A Multi-Center, Observational Safety Registry of Subjects With Idiopathic Parkinson's Disease Previously Treated With Intraputaminal Infusion of Liatermin
February 18, 2010 updated by: Amgen
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
31
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Subjects with idiopathic Parkinson's Disease
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Observational Group
Subjects previously administered GDNF and have discontinued the drug.
|
Subjects previously enrolled in a GDNF protocol observed for 2 years after discontinuation of drug.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Adverse Events
Time Frame: 24 months
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2005
Primary Completion (Actual)
November 1, 2006
Study Completion (Actual)
September 1, 2007
Study Registration Dates
First Submitted
September 6, 2005
First Submitted That Met QC Criteria
September 6, 2005
First Posted (Estimate)
September 8, 2005
Study Record Updates
Last Update Posted (Estimate)
February 19, 2010
Last Update Submitted That Met QC Criteria
February 18, 2010
Last Verified
February 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20040256
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.