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:
Collaborator:
Medtronic
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00148369
First received: September 6, 2005
Last updated: February 18, 2010
Last verified: February 2010
  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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00148369

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

Additional Information:
No publications provided

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00148369     History of Changes
Other Study ID Numbers: 20040256
Study First Received: September 6, 2005
Last Updated: February 18, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on October 02, 2014