SAFETY STUDY OF AAV2-GDNF IN MSA

UCI Specialty Area: Neurology

Principal Investigator: Nicolas Phielipp

Official Title: RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED SAFETY STUDY OF GLIAL CELL LINE-DERIVED NEUROTROPHIC FACTOR GENE TRANSFER (AAV2-GDNF) IN MULTIPLE SYSTEM ATROPHY

A Study On:

Mulitple System Atrophy (MSA)

Study Description

Eligibility

Male and female adults 35-75 years of age (inclusive)
Diagnosed with MSA with sporadic, adult-onset (>30 yo) with predominant parkinsonian symptoms
Less than 4 years from clinical diagnosis of MSA with expected survival > 3 years
Stable medication regimen
Ability to walk with or without an assistive device

Presence of idiopathic Parkinson's disease or other neurological diseases
Myocardial sympathetic denervation inconsistent with an MSA diagnosis
Presence of dementia, psychosis, substance abuse or poorly controlled depression
Prior brain surgery (i.e. deep brain stimulator) or other brain imaging abnormalities
Receiving an investigational drug
History of cancer or poorly controlled medical conditions that would increase surgical risk
Inability to tolerate laying flat in an MRI or allergy to gadolinium

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

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You are eligible to participate in this study if you may be interested in participating in a research trial at UCI Health

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Future Research Use
Researchers will use your information to conduct this study. Once the study is done using your information, we may share them with other researchers so they can use them for other studies in the future. We will not share your name or any other private identifiable information that would let the researchers know who you are. We will not ask you for additional permission to share this de-identified information

Data Retention - In accordance with UC Office of the President policy, information will be retained for 10 years after the end of the calendar year in which the research is completed.

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