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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00148369
First Posted: September 8, 2005
Last Update Posted: February 19, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medtronic
Information provided by:
Amgen
  Purpose
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00148369


Sponsors and Collaborators
Amgen
Medtronic
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00148369     History of Changes
Other Study ID Numbers: 20040256
First Submitted: September 6, 2005
First Posted: September 8, 2005
Last Update Posted: February 19, 2010
Last Verified: February 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


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