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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

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ClinicalTrials.gov Identifier: NCT00111982
Recruitment Status : Completed
First Posted : May 30, 2005
Last Update Posted : February 26, 2010
Sponsor:
Collaborator:
Medtronic
Information provided by:
Amgen

Brief Summary:
The purpose of this study is to determine long-term efficacy of continuous IPu liatermin infusion administered with concomitant standard anti-Parkinsonian therapy.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Biological: Liatermin Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
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)
Study Start Date : December 2003
Actual Primary Completion Date : November 2005
Actual Study Completion Date : February 2006

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Liatermin
Bilateral continuous infusion of liatermin for up to 24 months.
Biological: Liatermin
Liatermin




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

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


Information from the National Library of Medicine

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

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

Additional Information:
Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00111982     History of Changes
Other Study ID Numbers: 20030160
First Posted: May 30, 2005    Key Record Dates
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