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: June 11, 2015
Last verified: May 2015

February 2, 2009
June 11, 2015
February 2009
August 2019   (final data collection date for primary outcome measure)
Number of Participants with Adverse Events [ Time Frame: Day 1 up to 8 years ] [ Designated as safety issue: Yes ]
To evaluate the long-term safety profile of BG00012 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
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 8 years ] [ Designated as safety issue: No ]
  • Annualized Relapse Rate (ARR) [ Time Frame: Day 1 up to 8 years ] [ Designated as safety issue: No ]
  • Change from Baseline in the Expanded Disability Status Scale (EDSS) up to 8 years [ Time Frame: Day 1 up to 8 years ] [ Designated as safety issue: No ]
    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 8 years ] [ Designated as safety issue: No ]
  • Number and volume of new or newly-enlarging T2 lesions as Measured by Magnetic Resonance Imaging (MRI) [ Time Frame: Day 1 up to 8 years ] [ Designated as safety issue: No ]
  • Number and volume of T1 hypointense lesions [ Time Frame: Day 1 up to 8 years ] [ Designated as safety issue: No ]
  • Change from Baseline in Brain atrophy up to 8 years [ Time Frame: Day 1 up to 8 years ] [ Designated as safety issue: No ]
  • Summary of Magnetization Transfer Ratio (MTR) [ Time Frame: Day 1 up to 8 years ] [ Designated as safety issue: No ]
    MTR is used in neuroradiology to highlight abnormalities in brain structures
  • Change from Baseline in EQ-5D Health Survey (EQ-5D) up to 8 years [ Time Frame: Day 1 up to 8 years ] [ Designated as safety issue: No ]
    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 8 years [ Time Frame: Day 1 up to 8 years ] [ Designated as safety issue: No ]
    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 8 years [ Time Frame: Day 1 up to 8 years ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 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 up to 8 years.
    Intervention: Drug: dimethyl fumarate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1738
August 2019
August 2019   (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.

Both
19 Years to 58 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Canada,   Croatia,   Czech Republic,   Estonia,   Germany,   Greece,   Guatemala,   Italy,   Latvia,   Mexico,   Netherlands,   New Zealand,   Poland,   Puerto Rico,   Romania,   Serbia,   Slovakia,   South Africa,   Spain,   Switzerland,   Ukraine,   United Kingdom
 
NCT00835770
109MS303, 2008-004753-14
No
Biogen
Biogen
Not Provided
Study Director: Medical Director Biogen
Biogen
May 2015

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