Assessment of Tecfidera® in Radiologically Isolated Syndrome (RIS) (NCT02739542) | Clinical Trial Compass
CompletedPhase 4
Assessment of Tecfidera® in Radiologically Isolated Syndrome (RIS)
United States87 participantsStarted 2016-03-19
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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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:
✓. 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
What they're measuring
1
The Time From Randomization to the First Demyelinating Event (Acute or Development of an Initial Symptom Resulting in a Progressive Clinical Course)
Timeframe: 96 weeks
Trial details
NCT IDNCT02739542
SponsorUniversity of Texas Southwestern Medical Center