Assessment of Tecfidera® in Radiologically Isolated Syndrome (RIS)
- Registration Number
- NCT02739542
- Lead Sponsor
- University of Texas Southwestern Medical Center
- Brief 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).
- Detailed Description
This is a multi-center, randomized, double-blinded study in which approximately 90 RIS (radiologically isolated syndrome) subjects will be treated with either Tecfidera or placebo for 2 years (1:1 randomization). Study participants, along with the treating and examining physicians, will be blinded to treatment assignment. Central Clinical and Imaging Units will screen all potential study subjects for inclusion/exclusion criteria. We expect to enroll all RIS subjects within the U.S.
Following informed consent and verification of entry criteria by the core units, study participants will be randomized 1:1 to either Tecfidera (120mg by mouth twice daily for 7 days with dose escalation to 240mg by mouth twice daily) or placebo. Clinical follow-up by the treating physician will occur at weeks 0, 48, 96, 144 and/or End of Study and during or immediately following clinical exacerbations. During clinical visits, comprehensive medical history data will be obtained by the treating physician. All reported acute or progressive clinical events will be adjudicated by the Central Clinical Unit. Clinical visits due to suspected exacerbations associated with CNS (central nervous system) demyelination, and associated diagnostic studies and treatments, will be covered under the medical standard of care by third party payers. A recommendation to re-evaluate the patient within 3 months following the clinical event to assess for extent of recovery will be made. In addition to the face-to-face visits described above, study participants will be contacted over the telephone at weeks 4, 8, 36, 60, 84, 108, and 132 to assess for medical or treatment difficulties and for study medication compliance. Standardized MRI studies of the brain will be performed at weeks 0, 96, 144 or End of Study. Clinical imaging studies of the brain and/or spinal cord performed during or immediately following the onset of a clinical exacerbation will be performed at the discretion of the site PI with scan costs covered under the medical standard of care. An end of study clinical MRI of the cervical spinal cord with and without contrast will be recommended to study participants at week 96 as medical standard of care.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 87
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo by mouth twice daily. Tecfidera Tecfidera Tecfidera (120mg by mouth twice daily for 7 days with dose escalation to 240mg by mouth twice daily)
- Primary Outcome Measures
Name Time Method The Time From Randomization to the First Demyelinating Event (Acute or Development of an Initial Symptom Resulting in a Progressive Clinical Course) 96 weeks The primary outcome measure for this trial is the time to the first acute or progressive neurological event resulting from CNS demyelination from randomization into the trial.
- Secondary Outcome Measures
Name Time Method Newly Enlarging T2 Lesions and New T2 Lesions Combined 96 weeks Newly enlarging T2 lesions and new T2 lesions combined is measured by follow-up MRI at 96 weeks in the placebo group and in the Tecfidera group.
Change in Lesion Volume on T2-weighted MRI Baseline, 96 weeks Change in lesion volume on T2-weighted MRI is measured by follow-up MRI at 96 weeks in the placebo group and in the Tecfidera group.
Change in the Number of Participants With Brain Atrophy Baseline, 96 weeks Change in the number of participants with brain atrophy is measured by follow-up MRI at 96 weeks in the placebo group and in the Tecfidera group.
Number of New T2 Lesions 96 weeks Number of new T2 lesions as measured by follow-up MRI at 96 weeks in the placebo group and in the Tecfidera group.
Number of Newly Enlarging T2 Lesions 96 weeks Number of newly enlarging T2 lesions is measured by follow-up MRI at 96 weeks in the placebo group and in the Tecfidera group.
Number of Contrast Enhancing Lesions 96 weeks Number of contrast enhancing lesions is measured by follow-up MRI at 96 weeks in the placebo group and in the Tecfidera group.
Trial Locations
- Locations (11)
Johns Hopkins University - Neurology
🇺🇸Baltimore, Maryland, United States
Keck School of Medicine - USC - Department of Neurology
🇺🇸Los Angeles, California, United States
Mayo Clinic Department of Neurology
🇺🇸Rochester, Minnesota, United States
Washington University Department of Neurology
🇺🇸Saint Louis, Missouri, United States
Cleveland Clinic - Lou Ruvo Center for Brain Health
🇺🇸Las Vegas, Nevada, United States
Oklahoma Medical Research Foundation, MS Center of Excellence
🇺🇸Oklahoma City, Oklahoma, United States
MS Clinical Care and Research Center, Dept of Neurology, Columbia University
🇺🇸New York, New York, 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