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

Amgen31 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Idiopathic Parkinson's Disease

Interventions

Safety observationDRUG

Subjects previously enrolled in a GDNF protocol observed for 2 years after discontinuation of drug.

Eligibility

Sex: ALLMin age: 35 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Adverse Events

Time frame: 24 months

Data from ClinicalTrials.gov

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