Summary

Eligibility
for people ages 35-75 (full criteria)
Location
at Irvine, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Nicolas Phielipp, MD

Description

Summary

The objective of this Phase 1b investigation is to evaluate the safety and potential clinical effect of AAV2-GDNF delivered to the putamen in subjects with either a recent or a long-standing diagnosis of PD.

Official Title

Open-Label Safety Study of Glial Cell Line-Derived Neurotrophic Factor Gene Transfer (AAV2- GDNF) in Parkinson's Disease

Keywords

Parkinson's Disease PD Neurotrophic factor Growth factor Glial cell line-derived neurotrophic factor GDNF AAV Gene therapy Parkinson Disease AAV2-GDNF

Eligibility

You can join if…

Open to people ages 35-75

  • Male and female adults 35-75 years of age (inclusive)
  • Diagnosed with Parkinson's disease
  • Modified Hoehn and Yahr stage I-III OFF medication
  • Time since receiving a clinical diagnosis of PD and disease severity consistent with one of the following:
  • EITHER: Less than 5 years since clinical diagnosis of PD and mild to moderate UPDRS III OFF score
  • OR: At least 4 years since clinical diagnosis of PD and moderate to severe UPDRS III OFF score
  • Responsiveness to levodopa

You CAN'T join if...

  • Atypical parkinsonism
  • Severe dyskinesia
  • Presence of dementia, psychosis, substance abuse or qualify as "severe depression"
  • Prior brain surgery (i.e. deep brain stimulator or DBS implantation) 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

Locations

  • University of California Irvine accepting new patients
    Irvine California 92697 United States
  • University of California San Francisco accepting new patients
    San Francisco California 94103 United States

Lead Scientist at UC Irvine

  • Nicolas Phielipp, MD
    Associate Clinical Professor, Neurology. Authored (or co-authored) 9 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Brain Neurotherapy Bio, Inc.
ID
NCT04167540
Phase
Phase 1
Study Type
Interventional
Last Updated