North America, Europe, and rest of worldThe primary objective of this study is to determine whether BG00012, when compared with placebo, is effective in reducing the proportion of relapsing subjects at 2 years.The secondary objectives of this study…
ID
Source
Brief title
Condition
- Central nervous system infections and inflammations
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary analysis will be a Cox proportional hazards model for time to first
relapse. The proportion of subjects relapsed at 2 years will be estimated from
the Kaplan-Meier survival curve distribution.
Secondary outcome
Annualized relapse rate at 1 year will be analyzed using Poisson regression.
Disability progression as measured by EDSS will be
analyzed using a Cox proportional hazards model.
The number of new or newly enlarging T2 hyperintense lesions and Gd-enhancing
lesions will be analyzed using multiple logit regression.
Background summary
A Phase 2, double-blind, placebo-controlled, dose-finding, safety and efficacy
study in 257 subjects with relapsing-remitting multiple sclerosis (RRMS) (Study
C 1900) demonstrated that BG00012 (dimethyl fumarate [DMF]) significantly
reduced Gd enhancing on brain magnetic resonance imaging (MRI) after 6 months.
The drug was well tolerated at the three doses that were tested. The
combination of a potential immunomodulatory effect of DMF with its safety and
efficacy profile from the Phase 2 RRMS study support further study of its
clinical efficacy in the management of RRMS.
Study objective
North America, Europe, and rest of world
The primary objective of this study is to determine whether BG00012, when
compared with placebo, is effective in reducing the proportion of relapsing
subjects at 2 years.
The secondary objectives of this study are:
1. To determine whether BG00012, when compared with
placebo, is effective in:
* reducing the total number of new or newly enlarging T2 hyperintense lesions
on brain MRI scans in a subset of subjects at 2 years;
* reducing the total number of Gd-enhancing lesions on 3 brain MRI scans taken
over 2 years in a subset of subjects;
* reducing the rate of clinical relapses at 1 year;
* slowing the progression of disability at 2 years as measured by at least a
1.0 point increase on the EDSS from baseline EDSS >=1.0 that is sustained for
12 weeks, or at least a 1.5 point increase on the EDSS from baseline EDSS = 0
that is sustained for 12 weeks.
Study design
Multicenter, parallel-group, randomized, placebo-controlled, double-blind,
dose-comparison study
Intervention
-group 1
337 subjects will receive BG00012, 240mg BID (2 capsules/120mg twice a day) and
2 placebo capsules once a day
-group 2
337 subjects will receive BG00012, 240mg TID (2 capsules/120mg each 3 times a
day)
-group 3
337 subjects will receive placebo 2 capsules 3 times daily
Study burden and risks
The most commonly observed events were flushing, PS relapse, nasopharyngitis,
headache, nausea, diarrhea, fatigue, pruritis, upper abdominal pain, influenza,
and hot flush.
Thames House, Foundation Park
Maidenhead SL6 3UD
GB
Thames House, Foundation Park
Maidenhead SL6 3UD
GB
Listed location countries
Age
Inclusion criteria
-written informed consent
-aged 18 to 55 years old
-confirmed diagnosis of relapsing-remitting multiple sclerosis
-baseline EDDS between 0.0 and 5.0 inclusive (expanded disability status scale)
-must have experienced at least 1 relapse within the 12 months prior to randomization
Exclusion criteria
-primary progressive, secondary progressive, or progressive elapsing MS
-unable to perform the Timed 25-Foot Walk, Nine-Hole Peg Test (9HTP) with both upper extremities, and PASAT 3
-unable to perform visual function tests
-history of malignancy
-history of severe allergic of anaphylactic reactions or known drug hypersensitivity
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2006-003696-12-NL |
| CCMO | NL16020.096.07 |