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

Phase 1

Completed

• Conditions: Parkinson's Disease
• Interventions: Biological: Liatermin

• Registration Number: NCT00111982
• Lead Sponsor: Amgen

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-12
• Study First Submitted: 2005-05-27
• Study First Submitted QC: 2005-05-27
• Study First Posted: 2005-05-30
• Primary Completion: 2005-11
• Study Completion: 2006-02
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-25
• Last Update Posted: 2010-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• Completion of the 20020168 protocol

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Liatermin	Liatermin	Bilateral continuous infusion of liatermin for up to 24 months.

Primary Outcome Measures

Name	Time	Method
Percent change in UPDRS	24 months

Secondary Outcome Measures

Name	Time	Method
Incidence of treatment emergent and device related adverse events	24 months