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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Multiple Sclerosis, Secondary Progressive
Interventions Drug: dimethyl fumarate
Other: Placebo
Enrollment 58
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Tecfidera 240 mg BID
Hide Arm/Group Description BG00012 120 mg capsule orally once a day (QD) supplemented with matching placebo capsules for the first 4 weeks of treatment. Matched placebo capsules only thereafter for up to 108 weeks. BG00012 120 mg orally twice daily (BID) for 1 week, followed by BG00012 240 mg orally BID beginning on Day 8 for up to 108 weeks.
Period Title: Overall Study
Started 30 28
Completed 0 0
Not Completed 30 28
Reason Not Completed
Sponsor Decision to Stop Study Early             30             25
Consent Withdrawn             0             2
Adverse Event             0             1
Arm/Group Title Placebo Tecfidera 240 mg BID Total
Hide Arm/Group Description BG00012 120 mg capsule orally QD supplemented with matching placebo capsules for the first 4 weeks of treatment. Matched placebo capsules only thereafter for up to 108 weeks. BG00012 120 mg orally BID for 1 week, followed by BG00012 240 mg orally BID beginning on Day 8 for up to 108 weeks. Total of all reporting groups
Overall Number of Baseline Participants 30 28 58
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 28 participants 58 participants
50.7  (6.67) 49.6  (8.05) 50.2  (7.33)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants 28 participants 58 participants
< 20 years 0 0 0
20 to 29 years 0 0 0
30 to 39 years 1 4 5
40 to 49 years 10 8 18
>= 50 years 19 16 35
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 28 participants 58 participants
Female
19
  63.3%
17
  60.7%
36
  62.1%
Male
11
  36.7%
11
  39.3%
22
  37.9%
1.Primary Outcome
Title Time to Disability Progression Independent of Relapse
Hide Description 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.
Time Frame Up to 108 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.
Arm/Group Title Placebo Tecfidera 240 mg BID
Hide Arm/Group Description:
BG00012 120 mg capsule orally once a day (QD) supplemented with matching placebo capsules for the first 4 weeks of treatment. Matched placebo capsules only thereafter for up to 108 weeks.
BG00012 120 mg orally twice daily (BID) for 1 week, followed by BG00012 240 mg orally BID beginning on Day 8 for up to 108 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Change From Baseline to 2 Years on the 12-Item Multiple Sclerosis Walking Scale (MSWS-12)
Hide Description 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.
Time Frame Baseline, 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.
Arm/Group Title Placebo Tecfidera 240 mg BID
Hide Arm/Group Description:
BG00012 120 mg capsule orally QD supplemented with matching placebo capsules for the first 4 weeks of treatment. Matched placebo capsules only thereafter for up to 108 weeks.
BG00012 120 mg orally BID for 1 week, followed by BG00012 240 mg orally BID beginning on Day 8 for up to 108 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Change From Baseline to Week 108 in ABILHAND Questionnaire Score
Hide Description 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.
Time Frame Baseline, Week 108
Hide Outcome Measure Data
Hide Analysis Population Description
The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.
Arm/Group Title Placebo Tecfidera 240 mg BID
Hide Arm/Group Description:
BG00012 120 mg capsule orally QD supplemented with matching placebo capsules for the first 4 weeks of treatment. Matched placebo capsules only thereafter for up to 108 weeks.
BG00012 120 mg orally BID for 1 week, followed by BG00012 240 mg orally BID beginning on Day 8 for up to 108 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Percentage Change From Baseline to Week 108 in Whole Brain Volume
Hide Description Whole brain volume is measured by magnetic resonance imaging (MRI).
Time Frame Baseline, Week 108
Hide Outcome Measure Data
Hide Analysis Population Description
The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.
Arm/Group Title Placebo Tecfidera 240 mg BID
Hide Arm/Group Description:
BG00012 120 mg capsule orally QD supplemented with matching placebo capsules for the first 4 weeks of treatment. Matched placebo capsules only thereafter for up to 108 weeks.
