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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
History of Changes
  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:

U.S. FDA Resources

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:
AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site
Notice regarding posted summaries of trial results  This link exits the ClinicalTrials.gov site
To access clinical trial results information click on this link  This link exits the ClinicalTrials.gov site

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 June 17, 2013