Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00337779
Status:
COMPLETED
Last Update Posted:
2011-10-10
First Post:
2006-06-14
Brief Title:
Clinical Trial Comparing Treatment of Relapsing-Remitting Multiple Sclerosis RR-MS With Two Doses of Glatiramer Acetate GA
Sponsor:
Teva Branded Pharmaceutical Products RD Inc
Organization:
Teva Branded Pharmaceutical Products RD Inc
Study Overview
Official Title:
A Multinational Multicenter Randomized Parallel-Group Double-Blind Study to Compare the Efficacy Tolerability and Safety of Glatiramer Acetate Injection 40 mgml to That of Glatiramer Acetate Injection 20 mgml Administered Once Daily by Subcutaneous Injection in Subjects With Relapsing Remitting R-R Multiple Sclerosis MS
Status:
COMPLETED
Status Verified Date:
2011-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Teva is developing a 40 mgml GA Injection administered once daily under the skin for the treatment of R-R MS The study drug is a higher dose formulation of Copaxone 20 mgml GA a marketed medication approved for the treatment of R-R MS GA is an immunomodulating drug that has anti inflammatory and neuroprotective properties The study treatment duration is 12 months
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