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NCT00111982 Clinical Trial

Trial of Extended Treatment With Liatermin (r-metHuGDNF) Administered by Continuous Intraputaminal (IPu)Infusion to Subjects With Idiopathic Parkinson's Disease Who Have Completed a Previous Trial of Liatermin

Parkinson's Disease Clinical Trial

Official title:
Multi-Center, Open-Label Trial of Extended Treatment With Liatermin (r-metHuGDNF) Administered by Continuous Intraputaminal (IPu) Infusion to Subjects With Idiopathic Parkinson's Disease Who Have Completed a Previous Trial of Liatermin (Protocol 20020168)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00111982
Other study ID # 20030160
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received May 27, 2005
Last updated February 25, 2010
Start date December 2003
Est. completion date February 2006

Study information
Verified date February 2010
Source Amgen
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine long-term efficacy of continuous IPu liatermin infusion administered with concomitant standard anti-Parkinsonian therapy.

Recruitment information / eligibility
Status Completed
Enrollment 34
Est. completion date February 2006
Est. primary completion date November 2005
Accepts healthy volunteers No
Gender Both
Age group 35 Years to 70 Years
Eligibility Inclusion Criteria: - Completion of the 20020168 protocol

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Biological:
• Liatermin
Liatermin

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Amgen Medtronic

Outcome
Type Measure Description Time frame Safety issue
Primary Percent change in UPDRS 24 months No
Secondary Incidence of treatment emergent and device related adverse events 24 months Yes
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