Assessment of Tecfidera® in Radiologically Isolated Syndrome (RIS)
Condition: Multiple Sclerosis (MS)
MeSH terms: Multiple Sclerosis
Intervention: Tecfidera; Placebo
Intervention description: Blinded drug wallets will be dispensed during routine study appointments in 3 month supply, so that compliance can be reconciled at follow up visits and telephone consultations, and recorded in accountability logs.; Blinded drug wallets will be dispensed during routine study appointments in 3 month supply, so that compliance can be reconciled at follow up visits and telephone consultations, and recorded in accountability logs.
Intervention MeSH terms: Dimethyl Fumarate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 87.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Radiologically Isolated Syndrome (RIS)

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

          1. Males and females meeting 2009 RIS criteria

          2. Identified RIS cases with the initial MRI demonstrating anomalies suggestive of
             demyelinating disease dated > 2009

          3. 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

          4. 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

          5. MRI anomalies do not account for clinically apparent neurological impairments in
             patients

        Exclusion criteria

          1. Women who are pregnant or nursing

          2. Incomplete medical history or radiological data

          3. History of remitting clinical symptoms consistent with multiple sclerosis lasting > 24
             hours prior to CNS imaging revealing anomalies suggestive of MS

          4. History of paroxysmal symptoms associated with MS (i.e. Lhermitte's or Uhthoff's
             phenomena)

          5. CNS MRI anomalies are better accounted for by another disease process

          6. The subject is unwilling or unable to comply with the requirements of the study
             protocol

          7. Exposure to a disease modifying therapy for MS/RIS within the past 3 months

          8. Exposure to high-dose glucocorticosteroid treatment within the past 30 days

          9. Participation in other clinical trials involving treatment with a disease-modifying
             agent