Hope and Opportunity

Medical advances in the diagnosis and treatment of Multiple Sclerosis (MS) offer hope to patients and families. These advances are also instrumental in guiding the treatment plans developed by our team of MS specialists. It is for this purpose of staying abreast of the latest developments in a rapidly evolving field, that we actively participate in multi-center clinical trials evaluating new treatments for MS.

Clinical trials devised to treat progression in MS are a particular emphasis of our group. A major concern of most MS patients is the progressive nature of the disease and its potential to lead to severe disability. About 50-80% of all MS patients experience progressive neurologic problems, including gait instability, decline in strength and cognitive deficits.

In addition, we participate in several other prominent clinical research studies investigating medications for symptoms associated with MS. These include pain, fatigue, and cognitive problems that are seen with patients with MS and are difficult to treat.

Finally, we are involved in a number of studies working to improve the diagnoses of MS and predict disease course. We are particularly interested in studying why a subset of patients experience progression in MS with significant physical and cognitive disability compared to others. Our cutting-edge work with high field MRI is among the first to identify cortical lesions in progressive MS.

Current Research Studies Available

We are currently recruiting for the following research studies:

POP Study:

Plegridy Observational Program (NCT02230969)

The purpose of this study is to determine the incidence of serious adverse events and evaluate long-term efficacy of Plegridy in participants with relapsing forms of MS in routine clinical practice. This study will also monitor the safety and tolerability of Plegridy, including injection site reactions (ISRs), flu-like symptoms (FLSs), and any adverse events (AEs) leading to treatment discontinuation. The study will utilize questionnaires to assess the effect of flu-like symptoms on patient-reported effectiveness of and satisfaction with prophylactic management; evaluate change in health-related quality of life, healthcare resource consumption, and treatment adherence.

Participation in this trial involves the completion of up to six (6), short questionnaires and a brief verbal survey at each routine clinical visit with Dr. Sloane (approximately every 6 months). Participants will be compensated for participating in the study.

To be considered for this trial you must be an MS patient on Plegridy according to local label (including subjects who participated in Study 105MS302 or Study 105MS303). Patients that are concurrently enrolled in any clinical trial of an investigational product are not eligible for participation in this study.

This study is sponsored by Biogen.

New Investigator-Initiated Trial:

Effect of dimethyl fumarate on neuronal function in vivo in multiple sclerosis

The purpose of this study is to evaluate the efficacy of dimethyl fumarate (Tecfidera) for preserving both neuronal functions and normalizing aberrant neuroplasticity in MS as measured by transcranial magnetic stimulation (TMS) and 0 and 3 months after initiation of treatment. This study is being conducted in collaboration with Dr. Daniel Press and the Berenson-Allen Center for Noninvasive Brain Stimulation.

To participate in this study, patients must meet the following criteria: clinically definitive relapsing-remitting MS; aged 18-69; and must be off MS treatment at time of study for 1 week only. Participants will be compensated for participating in the study. More information is available upon request.

This study is sponsored by Biogen.


Longitudinal Assessment of Neuroprotection, Treatment, and Repair in Multiple Sclerosis

The purpose of this study is to utilize a newly created Multiple Sclerosis Research Database as a new, centralized location for information collected at routine patient visits. We will utilize the database to perform statistical analyses and discover currently unknown trends. The database will include both de-identified retrospective data collected from Beth Israel Deaconess Medical Center’s electronic medical record system as well as prospective data gathered during all future patient visits. The secondary purpose of the Multiple Sclerosis Research Database is to analyze trends amongst the BIDMC MS Center patient population to generate additional sub-studies aimed at discovering novel ways to treat patients to improve their prognoses.

To participate in this study, you must be seen at least once by Dr. Sloane in the BIDMC MS Clinic.


Long-term, prospective, multinational, parallel-cohort study monitoring safety in patients with MS newly started on fingolimod once daily or treated with another approved disease modifying therapy (PASSAGE) (NCT01442194)

The purpose of this prospective study in patients with relapsing forms of MS, either newly treated with fingolimod (Gilenya) or receiving another MS therapy, is to further monitor the overall safety profile of fingolimod under conditions of routine medical practice.

The study is also meant to address other specific questions, via several sub-studies. This includes a PRO sub study, a pulmonary sub-study, and a cardiac sub-study (for fingolimod treated patients only). Subjects will be consented separately for each sub-study.

To enter this study, patients must be MS patients who are either starting fingolimod at the time of study entry or are starting, or have started within 6 months prior to study entry, another approved MS therapy. Patients previously or currently treated with cytotoxic agents or natalizumab as well as patients treated with any investigational drug are not eligible for participation in this study. Participants will be compensated for participating in the study.

This study is sponsored by Novartis.


Efficacy and Safety of Fingolimod 0.25 mg and 0.5 mg Administered Orally Once Daily With Glatiramer Acetate 20 mg Administered Subcutaneously Once Daily in Patients With Relapsing-remitting Multiple Sclerosis (NCT01633112)

Fingolimod (Gilenya) is a new and highly effective oral drug for MS. Because Fingolimod has effects on blood pressure and heart rate when the medicine is first started, this study will evaluate a lower dose for efficacy and safety in MS in comparison to FDA-approved 0.5 mg fingolimod and Copaxone.

