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Completed

NCT Number: NCT00835770

BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS)

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.

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Key information

Conditions

Relapsing-Remitting Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Attributes Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

19 year–58 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Kogarah, New South Wales, Australia

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About this study

The initial BG00012 dosage for the extension study (240 mg BID or 240 mg TID) was the same as that used in the Phase 3 Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451). Subsequent to the initiation of this study, BG00012 was approved in several countries for the treatment of MS at a dose of 240 mg BID. For this reason, all participants continuing in this study will receive the currently marketed dose of 240 mg BID.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

dimethyl fumarate

Drug

BG00012 capsules

Other names: BG00012, Tecfidera, DMF

Placebo

Drug

Capsules taken to maintain the blind in the 240 mg BID treatment group.

Primary outcomes

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

    Time frame: Day 1 up to Week 561

    An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

Secondary outcomes

  1. Percentage of Participants Who Had Relapses

    Time frame: Day 1 up to Week 384

    Relapses were defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours.

  2. Annualized Relapse Rate (ARR)

    Time frame: Day 1 up to Week 384

    The annualized relapse rate is calculated as the total number of relapses occurred during the period for all participants, divided by the total number of participant-years followed in the period.

  3. Change From Baseline in the Expanded Disability Status Scale (EDSS) at Week 384

    Time frame: Baseline, Week 384

    EDSS scale ranges from 0 (Normal neurological exam, no disability) to 10 (Death) in 0.5 unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist. Sustained disability progression was defined as at least a 1.0 point increase on the EDSS from a baseline EDSS ≥1.0 that was sustained for at least 24 weeks, or a 1.5 point increase on the EDSS from a baseline EDSS =0 that was sustained for at least 24 weeks.

  4. Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI)

    Time frame: Baseline up to Week 288

    The Gd-enhancing lesions was evaluated using MRI technique.

  5. Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI)

    Time frame: Baseline up to Week 288

    The Gd-enhancing lesions was evaluated using MRI technique.

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

    Time frame: Baseline up to Week 288

    The T2 lesions was evaluated using MRI technique.

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

    Time frame: Baseline up to Week 288

    The T2 lesions was evaluated using MRI technique.

  8. Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI)

    Time frame: Baseline up to Week 288

    The T1 hypointense lesions was evaluated using MRI technique.

  9. Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI)

    Time frame: Baseline up to Week 288

    The T1 hypointense lesions was evaluated using MRI technique.

  10. Percent Change From Baseline in Brain Atrophy

    Time frame: Baseline up to Week 288

    Brain atrophy was measured using magnetic resonance imaging (MRI) technique.

  11. Percent Change From Baseline in Magnetization Transfer Ratio (MTR)

    Time frame: Baseline up to Week 288

    Magnetization Transfer Ratio (MTR) was measured using MRI technique.

  12. Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384

    Time frame: Baseline, Week 384

    The SF-36 is a brief (36-item) scale reflecting the impact of both dysfunctions and general health perception the questionnaire measures: 1.physical function (PF),2. role physical (RF),3. bodily pain (BP),4. role emotional (RE),5. social function (SF), 6. general health (GH),7. vitality (VT), 8. mental health (MH). Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the mental component summary (MCS) score of the SF-36. The questions related to each dimension are scored on a scale from 0 (worst score) to 100 (best score), with higher scores indicating better function.

  13. Change From Baseline in EuroQol 5 Dimensions Questionnaire (EQ-5D) Health Survey - EQ-5D Index Score at Week 384

    Time frame: Baseline, Week 384

    The EQ-5D is a generic health-related quality of life instrument consisting of 2 components, EQ-5D index score and EQ-VAS. The EQ-5D provides a profile of the participant's health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, the participant is instructed to indicate whether he or she has (1) "no problems", (2) "some problems", or (3) "severe problems". A positive change from baseline indicates improvement.

  14. Change From Baseline in EuroQol 5 Dimensions Questionnaire (EQ-5D) Health Survey - Visual Analog Scale (VAS) at Week 384

    Time frame: Baseline, Week 384

    The EQ-5D is a generic health-related quality of life instrument consisting of 2 components, EQ-5D index score and EQ-VAS. In EQ-VAS participants are asked to rate their current health on a 20 centimeter (cm) scale from 0 to 100 where 0 represents "worst imaginable health state" and 100 represents "best imaginable health state". A positive change from baseline indicates improvement.

  15. Change From Baseline in Visual Function Test Scores at Week 384

    Time frame: Baseline, Week 384

    Participants were tested using the contrast level of 100%, 2.5%, and 1.25% charts, and the scores were defined as the number of letters identified correctly for each chart (the maximum score was 60). Higher scores indicate better functioning. A positive change from baseline indicates better functioning.

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

A Dose-Blind, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of Two Doses of BG00012 Monotherapy in Subjects With Relapsing-Remitting Multiple Sclerosis

Acronym: ENDORSE

Important dates

Study start
2009
Primary completion
2019
Study completion
2019
First posted
Feb 4, 2009
Registry last updated
Dec 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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