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

This study has been terminated.

(Sponsor Decision)

Sponsor:

Information provided by (Responsible Party):

Biogen

ClinicalTrials.gov Identifier:

NCT02430532

First received: April 27, 2015

Last updated: March 27, 2017

Last verified: March 2017

History of Changes

Tracking Information

First Received Date ^ICMJE

April 27, 2015

Last Updated Date

March 27, 2017

Start Date ^ICMJE

May 2015

Primary Completion Date

January 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Time to onset of confirmed progression of disability as measured by worsening on one or more of the Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW) or 9-Hole Peg Test (9HPT) [ Time Frame: Up to 108 weeks ]

Confirmed progression of disability is defined as one or more of the following criteria, confirmed at a second visit ≥6 months later and at week 108 using one or more of the following assessments: 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 (increase must be 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.

Change History

Complete list of historical versions of study NCT02430532 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Change From Baseline to 2 Years on the 12-Item Multiple Sclerosis Walking Scale (MSWS-12) [ Time Frame: Up to 108 weeks ]
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: Up to 108 weeks ]
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: Up to 108 weeks ]
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: Up to 108 weeks ]
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.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

BG00012 and Delay of Disability Progression in Secondary Progressive Multiple Sclerosis

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator
Primary Purpose: Treatment

Condition ^ICMJE

Multiple Sclerosis, Secondary Progressive

Intervention ^ICMJE

Drug: dimethyl fumarate
capsule
Other Names:
- DMF
- BG00012
- Tecfidera
Other: Placebo
matched placebo capsule

Study Arms

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.
Interventions:
- Drug: dimethyl fumarate
- Other: Placebo
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.
Interventions:
- Drug: dimethyl fumarate
- Other: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

January 2016

Primary Completion Date

January 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 58 Years (Adult)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Belgium, Czech Republic, Netherlands, Poland, Slovakia, United States

Removed Location Countries

Austria, Sweden

Administrative Information

NCT Number ^ICMJE

NCT02430532

Other Study ID Numbers ^ICMJE

109MS308
2014-003021-18 ( EudraCT Number )

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Biogen

Study Sponsor ^ICMJE

Biogen

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Director

Biogen

PRS Account

Biogen

Verification Date

March 2017

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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