Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00115427
Status:
COMPLETED
Last Update Posted:
2008-01-11
First Post:
2005-06-22
Brief Title:
Study of Liatermin r-metHuGDNF Administered by Bilateral Intraputaminal IPu Infusion to Subjects With Idiopathic Parkinsons Disease
Sponsor:
Amgen
Organization:
Amgen
Study Overview
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 Parkinsons Disease
Status:
COMPLETED
Status Verified Date:
2008-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This randomized study was designed to evaluate the efficacy and safety of IPu-infused liatermin 15mgputamenday compared with placebo in subjects with symptomatic levodopa-response Parkinsons 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None