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

This study has been completed.
Information provided by:
Amgen Identifier:
First received: September 6, 2005
Last updated: February 18, 2010
Last verified: February 2010
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.

Condition Intervention
Idiopathic Parkinson's Disease
Drug: Safety observation

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Multi-Center, Observational Safety Registry of Subjects With Idiopathic Parkinson's Disease Previously Treated With Intraputaminal Infusion of Liatermin

Resource links provided by NLM:

Further study details as provided by Amgen:

Primary Outcome Measures:
  • Adverse Events [ Time Frame: 24 months ]

Biospecimen Retention:   None Retained
none collected.

Enrollment: 31
Study Start Date: June 2005
Study Completion Date: September 2007
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Observational Group
Subjects previously administered GDNF and have discontinued the drug.
Drug: Safety observation
Subjects previously enrolled in a GDNF protocol observed for 2 years after discontinuation of drug.


Ages Eligible for Study:   35 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with idiopathic Parkinson's Disease
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00148369

Sponsors and Collaborators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Global Development Leader, Amgen Inc. Identifier: NCT00148369     History of Changes
Other Study ID Numbers: 20040256
Study First Received: September 6, 2005
Last Updated: February 18, 2010

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases processed this record on May 25, 2017