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

Amgen

Status and phase: Completed; Phase 1

Conditions: Idiopathic Parkinson's Disease

Treatments: Drug: Liatermin (r-metHuGDNF)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00115427

20020168

Details and patient eligibility

About

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.

Sex: All

Ages: 35 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: - Diagnosis of bilateral, idiopathic Parkinson's disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind