Multiple Sclerosis Research

CLINICAL SUPPORT

Jim Jemelka – Research Coordinator

If you wish to participate in any of the trials or have general questions please contact our research coordinator at 713-500-7045.

CURRENT CLINICAL RESEARCH

(January 29, 2023)

We have multiple ongoing clinical trials.  The ones that are currently open to enrollment are listed below.

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

Ofatumumab, Novartis

Investigator: J. William Lindsey, MD
Treatment being tested:  Ofatumumab, currently approved as Kesimpta, depletes B lymphocytes from the blood
Purpose:  Phase IV study to assess the effectiveness of ofatumumab in young, newly diagnosed, untreated MS patients.  All patients will receive ofatumumab.
Key inclusion criteria:  relapsing MS, within 6 months of diagnosis, age 18 to 35, mild disability (EDSS 0-3.0)
Status:  enrolling

ANK700, Anokion

Investigator: J. William Lindsey, MD
Treatment being tested:  ANK700, myelin peptides bound to a glycopolymer
Purpose:  Phase I study to assess safety and tolerability of a novel treatment to induce immune tolerance to myelin.  This is potentially a very focused and safe approach to treating autoimmunity.  Treatment will be given in ascending doses.
Key inclusion criteria:  age 18-55, RRMS, able to walk 20 meters with a walker, either not on treatment or on a fumarate (Tecfidera, Vumerity, Bafiertam)
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:  Rajesh Gupta, MD
Purpose: 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.

Spinal Cord Area in Early MS, UCSF

Investigator: John Lincoln, MD, PhD
Treatment being tested:  None
Purpose:  To evaluate multi-center/multi-site reproducibility of measuring spinal cord cross-sectional using a novel rapid brain and c-spine MRI sequence.
Goal: non-contrast MRI on 10 MS patients and 5 healthy controls.
Inclusion Criteria:

  1. CIS, MS within 2 years of diagnosis, or PPMS (within 5 years of diagnosis)
  2. MS patients ages 18 to 60 with EDSS between 0 and 6
  3. 5 healthy controls (HC)

EXPERIENCE-US, Biogen

Investigator: John Lincoln, MD, PhD
Treatment being tested:  Vumerity
Purpose:  A Prospective, Observational Study Evaluating Persistence on Treatment, Safety, Tolerability, and Effectiveness of Diroximel Fumarate in the Real-World Setting
Inclusion Criteria: Patients >18 y/o prescribed Vumerity and planned to be initiated within 60 days of enrollment or already initiated, with enrollment occurring no more than 7 days since the first dose.

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.