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

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ClinicalTrials.gov Identifier: NCT00115427
Recruitment Status : Completed
First Posted : June 23, 2005
Last Update Posted : January 11, 2008
Sponsor:
Information provided by:
Amgen

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.

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

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : March 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. United Parkinson's Disease Rating Scale

Secondary Outcome Measures :
  1. Timed Motor Tests
  2. Dyskinesia ratings
  3. Diary ratings
  4. Patient reported outcomes measures


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Inclusion Criteria: - Diagnosis of bilateral, idiopathic Parkinson's disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00115427


Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen

Additional Information:
Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00115427     History of Changes
Other Study ID Numbers: 20020168
First Posted: June 23, 2005    Key Record Dates
Last Update Posted: January 11, 2008
Last Verified: January 2008

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