Overview

A Multi-Center, Observational Safety Registry of Subjects With Idiopathic Parkinson's Disease Previously Treated With Intraputaminal Infusion of Liatermin

Status:
Completed
Trial end date:
2007-09-01
Target enrollment:
0
Participant gender:
All
Summary
The primary purpose of this study is to evaluate clinical and serologic outcomes after the discontinuation of liatermin therapy as assessed by development of new clinical conditions beyond those expected in patients with advancing Parkinson's disease. In addition, the development or resolution of anti-r-metHuGDNF binding and neutralizing antibodies will be monitored.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Amgen
Collaborator:
Medtronic
Criteria
Inclusion Criteria: - Subjects must have a diagnosis of bilateral, idiopathic Parkinson's
Disease who have been enrolled and treated with intraputaminal infusion of liatermin in a
previous Amgen/Medtronic-sponsored trial (protocols 20010109 or 20030160) or the Bristol
open-label study - At time of implant (Study 20030168), subjects need to have been 35 to 70
years of age