Study of Liatermin (r-metHuGDNF) Administered by Bilateral Intraputaminal (IPu) Infusion to Subjects With Idiopathic Parkinson's Disease

Phase 1

Completed

• Conditions: Idiopathic Parkinson's Disease

• Registration Number: NCT00115427
• Lead Sponsor: Amgen

Brief Summary

This randomized study was designed to evaluate the efficacy and safety of IPu-infused liatermin (15mg/putamen/day) compared with placebo in subjects with symptomatic, levodopa-response Parkinson's disease. This study consisted of a 90-day evaluation period followed by implantation of the IPu delivery system and then a 6-month double-blind treatment period.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-03
• Study First Submitted: 2005-06-22
• Study First Submitted QC: 2005-06-22
• Study First Posted: 2005-06-23
• Status Verified: 2008-01
• Last Update Submitted: 2008-01-10
• Last Update Posted: 2008-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Diagnosis of bilateral, idiopathic Parkinson's disease

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
United Parkinson's Disease Rating Scale

Secondary Outcome Measures

Name	Time	Method
Timed Motor Tests
Dyskinesia ratings
Diary ratings
Patient reported outcomes measures