BG00012 120 mg orally BID for 1 week, followed by BG00012 240 mg orally BID beginning on Day 8 for up to 108 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Change From Baseline to Week 108 in Cognitive Function as Measured by the Symbol Digit Modalities Test (SDMT)
Hide Description 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.
Time Frame Baseline, Week 108
Hide Outcome Measure Data
Hide Analysis Population Description
The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.
Arm/Group Title Placebo Tecfidera 240 mg BID
Hide Arm/Group Description:
BG00012 120 mg capsule orally QD supplemented with matching placebo capsules for the first 4 weeks of treatment. Matched placebo capsules only thereafter for up to 108 weeks.
BG00012 120 mg orally BID for 1 week, followed by BG00012 240 mg orally BID beginning on Day 8 for up to 108 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Up to approximately 24 weeks (overall mean time on study of 14.34, with an overall mean time on study treatment of 9.58 weeks).
Adverse Event Reporting Description Data summaries of adverse events are descriptive in nature and the comparison between treatment groups might not be appropriate due to the small number of participants and limited study follow-up duration.
 
Arm/Group Title Placebo Tecfidera 240 mg BID
Hide Arm/Group Description BG00012 120 mg capsule orally QD supplemented with matching placebo capsules for the first 4 weeks of treatment. Matched placebo capsules only thereafter for up to 108 weeks. BG00012 120 mg orally BID for 1 week, followed by BG00012 240 mg orally BID beginning on Day 8 for up to 108 weeks.
All-Cause Mortality
Placebo Tecfidera 240 mg BID
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Placebo Tecfidera 240 mg BID
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   5/28 (17.86%) 
Gastrointestinal disorders     
Enteritis  1  0/30 (0.00%)  1/28 (3.57%) 
Injury, poisoning and procedural complications     
Fall  1  0/30 (0.00%)  1/28 (3.57%) 
Femur fracture  1  0/30 (0.00%)  1/28 (3.57%) 
Nervous system disorders     
Multiple sclerosis relapse  1  0/30 (0.00%)  1/28 (3.57%) 
Trigeminal neuralgia  1  0/30 (0.00%)  1/28 (3.57%) 
Renal and urinary disorders     
Calculus ureteric  1  0/30 (0.00%)  1/28 (3.57%) 
Nephrolithiasis  1  0/30 (0.00%)  1/28 (3.57%) 
Renal colic  1  0/30 (0.00%)  1/28 (3.57%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  0/30 (0.00%)  1/28 (3.57%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Tecfidera 240 mg BID
Affected / at Risk (%) Affected / at Risk (%)
Total   9/30 (30.00%)   9/28 (32.14%) 
Gastrointestinal disorders     
Diarrhoea  1  0/30 (0.00%)  2/28 (7.14%) 
Nausea  1  0/30 (0.00%)  2/28 (7.14%) 
Vomiting  1  0/30 (0.00%)  2/28 (7.14%) 
Infections and infestations     
Upper respiratory tract infection  1  2/30 (6.67%)  0/28 (0.00%) 
Urinary tract infection  1  3/30 (10.00%)  2/28 (7.14%) 
Nervous system disorders     
Multiple sclerosis relapse  1  0/30 (0.00%)  2/28 (7.14%) 
Vascular disorders     
Flushing  1  5/30 (16.67%)  5/28 (17.86%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
The study was terminated early by the sponsor for business reasons. Efficacy, patient-reported outcomes, and pharmacodynamic data were not analyzed.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Biogen Study Medical Director
Organization: Biogen
EMail: clinicaltrials@biogen.com
Layout table for additonal information
Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT02430532    
Other Study ID Numbers: 109MS308
2014-003021-18 ( EudraCT Number )
First Submitted: April 27, 2015
First Posted: April 30, 2015
Results First Submitted: December 12, 2016
Results First Posted: March 27, 2017
Last Update Posted: April 26, 2017