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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00835770
Registration number
NCT00835770
Ethics application status
Date submitted
2/02/2009
Date registered
4/02/2009
Date last updated
31/12/2020
Titles & IDs
Public title
BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS)
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Scientific 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
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Secondary ID [1]
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2008-004753-14
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Secondary ID [2]
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109MS303
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Universal Trial Number (UTN)
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Trial acronym
ENDORSE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Relapsing-Remitting Multiple Sclerosis
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - dimethyl fumarate
Treatment: Drugs - Placebo
Experimental: BG00012 plus placebo - In the first phase, participants will receive BG00012 240 mg (two 120 mg capsules) twice a day (BID) and 2 placebo capsules once a day. In the second phase participants will receive open-label BG00012 240 mg BID, for atleast 8 years.
Experimental: BG00012 - In the first phase participants will receive BG00012 240 mg (two 120 mg capsules) three times a day (TID). In the second phase participants will receive open-label BG00012 240 mg BID for atleast 8 years.
Treatment: Drugs: dimethyl fumarate
BG00012 capsules
Treatment: Drugs: Placebo
Capsules taken to maintain the blind in the 240 mg BID treatment group.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Treatment-Emergent Adverse Events (AEs)
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Assessment method [1]
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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.
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Timepoint [1]
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Day 1 up to Week 561
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Secondary outcome [1]
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Percentage of Participants Who Had Relapses
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Assessment method [1]
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Relapses were defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours.
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Timepoint [1]
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Day 1 up to Week 384
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Secondary outcome [2]
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Annualized Relapse Rate (ARR)
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Assessment method [2]
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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.
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Timepoint [2]
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Day 1 up to Week 384
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Secondary outcome [3]
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Change From Baseline in the Expanded Disability Status Scale (EDSS) at Week 384
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline, Week 384
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Secondary outcome [4]
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Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI)
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Assessment method [4]
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The Gd-enhancing lesions was evaluated using MRI technique.
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Timepoint [4]
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Baseline up to Week 288
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Secondary outcome [5]
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Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI)
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Assessment method [5]
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The Gd-enhancing lesions was evaluated using MRI technique.
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Timepoint [5]
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Baseline up to Week 288
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Secondary outcome [6]
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Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI)
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Assessment method [6]
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The T2 lesions was evaluated using MRI technique.
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Timepoint [6]
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Baseline up to Week 288
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Secondary outcome [7]
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Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI)
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Assessment method [7]
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The T2 lesions was evaluated using MRI technique.
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Timepoint [7]
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Baseline up to Week 288
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Secondary outcome [8]
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Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI)
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Assessment method [8]
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The T1 hypointense lesions was evaluated using MRI technique.
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Timepoint [8]
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Baseline up to Week 288
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Secondary outcome [9]
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Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI)
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Assessment method [9]
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The T1 hypointense lesions was evaluated using MRI technique.
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Timepoint [9]
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Baseline up to Week 288
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Secondary outcome [10]
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Percent Change From Baseline in Brain Atrophy
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Assessment method [10]
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Brain atrophy was measured using magnetic resonance imaging (MRI) technique.
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Timepoint [10]
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Baseline up to Week 288
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Secondary outcome [11]
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Percent Change From Baseline in Magnetization Transfer Ratio (MTR)
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Assessment method [11]
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Magnetization Transfer Ratio (MTR) was measured using MRI technique.
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Timepoint [11]
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Baseline up to Week 288
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Secondary outcome [12]
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Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384
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Assessment method [12]
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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.
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Timepoint [12]
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Baseline, Week 384
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Secondary outcome [13]
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Change From Baseline in EuroQol 5 Dimensions Questionnaire (EQ-5D) Health Survey - EQ-5D Index Score at Week 384
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Assessment method [13]
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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.
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Timepoint [13]
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Baseline, Week 384
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Secondary outcome [14]
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Change From Baseline in EuroQol 5 Dimensions Questionnaire (EQ-5D) Health Survey - Visual Analog Scale (VAS) at Week 384
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Assessment method [14]
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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.
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Timepoint [14]
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Baseline, Week 384
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Secondary outcome [15]
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Change From Baseline in Visual Function Test Scores at Week 384
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Assessment method [15]
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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.
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Timepoint [15]
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Baseline, Week 384
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Eligibility
Key inclusion criteria
Key
-Subjects who participated in and completed as per protocol previous BG00012 clinical
studies 109MS301 (NCT00420212) or 109MS302 (NCT00451451).
Key
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Minimum age
19
Years
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Maximum age
58
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
3/02/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
8/11/2019
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Sample size
Target
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Accrual to date
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Final
1736
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Research Site - Kogarah
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Recruitment hospital [2]
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Research Site - New Lambton Heights
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Research Site - Melbourne
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Recruitment hospital [4]
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Research Site - Box Hill
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Research Site - Chatswood
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Recruitment hospital [6]
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Research Site - Fitzroy
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Recruitment hospital [7]
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Research Site - Geelong
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Recruitment hospital [8]
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Research Site - Sydney
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Recruitment postcode(s) [1]
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2217 - Kogarah
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Recruitment postcode(s) [2]
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2305 - New Lambton Heights
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Recruitment postcode(s) [3]
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3084 - Melbourne
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Recruitment postcode(s) [4]
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3128 - Box Hill
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Recruitment postcode(s) [5]
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2067 - Chatswood
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Recruitment postcode(s) [6]
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3065 - Fitzroy
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Recruitment postcode(s) [7]
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3220 - Geelong
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Recruitment postcode(s) [8]
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2000 - Sydney
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Recruitment outside Australia
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Germany
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Münster
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Germany
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Germany
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Regensburg
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Germany
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Athens
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Hyderabad
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India
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Mangalore
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Mumbai
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Pune
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Italy
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Roma
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Mexico
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Târgu Mures
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Serbia
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Belgrade
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Serbia
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Nis
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Serbia
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Novi Sad
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Kharkiv
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Kyiv
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Lviv
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Odessa
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Zaporizhzhia
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United Kingdom
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London
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Sheffield
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Stoke on Trent
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Funding & Sponsors
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Commercial sector/Industry
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Name
Biogen
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Summary
Brief summary
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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Trial website
https://clinicaltrials.gov/ct2/show/NCT00835770
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Contacts
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Biogen
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00835770
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