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Trial of Extended Treatment With Liatermin (r-metHuGDNF) Administered by Continuous Intraputaminal (IPu)Infusion to Subjects With Idiopathic Parkinson's Disease Who Have Completed a Previous Trial of Liatermin

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00111982
First Posted: May 30, 2005
Last Update Posted: February 26, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medtronic
Information provided by:
Amgen
  Purpose
The purpose of this study is to determine long-term efficacy of continuous IPu liatermin infusion administered with concomitant standard anti-Parkinsonian therapy.

Condition Intervention Phase
Parkinson's Disease Biological: Liatermin Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-Center, Open-Label Trial of Extended Treatment With Liatermin (r-metHuGDNF) Administered by Continuous Intraputaminal (IPu) Infusion to Subjects With Idiopathic Parkinson's Disease Who Have Completed a Previous Trial of Liatermin (Protocol 20020168)

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Percent change in UPDRS [ Time Frame: 24 months ]

Secondary Outcome Measures:
  • Incidence of treatment emergent and device related adverse events [ Time Frame: 24 months ]

Enrollment: 34
Study Start Date: December 2003
Study Completion Date: February 2006
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Liatermin
Bilateral continuous infusion of liatermin for up to 24 months.
Biological: Liatermin
Liatermin

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   35 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Inclusion Criteria: - Completion of the 20020168 protocol
  Contacts and Locations
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): NCT00111982


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

Additional Information:
Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00111982     History of Changes
Other Study ID Numbers: 20030160
First Submitted: May 27, 2005
First Posted: May 30, 2005
Last Update Posted: February 26, 2010
Last Verified: February 2010

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