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

This study has been completed.

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00111982

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	Drug: Liatermin (r-metHuGDNF)	Phase I Phase II

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Liatermin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
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)

Further study details as provided by Amgen:

Primary Outcome Measures:

Percent change in UPDRS

Secondary Outcome Measures:

Incidence of treatment emergent and device related adverse events

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

Investigators

Study Director:

Amgen

More Information

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

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20030160
Study First Received:	May 27, 2005
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00111982
Health Authority:	United States: Food and Drug Administration

Keywords provided by Amgen:

bilateral, idiopathic Parkinson's Disease

Study placed in the following topic categories:

Ganglion Cysts
Movement Disorders
Parkinson Disease
Basal Ganglia Diseases

Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009