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NCT00148369 Clinical Trial

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

Idiopathic Parkinson's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00148369
Other study ID # 20040256
Secondary ID
Status Completed
Phase N/A
First received September 6, 2005
Last updated February 18, 2010
Start date June 2005
Est. completion date September 2007

Study information
Verified date February 2010
Source Amgen
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 31
Est. completion date September 2007
Est. primary completion date November 2006
Accepts healthy volunteers No
Gender Both
Age group 35 Years to 70 Years
Eligibility 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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Safety observation
Subjects previously enrolled in a GDNF protocol observed for 2 years after discontinuation of drug.

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Amgen Medtronic

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse Events 24 months Yes
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