Clinical trial NCT02430532: BG00012 and Delay of Disability Progression in Secondary Progressive Multiple Sclerosis
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Delaying Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Multiple Sclerosis, Secondary Progressive
Keywords: INSPIRE
SPMS
Tecfidera
BG00012
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2015-04-30
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 58
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to investigate whether treatment with BG00012 (dimethyl fumarate) compared with placebo slows the accumulation of disability not related to relapses in participants with secondary progressive multiple sclerosis (SPMS). The secondary objective of the study is to assess the effect of BG00012 compared with placebo on patient-reported outcomes, brain atrophy, and cognitive function.


Eligibility criteria: Key Inclusion Criteria:

* Onset of SPMS at least 1 to 2 years prior to randomization. SPMS is defined as relapsing-remitting disease followed by progression of disability independent of or not explained by relapses.
* Have documented confirmed evidence of disease progression independent of clinical relapses over the 1 year prior to randomization.
* Have an Expanded Disability Status Scale score of 3.0 to 6.5, inclusive.
* Have a Multiple Sclerosis (MS) Severity Score of 4 or higher.

Key Exclusion Criteria:

* Have a diagnosis of relapsing remitting multiple sclerosis or primary progressive MS as defined by the revised McDonald criteria.
* Had a recent clinical relapse (within 3 months) prior to randomization.
* Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; serious or acute liver, kidney, or bone marrow dysfunction; uncontrolled diabetes; serious or acute psychiatric illness that would limit compliance with study requirements.

Note: Other protocol-defined Inclusion/Exclusion criteria may apply

Primary outcomes:
measure: Time to Disability Progression Independent of Relapse
timeFrame: Up to 108 weeks
Secondary outcomes:
measure: Change From Baseline to 2 Years on the 12-Item Multiple Sclerosis Walking Scale (MSWS-12)
timeFrame: Baseline, 2 years
measure: Change From Baseline to Week 108 in ABILHAND Questionnaire Score
timeFrame: Baseline, Week 108
measure: Percentage Change From Baseline to Week 108 in Whole Brain Volume
timeFrame: Baseline, Week 108
measure: Change From Baseline to Week 108 in Cognitive Function as Measured by the Symbol Digit Modalities Test (SDMT)
timeFrame: Baseline, Week 108
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Research Site
state: California
city: San Francisco
country: United States
facility: Research Site
state: California
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Vero Beach
country: United States
facility: Research Site
state: Florida
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: Willow Grove
country: United States
facility: Research Site
state: Pennsylvania
city: Round Rock
country: United States
facility: Research Site
state: Texas
city: Bruxelles
country: Belgium
facility: Research Site
city: Brno
country: Czech Republic
facility: Research Site
city: Hradec Kralove
country: Czech Republic
facility: Research Site
city: Sittard-Geleen
country: Netherlands
facility: Research Site
city: Gdansk
country: Poland
facility: Research Site
city: Katowice
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Plewiska
country: Poland
facility: Research Site
city: Poznan
country: Poland
facility: Research Site
city: Banska Bystrica
country: Slovakia
facility: Research Site
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: