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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00115427
Enrollment
Unknown
Registered
2005-06-23
Start date
2003-03-31
Completion date
Unknown
Last updated
2008-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Parkinson's Disease

Keywords

Bilateral, Idiopathic Parkinson's Disease

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.

Interventions

DRUGLiatermin (r-metHuGDNF)

Sponsors

Amgen
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

- Diagnosis of bilateral, idiopathic Parkinson's disease

Design outcomes

Primary

MeasureTime frame
United Parkinson's Disease Rating Scale

Secondary

MeasureTime frame
Timed Motor Tests
Dyskinesia ratings
Diary ratings
Patient reported outcomes measures

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026