Back to resultsStudy of Liatermin (r-metHuGDNF) Administered by Bilateral Intraputaminal (IPu) Infusion to Subjects With Idiopathic Parkinson's Disease
Primary Purpose
Idiopathic Parkinson's Disease
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Liatermin (r-metHuGDNF)
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Parkinson's Disease focused on measuring Bilateral, Idiopathic Parkinson's Disease
Eligibility Criteria
Inclusion Criteria: - Diagnosis of bilateral, idiopathic Parkinson's disease
Sites / Locations
Outcomes
Primary Outcome Measures
United Parkinson's Disease Rating Scale
Secondary Outcome Measures
Timed Motor Tests
Dyskinesia ratings
Diary ratings
Patient reported outcomes measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00115427
Brief Title
Study of Liatermin (r-metHuGDNF) Administered by Bilateral Intraputaminal (IPu) Infusion to Subjects With Idiopathic Parkinson's Disease
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 Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Amgen
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Parkinson's Disease
Keywords
Bilateral, Idiopathic Parkinson's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Liatermin (r-metHuGDNF)
Primary Outcome Measure Information:
Title
United Parkinson's Disease Rating Scale
Secondary Outcome Measure Information:
Title
Timed Motor Tests
Title
Dyskinesia ratings
Title
Diary ratings
Title
Patient reported outcomes measures
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Diagnosis of bilateral, idiopathic Parkinson's disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
URL
http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf
Description
Notice regarding posted summaries of trial results
URL
http://download.veritasmedicine.com/REGFILES/amgen/20020168.pdf
Description
To access clinical trial results information click on this link
Learn more about this trial
Study of Liatermin (r-metHuGDNF) Administered by Bilateral Intraputaminal (IPu) Infusion to Subjects With Idiopathic Parkinson's Disease
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