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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biogen
ClinicalTrials.gov Identifier:
NCT00835770
First received: February 2, 2009
Last updated: May 4, 2017
Last verified: May 2017
History of Changes
February 2, 2009
May 4, 2017
February 28, 2009
February 6, 2023   (Final data collection date for primary outcome measure)
Number of Participants with Adverse Events [ Time Frame: Day 1 up to 12 years ]
To evaluate the long-term safety profile of BG00012 [ Time Frame: 2 years ]
Complete list of historical versions of study NCT00835770 on ClinicalTrials.gov Archive Site
  • Number of Participants Who Had Relapses [ Time Frame: Day 1 up to 12 years ]
  • Annualized Relapse Rate (ARR) [ Time Frame: Day 1 up to 12 years ]
  • Change from Baseline in the Expanded Disability Status Scale (EDSS) up to 12 years [ Time Frame: Day 1 up to 12 years ]
    Progression of disability is defined as at least a 1.0 point increase on the EDSS from baseline EDSS 1.0 that is sustained for 24 weeks or at least a 1.5 point increase on the EDSS from baseline EDSS =0 that is sustained for 24 weeks. The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist.
  • Number and volume of Gd-enhancing lesions as Measured by Magnetic Resonance Imaging (MRI) [ Time Frame: Day 1 up to 12 years ]
  • Number and volume of new or newly-enlarging T2 lesions as Measured by Magnetic Resonance Imaging (MRI) [ Time Frame: Day 1 up to 12 years ]
  • Number and volume of T1 hypointense lesions [ Time Frame: Day 1 to 12 years ]
  • Change from Baseline in Brain atrophy up to 12 years [ Time Frame: Day 1 to 12 years ]
  • Summary of Magnetization Transfer Ratio (MTR) [ Time Frame: Day 1 to 12 years ]
    MTR is used in neuroradiology to highlight abnormalities in brain structures
  • Change from Baseline in EQ-5D Health Survey (EQ-5D) up to 12 years [ Time Frame: Day 1 to 12 years ]
    EQ-5D is a self-administered questionnaire consisting of 5 sets of 3 questions pertaining to specific health states (i.e., mobility, self-care, pain, usual activities, anxiety), a health status rating scale, and demographic questions.
  • Change from baseline in SF-36® Health Survey (SF-36) up to 12 years [ Time Frame: Day 1 to 12 years ]
    The SF-36 is a self-administered, generic health status questionnaire consisting of 36 questions that measure 8 health concepts: physical functioning, role limitations due to physical problems, bodily pain, general health perception, vitality, social functioning, role limitations due to emotional problems and mental health.
  • Change from Baseline in Visual Function test scores up to 12 years [ Time Frame: Day 1 to 12 years ]
To evaluate the long-term efficacy of BG00012 on clinical outcomes and MS brain lesions on MRI scans; and effects of BG00012 on quality of life measurements [ Time Frame: 2 years ]
Not Provided
Not Provided
 
BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS)
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
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.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Outcomes Assessor
Primary Purpose: Treatment
Relapsing-Remitting Multiple Sclerosis
  • Drug: dimethyl fumarate
    BG00012 capsules
    Other Names:
    • BG00012
    • Tecfidera
    • DMF
  • Drug: Placebo
    Capsules taken to maintain the blind in the 240 mg BID treatment group.
  • 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 up to 12 years.
    Interventions:
    • Drug: dimethyl fumarate
    • Drug: Placebo
  • 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 up to 12 years.
    Intervention: Drug: dimethyl fumarate
Gold R, Giovannoni G, Phillips JT, Fox RJ, Zhang A, Marantz JL. Sustained Effect of Delayed-Release Dimethyl Fumarate in Newly Diagnosed Patients with Relapsing-Remitting Multiple Sclerosis: 6-Year Interim Results From an Extension of the DEFINE and CONFIRM Studies. Neurol Ther. 2016 Jun;5(1):45-57. doi: 10.1007/s40120-016-0042-8. Epub 2016 Mar 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1738
February 6, 2023
February 6, 2023   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
19 Years to 58 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Austria,   Belarus,   Belgium,   Bosnia and Herzegovina,   Bulgaria,   Canada,   Croatia,   Czechia,   Estonia,   France,   Germany,   Guatemala,   India,   Ireland,   Israel,   Italy,   Latvia,   Macedonia, The Former Yugoslav Republic of,   Mexico,   Moldova, Republic of,   Netherlands,   New Zealand,   Poland,   Puerto Rico,   Romania,   Serbia,   Slovakia,   South Africa,   Spain,   Switzerland,   Ukraine,   United Kingdom,   United States
Czech Republic,   Greece
 
NCT00835770
109MS303
2008-004753-14 ( EudraCT Number )
No
Not Provided
Not Provided
Biogen
Biogen
Not Provided
Study Director: Medical Director Biogen
Biogen
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP