CompletedPhase 3Relapsing MSNCT008357702008-004753-14

What it found

Main goal was not benefit

The main measure was safety, drug levels or similar, not whether the treatment works.

“Overall, 551 (32%) patients experienced serious adverse events (mostly multiple sclerosis (MS) relapse or fall; one progressive multifocal leukoencephalopathy); 243 (14%) discontinued treatment due to adverse events (4% gastrointestinal (GI) disorders).”
Read by software from the paper's abstract

Total participants: 1736

Read by software from the paper's abstract

What was tested

Treatment tested

Placebo or sham

  • Placebo

Results by group

Number of Participants With Treatment-Emergent Adverse Events (AEs)

Day 1 up to Week 561

GroupValueIntervalNumber analysed
BG00012 240 mg BID824 Participants868
BG00012 240 mg TID814 Participants868

BG00012 240 mg BID

824

BG00012 240 mg TID

814

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
BG00012 240 mg BID868279 (32.1%)5
BG00012 240 mg TID868272 (31.3%)6

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Number of Participants With Treatment-Emergent Adverse Events (AEs)

    Day 1 up to Week 561

    Safety
  • The primary objective and endpoint is to evaluate the long-term safety profile of BG00012.

    Safety

Other measures (16)

  • Percentage of Participants Who Had Relapses

    Day 1 up to Week 384

    Relapses
  • Annualized Relapse Rate (ARR)

    Day 1 up to Week 384

    Relapses
  • Change From Baseline in the Expanded Disability Status Scale (EDSS) at Week 384

    Baseline, Week 384

    Disability progression
  • Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI)

    Baseline up to Week 288

    MRI lesions
  • Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI)

    Baseline up to Week 288

    MRI lesions
  • Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI)

    Baseline up to Week 288

    MRI lesions
  • Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI)

    Baseline up to Week 288

    MRI lesions
  • Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI)

    Baseline up to Week 288

    MRI lesions
  • Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI)

    Baseline up to Week 288

    MRI lesions
  • Percent Change From Baseline in Brain Atrophy

    Baseline up to Week 288

    MRI lesionsBrain volume loss

Who could take part

Relapsing MS · 19 to 58

Key Inclusion Criteria: -Subjects who participated in and completed as per protocol previous BG00012 clinical studies 109MS301 (NCT00420212) or 109MS302 (NCT00451451). Key Exclusion Criteria: * Any significant change in medical history from 109MS301 or 109MS302 that would have excluded subject's participation from their previous study. * Subjects from 109MS301 or 109MS302 who discontinued oral study treatment due to an AE or due to reasons other than protocol-defined relapse/disability progression. * Subjects from 109MS301 or 109MS302 who discontinued study treatment due to disability progression or relapses and did not follow the modified visit schedule up to Week 96. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test.

Papers

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Linked trials

  • Extension of

    CONFIRM

    Phase 3 · Completed

  • Extension of

    DEFINE

    Phase 3 · Completed

Links found where a registry record names another trial's registry number.

Related trials

History

    1. Started

      Feb 2009

    2. Main results due

      Nov 2019

    3. Finished

      Nov 2019

    4. Results posted

      Dec 2020

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