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NCT00115427 Clinical Trial

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

Idiopathic Parkinson's Disease Clinical Trial

Official title:
Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial of Liatermin (r-metHuGDNF) Administered by Bilateral Intraputaminal (IPu) Infusion to Subjects With Idiopathic Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00115427
Other study ID # 20020168
Secondary ID
Status Completed
Phase Phase 1
First received June 22, 2005
Last updated January 10, 2008
Start date March 2003

Study information
Verified date January 2008
Source Amgen
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 35 Years to 70 Years
Eligibility Inclusion Criteria: - Diagnosis of bilateral, idiopathic Parkinson's disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Liatermin (r-metHuGDNF)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Amgen

Outcome
Type Measure Description Time frame Safety issue
Primary United Parkinson's Disease Rating Scale
Secondary Timed Motor Tests
Secondary Dyskinesia ratings
Secondary Diary ratings
Secondary Patient reported outcomes measures
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Completed NCT02565628 - PF-06669571 In Subjects With Idiopathic Parkinson's Disease Phase 1
Completed NCT01617135 - Safety, Pharmacokinetics and Efficacy Study of CVT-301 Inpatients With Parkinson's Disease and "Off" Episodes Phase 2
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