Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00835770
Recruitment Status : Completed
First Posted : February 4, 2009
Last Update Posted : August 6, 2020
Sponsor:
Information provided by (Responsible Party):
Biogen

Tracking Information
First Submitted Date  ICMJE February 2, 2009
First Posted Date  ICMJE February 4, 2009
Last Update Posted Date August 6, 2020
Actual Study Start Date  ICMJE February 3, 2009
Actual Primary Completion Date November 8, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 2, 2018)
Number of Participants with Adverse Events [ Time Frame: Day 1 up to atleast 8 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 3, 2009)
To evaluate the long-term safety profile of BG00012 [ Time Frame: 2 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2018)
  • Number of Participants Who Had Relapses [ Time Frame: Day 1 up to atleast 8 years ]
  • Annualized Relapse Rate (ARR) [ Time Frame: Day 1 up to atleast 8 years ]
  • Change from Baseline in the Expanded Disability Status Scale (EDSS) for atleast 8 years [ Time Frame: Day 1 up to atleast 8 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 upto approximately 7.5 years from study start date. ]
  • Number and volume of new or newly-enlarging T2 lesions as Measured by Magnetic Resonance Imaging (MRI) [ Time Frame: Day 1 upto approximately 7.5 years from study start date. ]
  • Number and volume of T1 hypointense lesions [ Time Frame: Day 1 upto approximately 7.5 years from study start date. ]
  • Change from Baseline in Brain atrophy [ Time Frame: Day 1 upto approximately 7.5 years from study start date. ]
  • Summary of Magnetization Transfer Ratio (MTR) [ Time Frame: Day 1 upto approximately 7.5 years from study start date. ]
    MTR is used in neuroradiology to highlight abnormalities in brain structures
  • Change from Baseline in EQ-5D Health Survey (EQ-5D) for atleast 8 years [ Time Frame: Day 1 to atleast 8 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) for atleast 8 years [ Time Frame: Day 1 to atleast 8 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 for atleast 8 years [ Time Frame: Day 1 to atleast 8 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2009)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS)
Official Title  ICMJE 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
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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Relapsing-Remitting Multiple Sclerosis
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    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 atleast 8 years.
    Intervention: Drug: dimethyl fumarate
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 13, 2020)
1736
Original Estimated Enrollment  ICMJE
 (submitted: February 3, 2009)
1700
Actual Study Completion Date  ICMJE November 8, 2019
Actual Primary Completion Date November 8, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 58 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Belarus,   Belgium,   Bosnia and Herzegovina,   Bulgaria,   Canada,   Croatia,   Czechia,   Estonia,   France,   Germany,   Greece,   India,   Ireland,   Israel,   Italy,   Latvia,   Mexico,   Moldova, Republic of,   Netherlands,   New Zealand,   North Macedonia,   Poland,   Puerto Rico,   Romania,   Serbia,   Slovakia,   South Africa,   Spain,   Switzerland,   Ukraine,   United Kingdom,   United States
Removed Location Countries Czech Republic,   Guatemala,   Macedonia, The Former Yugoslav Republic of
 
Administrative Information
NCT Number  ICMJE NCT00835770
Other Study ID Numbers  ICMJE 109MS303
2008-004753-14 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Biogen
Study Sponsor  ICMJE Biogen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Biogen
PRS Account Biogen
Verification Date August 2020

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