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

Amgen

Status: Completed

Conditions: Idiopathic Parkinson's Disease

Treatments: Drug: Safety observation

Study type: Observational

Funder types: Industry

Identifiers

NCT00148369

20040256

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 35 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

31 participants in 1 patient group

Observational Group

Description:

Subjects previously administered GDNF and have discontinued the drug.

Treatment:

Drug: Safety observation