ATA188-MS-101, Atara Biotherapeutics
Investigator: J. William Lindsey, MD
Treatment being tested: Immune cells specific for Epstein-Barr virus
Purpose: The long term goal is to use white blood cells specific for EBV as a treatment for MS. This is a phase I study in progressive MS, and the main objective is to assess safety and tolerability of the treatment. The results from the first 4 groups of subjects are encouraging. Age 18 to 55.
Status: Enrollment is ongoing as of September, 2020 and will likely end in 2021
Ocarina: Subcutaneous ocrelizumab, Genentech
Investigator: J. William Lindsey, MD
Treatment being tested: Ocrevus, given subcutaneously
Purpose: To see if Ocrevus can be given sc rather than iv. Ocrelizumab is a very effective agent for treating MS, and is approved for treatment of both relapsing and progressive disease since March, 2017. This study will test whether it can be given by injection under the skin instead of by intravenous infusion, and determine the best dose.
Status: Enrolling
Evobrutinib, EMD Serono
Investigator: J. William Lindsey, MD
Treatment being tested: Evobrutinib, an agent that inhibits B lymphocytes and macrophages
Purpose: Phase III study to compare the effect of evobrutinib, a new oral agent, to Aubagio, an approved oral medicine. The phase II results were promising. Subjects will be randomized to one of the two groups.
Key inclusion criteria: Relapsing MS. Age 18 to 55.
Status: enrolling
Fenebrutinib, Genentech
Investigator: J. William Lindsey, MD
Treatment being tested: Fenebrutinib, an agent that inhibits B lymphocytes and macrophages
Purpose: Phase III study to compare the effect of fenebrutinib, a new oral agent, to Ocrevus, an approved medicine for PPMS.
Key inclusion criteria: Primary progressive MS. Age 18 to 65.
Status: enrolling
Ravalizumab, Alexion
Investigator: John Lincoln, MD, PhD
Treatment being tested: Ravalizumab
Purpose: To see if Ravalizumab is effective in neuromyelitis optica (NMO). This drug is very similar to eculizumab which was recently found to be very effective and approved for treatment of NMO, but should be more convenient since the dosing is less frequent.
Status: Enrollment ongoing and likely to close soon
North American Registry for Care and Research in MS (NARCRMS)
Investigator: Rohini Samudralwar, MD
The purpose of NARCRMS is to establish a national registry and longitudinal database of clinical and patient-based information related to multiple sclerosis. It seeks to establish “Cores” of repositories of clinical, genetic, and radiological data, and various biomaterials for developing biomarkers for this disorder across the United States as well as to develop “Research Interest Groups” (RIGS) from within the participating centers to promote collaborative efforts to utilize the data as they become available, to address specific unanswered questions in this disorder.
Status: Enrollment ongoing.
Determining the effectiveness of early intensive versus escalation approaches for RRMS (DELIVER-MS)
Investigator: Rohini Samudralwar, MD
Treatments: multiple, high versus low effectiveness
Purpose: There are currently multiple available treatments for MS, with little evidence on when to choose each. This study will enroll newly diagnosed patients and compare outcomes in a group started on safer, but less effective treatments to the group started on more effective treatments with more potential side effects.
Key Inclusion Criteria: Treatment-naïve RRMS
Status: Enrollment ongoing
Epstein-Barr Virus & MS
Investigator: J. William Lindsey, M.D.
EBV is a common virus which has been linked to MS in several different studies. Some people think that EBV may be one of the causes of MS. Dr. Lindsey is investigating the connection between EBV and MS and is currently testing whether antibodies to EBV cause damage to brain cells. Participants will donate a blood sample to be used for measurements of EBV-specific immune responses.
Tremor in MS, CDMRP
Investigator: John Lincoln, MD, PhD
Treatment: none
Purpose: Some people with MS have very severe tremor. The purpose of this study is to figure out what areas and networks in the brain are affected to cause the tremor. Subjects will have one or two MRI scans. Ideally, subjects will have tremor which is worse on one side.