Adults 10 to 17, any sex, with Multiple Sclerosis, Relapsing-Remitting. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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 PeriodPrimary· Baseline Period (Week -8 to Day 0), On-Treatment Assessment Period (Week 16 to Week 24)
Group
Value
95% CI
BG00012
-7.9
± 16.23
Maximum Observed Plasma Concentration (Cmax)Secondary· Day 8
Group
Value
95% CI
BG00012
1998.62
± 1286.467
Time to Reach Maximum Observed Plasma Concentration (Tmax)Secondary· Day 8
Group
Value
95% CI
BG00012
4.20
± 1.543
Apparent Clearance (CL/F)Secondary· Day 8
Group
Value
95% CI
BG00012
74.45
± 30.185
Apparent Volume of Distribution (V/F)Secondary· Day 8
Group
Value
95% CI
BG00012
98.19
± 91.679
Half-Life Lambda zSecondary· Day 8
Group
Value
95% CI
BG00012
0.84
± 0.408
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf)Secondary· Day 8
Group
Value
95% CI
BG00012
3630.52
± 1153.768
Number of Participants Who Experienced Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)Secondary· Up to Week 28
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 i
Any event
Group
Value
95% CI
BG00012
20
Moderate or severe event
Group
Value
95% CI
BG00012
7
Severe event
Group
Value
95% CI
BG00012
1
Event related to BG00012
Group
Value
95% CI
BG00012
16
Serious event
Group
Value
95% CI
BG00012
5
Serious event related to BG00012
Group
Value
95% CI
BG00012
0
Discontinued treatment due to an event
Group
Value
95% CI
BG00012
2
Withdrew from study due to an event
Group
Value
95% CI
BG00012
2
Adverse events — posted to ClinicalTrials.gov
Time frame: From first dose of study drug through end of treatment period (Week 24 ±7 days) plus 4 weeks follow-up..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06850597 — Efficacy and Safety of Dimethyl Fumarate Among Patients with Mild Cognitive Impairment and Dementia Due to Alzheimer's D
· Phase 2
· recruiting
NCT02969304 — Study of Utilization Patterns of Dimethyl Fumarate in Germany
· completed
NCT02555215 — Extension Study of BG00012 in Pediatric Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)
· Phase 3
· completed
NCT02471560 — Tecfidera and the Gut Microbiota
· Phase 4
· completed
NCT02525874 — Effect of BG00012 on Lymphocyte Subsets and Immunoglobulins in Subjects With Relapsing Remitting Multiple Sclerosis (RRM
· Phase 3
· completed
Other recruiting trials for Multiple Sclerosis, Relapsing-Remitting
Currently open trials in the same condition.
NCT06408259 — Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relap
· Phase 3
· recruiting
NCT06569550 — Fatigue Alleviation Through Neuromodulating Therapy in Multiple Sclerosis
· NA
· recruiting
NCT06389968 — Light Stimulation to Improve Visual Function After Optic Neuritis in Persons with Multiple Sclerosis
· NA
· recruiting
NCT06345157 — ITAKOS - Italian Observation, Multicenter, Prospective Study of Ofatumumab in RRMS Patients
· active not recruiting
NCT06715436 — Multiple Sclerosis and the Effects of Ketogenic Diet Therapy
· NA
· recruiting
Other Biogen trials
Trials by the same sponsor.
NCT07483632 — A Study to Learn About the Safety of Diroximel Fumarate (DRF) and Dimethyl Fumarate (DMF) and Their Effects on Relapses
· Phase 3
· not yet recruiting
NCT06628687 — A Study to Learn How BIIB141 (Omaveloxolone) Affects the Health of Participants With Friedrich's Ataxia Who Took it Duri
· recruiting
NCT07444450 — A Study to Learn About the Safety and Effects of Salanersen (BIIB115) When Given to Babies With Spinal Muscular Atrophy
· Phase 3
· not yet recruiting
NCT07444489 — A Study to Learn More About the Long-Term Safety and Effects of Felzartamab Infusions in Adults With Kidney Transplants
· Phase 3
· not yet recruiting
NCT07444476 — A Study to Learn About Salanersen's (BIIB115) Effects on Movement and Its Safety in Participants Aged 15 to 60 Years Wit
· Phase 3
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Biogen
Last refreshed: 23 October 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02410200.