Phase 4 N=87 Randomized Quadruple-blind Treatment

Assessment of Tecfidera® in Radiologically Isolated Syndrome (RIS)

Multiple Sclerosis (MS)

Bottom Line

View on ClinicalTrials.gov: NCT02739542 ↗

Enrolled (actual)

Serious AEs

9.2%

Results posted

May 2022

Primary outcome: Primary: The Time From Randomization to the First Demyelinating Event (Acute or Development of an Initial Symptom Resulting in a Progressive Clinical Course) — 89.69; 77.81 weeks

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Tecfidera (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Texas Southwestern Medical Center
Primary completion: Mar 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY The Time From Randomization to the First Demyelinating Event (Acute or Development of an Initial Symptom Resulting in a Progressive Clinical Course)	89.69; 77.81	—
SECONDARY Change in Lesion Volume on T2-weighted MRI	0.005; 0.04	—
SECONDARY Number of Newly Enlarging T2 Lesions	0.03; 0.10	—
SECONDARY Number of New T2 Lesions	0.09; 0.54	—
SECONDARY Newly Enlarging T2 Lesions and New T2 Lesions Combined	0.12; 0.62	—
SECONDARY Number of Contrast Enhancing Lesions	0.07; 0	—
SECONDARY Change in the Number of Participants With Brain Atrophy	—	—

Summary

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).

Eligibility Criteria

Inclusion criteria

Males and females meeting 2009 RIS criteria
Identified RIS cases with the initial MRI demonstrating anomalies suggestive of demyelinating disease dated > 2009
Incidental anomalies identified on MRI of the brain or spinal cord with the primary reason for the acquired MRI resulting from an evaluation of a process other than MS
CNS white matter anomalies meeting the following MRI criteria:
Ovoid, well-circumscribed, and homogeneous foci with or without involvement of the corpus callosum
T2-hyperintensities measuring > 3mm2 and fulfilling 3 of 4 Barkhof-Tintoré criteria for dissemination in space
CNS anomalies not consistent with a vascular pattern
Qualitative determination that CNS anomalies have a characteristic appearance of demyelinating lesions
MRI anomalies do not account for clinically apparent neurological impairments in patients

Exclusion criteria

Women who are pregnant or nursing
Incomplete medical history or radiological data
History of remitting clinical symptoms consistent with multiple sclerosis lasting > 24 hours prior to CNS imaging revealing anomalies suggestive of MS
History of paroxysmal symptoms associated with MS (i.e. Lhermitte's or Uhthoff's phenomena)
CNS MRI anomalies are better accounted for by another disease process
The subject is unwilling or unable to comply with the requirements of the study protocol
Exposure to a disease modifying therapy for MS/RIS within the past 3 months
Exposure to high-dose glucocorticosteroid treatment within the past 30 days
Participation in other clinical trials involving treatment with a disease-modifying agent

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02739542). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.