BG00012 and Delay of Disability Progression in Secondary Progressive Multiple Sclerosis (INSPIRE)

March 27, 2017 updated by: Biogen

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium, 1200
        • Research Site
  • Czech Republic
      • Brno, Czech Republic, 656 91
        • Research Site
      • Hradec Kralove, Czech Republic, 500 05
        • Research Site
  • Netherlands
      • Sittard-Geleen, Netherlands, 6162 BG
        • Research Site
  • Poland
      • Gdansk, Poland, 80-803
        • Research Site
      • Katowice, Poland
        • Research Site
      • Krakow, Poland, 31-505
        • Research Site
      • Lodz, Poland, 93-121
        • Research Site
      • Plewiska, Poland, 62-064
        • Research Site
      • Poznan, Poland, 61-853
        • Research Site
  • Slovakia
      • Banska Bystrica, Slovakia, 97404
        • Research Site
  • United States
    • California
      • Long Beach, California, United States, 90806
        • Research Site
      • San Francisco, California, United States, 94143
        • Research Site
    • Florida
      • Tampa, Florida, United States, 33634
        • Research Site
      • Vero Beach, Florida, United States, 32960
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Research Site
    • Pennsylvania
      • Willow Grove, Pennsylvania, United States, 19001
        • Research Site
    • Texas
      • Round Rock, Texas, United States, 78681
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dimethyl fumarate
BG00012 120 mg (1 BG00012 120 mg capsule + 1 matching placebo capsule) orally twice daily (BID) for 1 week, followed by BG00012 240 mg orally BID thereafter.
Drug: dimethyl fumarate
capsule
Other Names:
  • BG00012
  • DMF
  • Tecfidera
Other: Placebo
matched placebo capsule
Experimental: Placebo
BG00012 120 mg capsule orally once a day supplemented with matching placebo capsules for the first 4 weeks of treatment, as an additional blinding measure. Matched placebo capsules only thereafter.
Drug: dimethyl fumarate
capsule
Other Names:
  • BG00012
  • DMF
  • Tecfidera
Other: Placebo
matched placebo capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Disability Progression Independent of Relapse
Time Frame: Up to 108 weeks
Time to onset of confirmed progression of disability is defined as 1 or more of the following criteria, confirmed at ≥ 6 months after start of treatment and at Week 108 using 1 or more of the following assessments: Expanded Disability Status Scale (EDSS) score increased from Baseline of ≥ 1 point if baseline EDSS ≤ 5.5, or ≥ 0.5 point if Baseline EDSS ≥ 6.0; Timed 25-Foot Walk (T25FW) ≥ 20% increase from Baseline in the time taken for the 25-foot walk; worsening on the 9-Hole Peg Test (9HPT; ≥ 20% increase from Baseline in the time taken for the 9HPT, confirmed in the same hand). The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. The T25FW is a quantitative mobility and leg function performance test where the participant is timed while walking for 25 feet. The 9HPT is a quantitative test of upper extremity function that measures the time it takes to place 9 pegs into 9 holes and then remove the pegs.
Up to 108 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to 2 Years on the 12-Item Multiple Sclerosis Walking Scale (MSWS-12)
Time Frame: Baseline, 2 years
MSWS-12 is a participant self-assessment of walking limitations due to multiple sclerosis (MS) during the past 2 weeks. It contains 12 items that measure the impact of MS on walking. Items are summed to generate a total score and transformed to a scale with a range of 0 to 100, where high scores indicate greater negative impact on walking.
Baseline, 2 years
Change From Baseline to Week 108 in ABILHAND Questionnaire Score
Time Frame: Baseline, Week 108
The ABILHAND Questionnaire measures the participant's perceived difficulty in performing everyday manual activities in the last 3 months. Participants fill in the 56-item questionnaire by estimating their own difficulty or ease in performing each of the 56 activities. Items are summed to generate a total score and transformed to a scale with a range of 0 to 100, where high scores indicate greater impact on manual ability.
Baseline, Week 108
Percentage Change From Baseline to Week 108 in Whole Brain Volume
Time Frame: Baseline, Week 108
Whole brain volume is measured by magnetic resonance imaging (MRI).
Baseline, Week 108
Change From Baseline to Week 108 in Cognitive Function as Measured by the Symbol Digit Modalities Test (SDMT)
Time Frame: Baseline, Week 108
The SDMT measures the time to pair abstract geometric symbols with specific numbers. The score is the number of correctly coded items from 0-110 in 90 seconds. A higher score indicates a better outcome.
Baseline, Week 108

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

April 27, 2015

First Submitted That Met QC Criteria

April 27, 2015

First Posted (Estimate)

April 30, 2015

Study Record Updates

Last Update Posted (Actual)

April 26, 2017

Last Update Submitted That Met QC Criteria

March 27, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 109MS308
  • 2014-003021-18 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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