Assessment of Tecfidera® in Radiologically Isolated Syndrome (RIS)
Completed · Phase 4 · Has a placebo group
Conditions studied: Multiple Sclerosis (MS)
In brief
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).
Key facts
- Study ID
- NCT02739542
- Run by
- University of Texas Southwestern Medical Center
- People needed
- 87
- Starts
- 2016-03-19
- Expected to finish
- 2021-03-31
- Last updated by the study team
- 2022-05-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Keck School of Medicine - USC - Department of Neurology — Los Angeles, California, United States
- Johns Hopkins University - Neurology — Baltimore, Maryland, United States
- Mayo Clinic Department of Neurology — Rochester, Minnesota, United States
- Washington University Department of Neurology — St Louis, Missouri, United States
- Cleveland Clinic - Lou Ruvo Center for Brain Health — Las Vegas, Nevada, United States
- MS Clinical Care and Research Center, Dept of Neurology, Columbia University — New York, New York, United States
- Oklahoma Medical Research Foundation, MS Center of Excellence — Oklahoma City, Oklahoma, United States
- MS Treatment Center of Dallas — Dallas, Texas, United States
- UT Southwestern Medical Center — Dallas, Texas, United States
- Swedish Medical Center — Seattle, Washington, United States
- MultiCare Institute for Research and Innovation — Tacoma, Washington, United States
Full record on ClinicalTrials.gov
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