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INSPIRE

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
Stopped earlyPhase 3Relapsing and progressiveNCT024305322014-003021-18

What it found

Stopped early

The trial ended early for another reason (see below).

Reason given: Sponsor Decision

What was tested

Treatment tested

Placebo or sham

  • Placebo

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Placebo300 (0.0%)
Tecfidera 240 mg BID285 (17.9%)

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Time to Disability Progression Independent of Relapse

    Up to 108 weeks

    Disability progressionRelapsesWalking and mobilityArm and hand function

  • The primary endpoint is time to disability progression independent of relapse, where progressors are defined as subjects who meet at least 1 of the following criteria confirmed at a second visit ≥6 months later and at Week 108 (or at the last available study visit for subjects who withdraw from the study early):

    Disability progressionRelapses

Other measures (4)

  • Change From Baseline to 2 Years on the 12-Item Multiple Sclerosis Walking Scale (MSWS-12)

    Baseline, 2 years

    Walking and mobility

  • Change From Baseline to Week 108 in ABILHAND Questionnaire Score

    Baseline, Week 108

  • Percentage Change From Baseline to Week 108 in Whole Brain Volume

    Baseline, Week 108

    MRI lesionsBrain volume loss

  • Change From Baseline to Week 108 in Cognitive Function as Measured by the Symbol Digit Modalities Test (SDMT)

    Baseline, Week 108

    Thinking and memory

Who could take part

Relapsing and progressive · 18 to 58

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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    History

      1. Started

        May 2015

      2. Main results due

        Jan 2016

      3. Finished

        Jan 2016

      4. Results posted

        Mar 2017

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