018
End Date:December 2020
Contact:Kenneth J Adams, B.S.
Email:clinicaltrials@vygr.com
Phone:(857) 856-4148

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A Randomized, Placebo Surgery Controlled, Double-blinded, Multi-center, Phase 2 Clinical Trial, Evaluating the Efficacy and Safety of VY-AADC02 in Advanced Parkinson's Disease With Motor Fluctuations

The objectives of this study are to assess the distribution, efficacy, and safety of
VY-AADC02 in Patients with Parkinson's Disease with Motor Fluctuations.


Key Inclusion Criteria:

1. Males and females, 40 to 75 years of age (inclusive).

2. Diagnosis of PD, consistent with United Kingdom Brain Bank Criteria.

3. Unequivocal responsiveness to dopaminergic therapy, as judged by the Investigator.

4. Disease duration from diagnosis of ≥4 years.

5. In the judgment of the Investigator, a stable, optimal regimen of Parkinson's
medications for at least 4 weeks prior to screening evaluation.

6. Stable cognitive and psychological function based on screening evaluations.

7. In the judgment of the Investigator, stable Parkinson's features and symptoms for at
least 4 weeks prior to screening evaluation.

8. Agrees to defer any neurological surgery, including deep brain stimulation, other
invasive treatments for PD including duodopa, or the addition of new dopaminergic
formulations until after completing the 12-month study visit.

9. Ability to travel to study visits.

Key Exclusion Criteria:

1. Atypical or secondary parkinsonism, including but not limited to symptoms believed to
be due to trauma, brain tumor, infection, cerebrovascular disease, other neurological
disease, or to drugs, chemicals, or toxins, as determined by the Investigator.

2. MoCA score <26.

3. Use of tetrahydrocannabinol within 6 months of screening evaluation.

4. Brain imaging abnormalities in the striatum or other regions that would substantially
increase risk of surgery.

5. Contraindication to MRI and/or gadolinium-based contrast agents.

6. Prior brain surgery or infusion therapies that could complicate the study procedure or
negatively impact study evaluations as determined from participant interview,
screening MRI, or medical records.

7. History of malignancy other than treated carcinoma in situ within 3 years of screening
evaluation.

8. Prior gene transfer, current treatment with any investigational agent (drug or device)
within 2 months of screening evaluation, or participation or plans to participate in
another research study.

9. Ongoing treatments or planned treatments that might interfere with interpretation of
the study outcome including deep brain stimulation.
We found this trial at
13
sites
3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
Phone: 913-588-0013
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Phone: 404-712-7013
Emory University Hospital As the largest health care system in Georgia and the only health...
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Atlanta, GA
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Aurora, Colorado 80045
Principal Investigator: Steven Ojemann, MD
Phone: 303-724-6247
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Chicago, Illinois 60611
Principal Investigator: Cindy Zadikoff, MD
Phone: 312-503-1819
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Chicago, IL
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Columbus, Ohio
Phone: 614-688-6685
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East Lansing, Michigan 48823
Principal Investigator: John Goudreau, DO, PhD
Phone: 517-884-2274
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Principal Investigator: Naomi Lubarr
Phone: 551-996-3075
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Irvine, California 92868
Principal Investigator: Neal Hermanowicz, MD
Phone: 949-824-1114
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Irvine, CA
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New York, New York 10016
Principal Investigator: Andrew Feigin, MD
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New York, NY
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111 S 11th St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: Daniel Kremens, MD
Phone: 215-955-2606
Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
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Pittsburgh, Pennsylvania 15213
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San Francisco, California 94121
Principal Investigator: Paul Larson, MD
Phone: 415-353-9666
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San Francisco, California 94143
Principal Investigator: Chad Christine, MD
Phone: 415-353-9666
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