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BG00012 and Delay of Disability Progression in Secondary Progressive Multiple Sclerosis (INSPIRE)
This study has been terminated.
(Sponsor Decision)
Sponsor:
Biogen
Information provided by (Responsible Party):
Biogen
ClinicalTrials.gov Identifier:
NCT02430532
First received: April 27, 2015
Last updated: March 27, 2017
Last verified: March 2017
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Multiple Sclerosis, Secondary Progressive | Drug: dimethyl fumarate Other: Placebo | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
U.S. FDA Resources
Further study details as provided by Biogen:
Primary Outcome Measures:
- 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:
- 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.
- 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.
- 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).
- 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.
| Enrollment: | 58 |
| Study Start Date: | May 2015 |
| Study Completion Date: | January 2016 |
| Primary Completion Date: | January 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
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:
Other: Placebo
matched placebo capsule
|
Eligibility| 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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02430532
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
| Responsible Party: | Biogen |
| ClinicalTrials.gov Identifier: | NCT02430532 History of Changes |
| Other Study ID Numbers: |
109MS308 2014-003021-18 ( EudraCT Number ) |
| Study First Received: | April 27, 2015 |
| Results First Received: | December 12, 2016 |
| Last Updated: | March 27, 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 |
ClinicalTrials.gov processed this record on July 14, 2017