BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS)



Status:Active, not recruiting
Conditions:Neurology, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:19 - 58
Updated:8/9/2018
Start Date:February 2, 2009
End Date:September 28, 2020

Use our guide to learn which trials are right for you!

A Dose-Blind, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of Two Doses of BG00012 Monotherapy in Subjects With Relapsing-Remitting Multiple Sclerosis

The primary objective of this study is to evaluate the long-term safety profile of BG00012
(dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term
efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further
the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic
resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301
(NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on
health economics assessments and the visual function test.

The initial BG00012 dosage for the extension study (240 mg BID or 240 mg TID) was the same as
that used in the Phase 3 Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451).
Subsequent to the initiation of this study, BG00012 was approved in several countries for the
treatment of MS at a dose of 240 mg BID. For this reason, all participants continuing in this
study will receive the currently marketed dose of 240 mg BID.

Key Inclusion Criteria:

-Subjects who participated in and completed as per protocol previous BG00012 clinical
studies 109MS301 (NCT00420212) or 109MS302 (NCT00451451).

Key Exclusion Criteria:

- Any significant change in medical history from 109MS301 or 109MS302 that would have
excluded subject's participation from their previous study.

- Subjects from 109MS301 or 109MS302 who discontinued oral study treatment due to an AE
or due to reasons other than protocol-defined relapse/disability progression.

- Subjects from 109MS301 or 109MS302 who discontinued study treatment due to disability
progression or relapses and did not follow the modified visit schedule up to Week 96.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
50
sites
?
mi
from
Loma Linda, CA
Click here to add this to my saved trials
?
mi
from
Albany, NY
Click here to add this to my saved trials
?
mi
from
Amherst, NY
Click here to add this to my saved trials
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
?
mi
from
Bellevue, OH
Click here to add this to my saved trials
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
?
mi
from
Boston, MA
Click here to add this to my saved trials
?
mi
from
Boulder, CO
Click here to add this to my saved trials
?
mi
from
Buffalo, NY
Click here to add this to my saved trials
Charlotte, North Carolina 28207
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
?
mi
from
Chesterfield, MO
Click here to add this to my saved trials
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
?
mi
from
Cordova, TN
Click here to add this to my saved trials
?
mi
from
Dayton, OH
Click here to add this to my saved trials
?
mi
from
Evanston, IL
Click here to add this to my saved trials
Farmington Hills, Michigan 48334
?
mi
from
Farmington Hills, MI
Click here to add this to my saved trials
?
mi
from
Fort Collins, CO
Click here to add this to my saved trials
?
mi
from
Fort Wayne, IN
Click here to add this to my saved trials
?
mi
from
Hopedale, MA
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Huntsville, AL
Click here to add this to my saved trials
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
?
mi
from
Issaquah, WA
Click here to add this to my saved trials
?
mi
from
Kansas City, KS
Click here to add this to my saved trials
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
?
mi
from
Kogarah,
Click here to add this to my saved trials
?
mi
from
Madison, WI
Click here to add this to my saved trials
?
mi
from
Maitland, FL
Click here to add this to my saved trials
?
mi
from
Medford, OR
Click here to add this to my saved trials
?
mi
from
Mesa, AZ
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
?
mi
from
Naples, FL
Click here to add this to my saved trials
?
mi
from
Newport News, VA
Click here to add this to my saved trials
?
mi
from
North Haven, CT
Click here to add this to my saved trials
?
mi
from
Patchogue, NY
Click here to add this to my saved trials
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
?
mi
from
Portland, OR
Click here to add this to my saved trials
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
?
mi
from
Rumford, RI
Click here to add this to my saved trials
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
?
mi
from
Sarasota, FL
Click here to add this to my saved trials
?
mi
from
Shreveport, LA
Click here to add this to my saved trials
?
mi
from
Tampa, FL
Click here to add this to my saved trials
?
mi
from
Washington,
Click here to add this to my saved trials
?
mi
from
Wichita, KS
Click here to add this to my saved trials