Long Term Follow-Up Study for rAAV-GAD Treated Subjects

Neurologix

Status: Terminated

Conditions: Parkinson's Disease

Treatments: Biological: rAAV-GAD

Study type: Observational

Funder types: Industry

Identifiers

NCT01301573

GAD-LTFU

Details and patient eligibility

About

The purpose of this observational study is the long term follow-up of Parkinson's patients who participated in a clinical trial in which they received AAV-GAD gene transfer into the subthalamic nucleus (STN) region of the brain. Patients will be followed once a year for up to five (5) years. The study will monitor and evaluate the long term effects of AAV-GAD and provide long term safety information.

Enrollment: 40 estimated patients

Sex: All

Ages: 30 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participated in a clinical trial where they received AAV-GAD
• Able to give informed consent to participate in the study

Exclusion criteria

• Received Deep Brain Stimulation after receiving AAV-GAD
• Received any experimental device in the brain after receiving AAV-GAD
• Had any type of brain surgery after receiving AAV-GAD
• Received any experimental therapy (drug or biologic) for Parkinson's disease or any other indication after receiving AAV-GAD

Trial design

40 participants in 1 patient group

rAAV-GAD Treated Subjects

Description:

rAAV-GAD treated subjects who are being observed for long-term effects of the gene therapy product which they received from participating in a previous clinical study.

Treatment:

Biological: rAAV-GAD