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

Amgen0 sites31 target enrollmentJune 2005

ConditionsIdiopathic Parkinson's Disease

InterventionsSafety observation

DrugsSafety observation

Overview

Phase: Not Applicable
Intervention: Safety observation
Conditions: Idiopathic Parkinson's Disease
Sponsor: Amgen
Enrollment: 31
Primary Endpoint: Adverse Events
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

June 2005

End Date

September 2007

Last Updated

16 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Amgen

Eligibility 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