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

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ClinicalTrials.gov Identifier: NCT02430532
Recruitment Status : Terminated (Sponsor Decision)
First Posted : April 30, 2015
Results First Posted : March 27, 2017
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):
Biogen

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis, Secondary Progressive Drug: dimethyl fumarate Other: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : May 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


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:
  • DMF
  • BG00012
  • 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:
  • DMF
  • BG00012
  • Tecfidera

Other: Placebo
matched placebo capsule




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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.



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Ages Eligible for Study:   18 Years to 58 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02430532


Locations
United States, California
Research Site
Long Beach, California, United States, 90806
Research Site
San Francisco, California, United States, 94143
United States, Florida
Research Site
Tampa, Florida, United States, 33634
Research Site
Vero Beach, Florida, United States, 32960
United States, North Carolina
Research Site
Charlotte, North Carolina, United States, 28207
United States, Pennsylvania
Research Site
Willow Grove, Pennsylvania, United States, 19001
United States, Texas
Research Site
Round Rock, Texas, United States, 78681
Belgium
Research Site
Bruxelles, Belgium, 1200
Czech Republic
Research Site
Brno, Czech Republic, 656 91
Research Site
Hradec Kralove, Czech Republic, 500 05
Netherlands
Research Site
Sittard-Geleen, Netherlands, 6162 BG
Poland
Research Site
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
Slovakia
Research Site
Banska Bystrica, Slovakia, 97404
Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT02430532     History of Changes
Other Study ID Numbers: 109MS308
2014-003021-18 ( EudraCT Number )
First Posted: April 30, 2015    Key Record Dates
Results First Posted: March 27, 2017
Last Update Posted: April 26, 2017
Last Verified: March 2017

Keywords provided by Biogen:
INSPIRE
SPMS
Tecfidera
BG00012

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Neoplasm Metastasis
Multiple Sclerosis, Chronic Progressive
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Neoplastic Processes
Neoplasms
Dimethyl Fumarate
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs