Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With RRMS
FOCUS
Open-Label, Multicenter, Multiple-Dose Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis Aged 10 to 17 Years
2 other identifiers
interventional
22
10 countries
12
Brief Summary
The primary objective of this study is to evaluate the effect of BG00012 (dimethyl fumarate) on brain magnetic resonance imaging (MRI) lesions in pediatric participants with relapsing-remitting multiple sclerosis (RRMS). The secondary objectives of this study are to characterize the pharmacokinetics of BG00012 in pediatric participants with RRMS and to evaluate the safety and tolerability of BG00012 in pediatric participants with RRMS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2015
Shorter than P25 for phase_2
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 2, 2015
CompletedFirst Posted
Study publicly available on registry
April 7, 2015
CompletedStudy Start
First participant enrolled
September 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 23, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 23, 2016
CompletedResults Posted
Study results publicly available
April 28, 2017
CompletedOctober 23, 2017
September 1, 2017
12 months
April 2, 2015
March 20, 2017
September 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the Number of New or Newly Enlarging T2 Hyperintense Lesions on Brain Magnetic Resonance Imaging (MRI) Scans From the Baseline Period to On-Treatment Assessment Period
Baseline Period (Week -8 to Day 0), On-Treatment Assessment Period (Week 16 to Week 24)
Secondary Outcomes (7)
Maximum Observed Plasma Concentration (Cmax)
Day 8
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Day 8
Apparent Clearance (CL/F)
Day 8
Apparent Volume of Distribution (V/F)
Day 8
Half-Life Lambda z
Day 8
- +2 more secondary outcomes
Study Arms (1)
BG00012
EXPERIMENTALOral BG00012 120 mg twice daily (BID) for the first 7 days followed by 240 mg BID for 24 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Ability of parents or legal guardians to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local subject privacy regulations. Subjects will provide assent in addition to the parent or legal guardian, as appropriate, as per local regulations.
- Must have a body weight of ≥30 kg at Screening and Day 1.
- Must have a diagnosis of RRMS according to McDonald criteria for MS (2010) \[Polman 2011\] and International Pediatric Multiple Sclerosis (MS) Study Group criteria for pediatric MS (2013) \[Krupp 2013\].
You may not qualify if:
- Primary progressive, secondary progressive, or progressive relapsing MS (as defined by \[Lublin and Reingold 1996\]). These conditions require the presence of continuous clinical disease worsening over a period of at least 3 months. Subjects with these conditions may also have superimposed relapses but are distinguished from relapsing-remitting subjects by the lack of clinically stable periods or clinical improvement.
- Disorders mimicking MS, such as other demyelinating disorders (e.g., acute disseminated encephalomyelitis), systemic autoimmune disorders (e.g., Sjögren disease, lupus erythematosus, and neuromyelitis optica), metabolic disorders (e.g., dystrophies), and infectious disorders.
- History of severe allergic or anaphylactic reactions or known drug hypersensitivity to dimethyl fumarate or fumaric acid esters.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (12)
Research Site
San Bernardino, California, 92408, United States
Research Site
Ghent, B-9000, Belgium
Research Site
Sofia, B-1113, Bulgaria
Research Site
Hradec Králové, 500 05, Czechia
Research Site
München, Bavaria, 80337, Germany
Research Site
Göttingen, Lower Saxony, 37075, Germany
Research Site
Dasman, Kuwait City, 15462, Kuwait
Research Site
Riga, LV-1004, Latvia
Research Site
Beirut, 1107 2020, Lebanon
Research Site
Gdansk, 80-952, Poland
Research Site
Poznan, 60-355, Poland
Research Site
Ankara, 06100, Turkey (Türkiye)
Related Publications (1)
Alroughani R, Das R, Penner N, Pultz J, Taylor C, Eraly S. Safety and Efficacy of Delayed-Release Dimethyl Fumarate in Pediatric Patients With Relapsing Multiple Sclerosis (FOCUS). Pediatr Neurol. 2018 Jun;83:19-24. doi: 10.1016/j.pediatrneurol.2018.03.007. Epub 2018 Mar 22.
PMID: 29681490DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Biogen Study Medical Director
- Organization
- Biogen
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 2, 2015
First Posted
April 7, 2015
Study Start
September 30, 2015
Primary Completion
September 23, 2016
Study Completion
September 23, 2016
Last Updated
October 23, 2017
Results First Posted
April 28, 2017
Record last verified: 2017-09