Randomized, Double-blinded Study of Treatment:Teriflunomide, in Radiologically Isolated Syndrome
Status:
Active, not recruiting
Trial end date:
2022-10-24
Target enrollment:
Participant gender:
Summary
Multiple sclerosis (MS) is a common cause of severe neurological disability in young adults,
resulting from an autoimmune interruption of both myelin and axons within the central nervous
system (CNS). The diagnosis is made by fulfilling both spatial criteria, by meeting the
requisite number of lesions within the brain or spinal cord, along with criteria for time, by
demonstrating a history of at least a second clinical attack or the development of a new MS
lesion on MRI after the seminal neurological event. In the case of MS, healthy individuals
who do not exhibit signs of neurological dysfunction commonly have brain MRI studies
performed for a reason other than an evaluation for MS that reveal unexpected anomalies
highly suggestive of demyelinating plaques given their size, location, and morphology. These
healthy subjects lack symptomatology suggestive of MS and fulfill formal criteria for
radiologically isolated syndrome (RIS), a recently described MS subtype that expands upon the
phenotype of at-risk individuals for future demyelinating events. The discovery of such
anomalies creates intersecting neuro-ethical, legal, social, and practical medical management
quandaries and is, therefore, of both immediate and long-term clinical significance. Despite
advancements in the characterization of RIS subjects, and in our understanding of risk
factors for initial symptom development, the effect of treatment on such cases remain
unclear.
The purpose of this investigation is to systematically study the efficacy of Teriflunomide in
those individuals who possess incidental white matter anomalies within the brain and
following a MRI study that is performed for a reason other than for the evaluation of MS.
RIS subjects are frequently exposed to disease modifying therapies despite the lack of
scientific literature supporting the use of such treatments. Earlier treatment intervention
may extend the time to the first acute or progressive clinical event resulting from CNS
demyelination and reduce radiological progression. In addition, early treatment may result in
more profound effects on reducing disability progression long-term.
The primary outcome measure for this trial is the time to the first acute or progressive
neurological event resulting from CNS demyelination.
This study will include RIS subjects from the Europe who fulfill 2009 RIS Criteria.