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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:
Collaborator:
Medtronic
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00111982
First received: May 27, 2005
Last updated: February 25, 2010
Last verified: February 2010
History of Changes
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:
  • Percent change in UPDRS [ Time Frame: 24 months ] [ Designated as safety issue: No ]

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

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

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

Inclusion Criteria: - Completion of the 20020168 protocol

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00111982

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

Additional Information:
AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00111982     History of Changes
Other Study ID Numbers: 20030160
Study First Received: May 27, 2005
Last Updated: February 25, 2010
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