Randomized Double-Blind Placebo-controlled Safety Study of Glial Cell Line-Derived Neurotrophic Factor Gene Transfer (AAV2-GDNF) in Multiple System Atrophy
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
-
Conditions: Multiple System Atrophy
-
Age: Between 35 Year(s) - 75 Year(s)
-
Gender: Male or Female
-
Other Inclusion Criteria:
- Clinical diagnosis of MSA with clinical features of primarily Parkinsonism (MSA-P).
- Parkinsonian diagnosis ≤ 5 years at the time of screening.
- Ability to walk a distance of 25 feet (ft) with or without an assistive device.
You may not be eligible for this study if the following are true:
-
- Movement disorder due to known cerebrovascular disease, brain tumor, trauma, exposure to parkinsonian-linked toxicants or other neurological diseases.
- Presence of any Parkinson's disease (PD)-related mutation.
- Presence of dementia.
- Presence or history of psychosis.
- Presence of substance (i.e., drug, alcohol) abuse.
- History of stroke or poorly controlled cardiovascular disease.
- Uncontrolled hypertension or diabetes.
- History of malignancy (cerebral or systemic) other than treated cutaneous squamous or basal cell carcinomas.
- Clinically active infection.
- Prior brain surgery (i.e., deep brain stimulator implantation) or neuromodulatory intervention.
- Contraindication to MRI and/or use of gadolinium
- Pregnancy or lactation.
- Male or female with reproductive capacity that is unwilling to use barrier contraception for 3 months post-dosing.
- Chronic immunosuppressive therapy (e.g., chronic steroids, tumor necrosis factor (TNF) antagonists, chemotherapy).
- Unwilling to defer any vaccination within 1 month before or after treatment.
- Received investigational agent within 12 weeks prior to screening.
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.