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CompletedNCT00148369Updated Feb 19, 2010

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

An observational study in Idiopathic Parkinson's Disease, sponsored by Amgen. Completed. Open to participants aged 35 Years to 70 Years. Per ClinicalTrials.gov, last updated 2010-02-19.

Sponsored by Amgen · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
31
Ages
35 Years to 70 Years
Sex
All
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Study summary

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.

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Conditions studied

  • Idiopathic Parkinson's Disease

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In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's enrollment of 31 is below the median of 96 across 1,057 observational studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.

Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
35 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Subjects with idiopathic Parkinson's Disease

Eligibility 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

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Study design

Time perspective
Prospective
Enrollment
31 participants (actual)
Biospecimen retention
None retained

Groups and cohorts

  • Observational Group

    Subjects previously administered GDNF and have discontinued the drug.

    Drug: Safety observation

Interventions

  • DrugSafety observation

    Subjects previously enrolled in a GDNF protocol observed for 2 years after discontinuation of drug.

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What researchers measure

Primary outcomes

  1. Adverse Events

    Time frame: 24 months

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Study locations

No study locations are listed for this record.

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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 19, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00148369
Lead sponsor
Amgen
Collaborators
Medtronic
First posted
Sep 8, 2005
Start date
Jun 2005
Primary completion
Nov 2006
Completion
Sep 2007
Last update
Feb 19, 2010

Study contacts

MD
study director · Amgen
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2010. You cannot join it, but the record below documents what was studied.

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