BG00012 and Delay of Disability Progression in Secondary Progressive Multiple Sclerosis

NCT02430532 | Terminated Phase 3 Results DMC

• 2 other identifiers: 109MS3082014-003021-18
• Study Type: interventional
• Target: 58
• Locations: 6 countries
• Sites: 18

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.

Conditions

Multiple Sclerosis, Secondary Progressive

Keywords

INSPIRE; SPMS; Tecfidera; BG00012

Outcome Measures

Primary Outcomes (1)

• Time to Disability Progression Independent of Relapse

  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 Outcomes (4)

• Change From Baseline to 2 Years on the 12-Item Multiple Sclerosis Walking Scale (MSWS-12)

  Baseline, 2 years

• Change From Baseline to Week 108 in ABILHAND Questionnaire Score

  Baseline, Week 108

• Percentage Change From Baseline to Week 108 in Whole Brain Volume

  Baseline, Week 108

• Change From Baseline to Week 108 in Cognitive Function as Measured by the Symbol Digit Modalities Test (SDMT)

  Baseline, Week 108

Study Arms (2)

Dimethyl fumarate

EXPERIMENTAL

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; Other: Placebo

Placebo

EXPERIMENTAL

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; Other: Placebo

Interventions

dimethyl fumarate DRUG

capsule

Also known as: DMF, BG00012, Tecfidera

Dimethyl fumarate; Placebo

Placebo OTHER

matched placebo capsule

Dimethyl fumarate; Placebo

Eligibility Criteria

• Age: 18 Years - 58 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (18)

Research Site

Long Beach, California, 90806, United States

Location

Research Site

San Francisco, California, 94143, United States

Location

Research Site

Tampa, Florida, 33634, United States

Location

Research Site

Vero Beach, Florida, 32960, United States

Location

Research Site

Charlotte, North Carolina, 28207, United States

Location

Research Site

Willow Grove, Pennsylvania, 19001, United States

Location

Research Site

Round Rock, Texas, 78681, United States

Location

Research Site

Brussels, 1200, Belgium

Location

Research Site

Brno, 656 91, Czechia

Location

Research Site

Hradec Králové, 500 05, Czechia

Location

Research Site

Sittard-Geleen, 6162 BG, Netherlands

Location

Research Site

Gdansk, 80-803, Poland

Location

Research Site

Katowice, Poland

Location

Research Site

Krakow, 31-505, Poland

Location

Research Site

Lodz, 93-121, Poland

Location

Research Site

Plewiska, 62-064, Poland

Location

Research Site

Poznan, 61-853, Poland

Location

Research Site

Banská Bystrica, 97404, Slovakia

Location

MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive

Interventions

Dimethyl Fumarate

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fumarates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Limitations and Caveats

The study was terminated early by the sponsor for business reasons. Efficacy, patient-reported outcomes, and pharmacodynamic data were not analyzed.

Results Point of Contact

• Title: Biogen Study Medical Director
• Organization: Biogen

clinicaltrials@biogen.com

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2015
• First Posted: April 30, 2015
• Study Start: May 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: April 26, 2017
• Results First Posted: March 27, 2017

Record last verified: 2017-03

Locations

PL (6); SL (1); US (7); BE (1); CZ (2); NL (1)