Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00451451
Status:
COMPLETED
Last Update Posted:
2015-01-26
First Post:
2007-03-21
Brief Title:
Efficacy and Safety Study of Oral BG00012 With Active Reference in Relapsing-Remitting Multiple Sclerosis
Sponsor:
Biogen
Organization:
Biogen
Study Overview
Official Title:
A Randomized Multicenter Placebo-Controlled and Active Reference Glatiramer Acetate Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis
Status:
COMPLETED
Status Verified Date:
2015-01
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:
CONFIRM
Brief Summary:
To determine if treatment with BG00012 can decrease the number of MS relapses during a certain time period Other goals of the study are to determine if over time BG00012 treatment can decrease the number of certain types of brain lesions commonly seen in MS patients and slow down the time it takes for MS to get worse
Other objectives of the study are to determine the safety and tolerability of BG00012 as well as the effect it may have on tests and evaluations used to assess MS Additionally glatiramer acetate is being used to compare its benefits and risks with placebo and BG00012
Other objectives of the study are to determine the safety and tolerability of BG00012 as well as the effect it may have on tests and evaluations used to assess MS Additionally glatiramer acetate is being used to compare its benefits and risks with placebo and BG00012
Detailed Description:
Multiple sclerosis MS is a chronic disease of the central nervous system that affects approximately 400000 persons in North America and 365000 persons in Europe It is predominantly a disease of young adults primarily women with disease onset typically occurring between the ages of 20 and 40
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