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

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00115427
First received: June 22, 2005
Last updated: January 10, 2008
Last verified: January 2008
  Purpose

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.


Condition Intervention Phase
Idiopathic Parkinson's Disease
Drug: Liatermin (r-metHuGDNF)
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • United Parkinson's Disease Rating Scale

Secondary Outcome Measures:
  • Timed Motor Tests
  • Dyskinesia ratings
  • Diary ratings
  • Patient reported outcomes measures

Study Start Date: March 2003
  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00115427

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00115427     History of Changes
Other Study ID Numbers: 20020168
Study First Received: June 22, 2005
Last Updated: January 10, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Bilateral, Idiopathic Parkinson's Disease

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on April 17, 2014