18 and older, any sex, with Multiple Sclerosis (MS). 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.
The Time From Randomization to the First Demyelinating Event (Acute or Development of an Initial Symptom Resulting in a Progressive Clinical Course)Primary· 96 weeks
The primary outcome measure for this trial is the time to the first acute or progressive neurological event resulting from CNS demyelination from randomization into the trial.
Group
Value
95% CI
Tecfidera
89.69
± 23.99
Placebo
77.81
± 32.19
Change in Lesion Volume on T2-weighted MRISecondary· Baseline, 96 weeks
Change in lesion volume on T2-weighted MRI is measured by follow-up MRI at 96 weeks in the placebo group and in the Tecfidera group.
Group
Value
95% CI
Tecfidera
0.005
± 0.03
Placebo
0.04
± 0.03
Number of Newly Enlarging T2 LesionsSecondary· 96 weeks
Number of newly enlarging T2 lesions is measured by follow-up MRI at 96 weeks in the placebo group and in the Tecfidera group.
Group
Value
95% CI
Tecfidera
0.03
± 0.003
Placebo
0.10
± 0.07
Number of New T2 LesionsSecondary· 96 weeks
Number of new T2 lesions as measured by follow-up MRI at 96 weeks in the placebo group and in the Tecfidera group.
Group
Value
95% CI
Tecfidera
0.09
± 0.06
Placebo
0.54
± 0.28
Newly Enlarging T2 Lesions and New T2 Lesions CombinedSecondary· 96 weeks
Newly enlarging T2 lesions and new T2 lesions combined is measured by follow-up MRI at 96 weeks in the placebo group and in the Tecfidera group.
Group
Value
95% CI
Tecfidera
0.12
± 0.07
Placebo
0.62
± 0.30
Number of Contrast Enhancing LesionsSecondary· 96 weeks
Number of contrast enhancing lesions is measured by follow-up MRI at 96 weeks in the placebo group and in the Tecfidera group.
Group
Value
95% CI
Tecfidera
0.07
± 0.38
Placebo
0
± 0
Adverse events — posted to ClinicalTrials.gov
Time frame: 2 years.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Tecfidera
Serious: 4/44 (9%)
Deaths: 0/44
Placebo
Serious: 4/43 (9%)
Deaths: 0/43
Serious adverse events (8 terms)
Reaction
System
Tecfidera
Placebo
Procedural headache
Injury, poisoning and procedural complications
—
—
Spondylolysis
Musculoskeletal and connective tissue disorders
—
—
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Invasive ductal breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Renal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The purpose of this investigation is to systematically study the efficacy of Tecfidera in those individuals who possess incidental white matter anomalies within the brain following a MRI study that is performed for a reason other than for the evaluation of MS (multiple sclerosis).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04022473 — Study to Compare GI Tolerability Following Oral Administration of Bafiertam™ or Tecfidera to Healthy Volunteers
· Phase 1
· completed
NCT02975349 — A Study of Efficacy and Safety of M2951 in Participants With Relapsing Multiple Sclerosis
· Phase 2
· terminated
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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 University of Texas Southwestern Medical Center
Last refreshed: 11 May 2022
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/NCT02739542.