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Study Complete
Sponsor ID
20040256

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

Sponsor ID
20040256
Clinicaltrials.gov ID
NCT00148369
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
N/A
Product
GDNF
Type
Observational
Masking
N/A
Enrollment
31
Additional Study Details

Protocol Summary

Primary Outcome Measures

Adverse Events

Timeframe: 24 months

Secondary Outcome Measures
Not Available

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

No locations found.
Study Info
Age
35 - 70 Years
Condition
  • Parkinson's Disease
    • Sex
    All
    Trial Dates
    Aug 2005 - Nov 2006
    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