This study will evaluate the safety, tolerability, and efficacy of fingolimod in two doses (either 0.25mg and 0.5 mg) compared to Copaxone for 12 months. This study, in part, is being conducted to determine whether side effects of fingolimod are comparable to those associated with Copaxone. This study will also assess differences in relapse rate, MRI findings (conventional and atrophy measures), and patient satisfaction with medicine.

To enter this study, patients need to have relapsing remitting MS with one relapse within the last year or 2 within the last 2 years. Participants will be compensated for participating in the study.

This study is sponsored by Novartis.


Observational Study of Tysabri in Early Relapsing-Remitting Multiple Sclerosis in Anti-JCV Antibody Negative Patients (NCT01485003)

Tysabri (or natalizumab) is one of the most effective medicines for Multiple Sclerosis. Several randomized controlled trials have showed that Tysabri reduces risk of MS relapse by 57%, which means it is more effective than any other available MS treatment. However, Tysabri is currently used for MS patients who have inadequate response to other MS treatments. Its use in the earliest stages of MS has not been systematically studied.

The purpose of the study is to find out if we can predict whether patients receiving Tysabri will remain free of disease (that is, relapse-free, clinically stable, and/or no changes by brain magnetic imaging [MRI] scans). This study will also assess how effective Tysabri is at keeping RRMS patients free of disease when patients are early in the course of the disease.

To enter this trial, patients will have to have new onset relapsing remitting MS within the last 3 years, only been treated with one MS treatment, and have negative JCV antibody screen. Participants will be compensated for participating in the study. This study is sponsored by Biogen.

ESTEEM study:

Dimethyl Fumarate (DMF) Observational Study

Dimethyl fumarate (Tecfidera) was FDA approved for commercial use in MS treatment in March, 2013. So far, this drug has proved to be a remarkable asset to the treatment of MS. However, since dimethyl fumarate is new, we still do not know as much as we should about its risks. These include risks of infection with or without reduced white blood cell counts. We do not specifically know about risks of opportunistic infections associated with similar or more potent MS treatments. Other points of possible concern are renal effects, malignancies, and hepatic effects. This study will further assess these risks. Participants will be compensated for participating in the study. This project is supported by Biogen.

Cortical Inflammation and Demyelination in Multiple Sclerosis by Combined PET and MRI

Traditionally, MS is considered a chronic inflammatory demyelinating process affecting the white matter of the brain and spinal cord. However, more recent work has showed that the gray matter or cortex is much more extensively involved in the course of the disease than previously recognized.

The most common type of cortical lesion in MS is nearest the surface of the cortex. These cortical lesions appear near areas of focal inflammation in the meninges, the covering of the brain. This led our group and others to hypothesize that areas of meningeal inflammation drives local cortical plaque formation. Preliminary work by our group and others suggests cortical lesions are numerous in patients with cognitive problems and in patients with aggressive and progressive MS.

Our group will be enrolling patients with recent onset of MS, or an aggressive form of MS, or secondary progressive MS. The study involves a 7 Tesla MRI imaging and combined MRI-PET scan, where we will measure MRI changes in relation to [11C]-PBR28 PET scanning. PBR28 is a nontoxic molecule that identifies inflammation (primarily microglia) within the brain with great sensitivity. Thus, we will correlate areas of inflammation with MRI changes. The 7 Tesla MRI is capable of identifying cortical lesions, and this data will be correlated with PET scan and neuropsychological testing results. We hope to determine whether microglial inflammation is found in areas containing cortical plaques in MS. This study is in collaboration with Martinos Center at MGH. Participants will be compensated for participating in the study.

This study is supported by funding by the National MS Society, Department of Defense, and National Institutes of Health.

Virofind (Investigator-Initiated Trial):

Viruses are known to cause central nervous system (CNS) infections such as meningitis, encephalitis and myelitis. Nonetheless in the majority of CNS infections an etiologic agent is not identified. In addition, viral infection is associated with several CNS disorders such as multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS) and cognitive impairment. However, the pathogenesis of many CNS disorders is poorly understood and whether viral replication is in fact the cause of neurological disorders in not known.

The purpose of this study is to uncover the etiology of neurological disorders. We hypothesize many neurological disorders and infections are caused by known and yet unknown viruses that are not captured by the diagnostic modalities currently available.

We will enroll adult BIDMC patients with neurological disorders and suspected CNS infections, both in the inpatient and outpatient setting. The diagnosis of neurological disorder or suspected CNS infection will be based on clinical data (history, exam, radiographic and laboratory findings such as focal neurological deficits, brain lesions evident on MR studies, pleocytosis or other CSF abnormalities). Participants will be compensated for participating in the study.

We also are involved in recently/near completed clinical trials that are not actively recruiting:

  • Efficacy, Safety, and Tolerability of Laquinimod (CONCERTO) (Teva Pharmaceuticals)
  • A Longitudinal Case-Control Study to Collect Clinical Data and Biologic Specimens for Research into Various Neurologic Diseases (Amarantus, formerly DioGenix)

Determine Your Eligibility and Ask Questions

To determine your eligibility and ask any questions you may have, please contact Ashley Flinn at aflinn@bidmc.harvard.edu or 617-667-3726. There is no cost to you for study visits or study-related care.

See more at: http://www.bidmc.org/Centers-and-Departments/Departments/Neurology/Multiple-Sclerosis-Clinic/Clinical-Trials-and-Research-in-MS.aspx#sthash.pwnbobo7.dpuf