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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Research Site
San Bernardino, California, United States
Research Site
Ghent, Belgium
Research Site
Sofia, Bulgaria
Research Site
Hradec Králové, Czechia
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
Time frame: Baseline Period (Week -8 to Day 0), On-Treatment Assessment Period (Week 16 to Week 24)
Maximum Observed Plasma Concentration (Cmax)
Time frame: Day 8
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: Day 8
Apparent Clearance (CL/F)
Time frame: Day 8
Apparent Volume of Distribution (V/F)
Time frame: Day 8
Half-Life Lambda z
Time frame: Day 8
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf)
Time frame: Day 8
Number of Participants Who Experienced Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AE: any untoward medical occurrence that does not necessarily have a causal relationship with treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Research Site
München, Bavaria, Germany
Research Site
Göttingen, Lower Saxony, Germany
Research Site
Dasman, Kuwait City, Kuwait
Research Site
Riga, Latvia
Research Site
Beirut, Lebanon
Research Site
Gdansk, Poland
...and 2 more locations
Time frame: Up to Week 28