MS Clinical Trials
|The John L. Trotter MS Center clinical coordinators. Left to right: Shannon Sides, Bridgette Clay (senior research coordinator), Dana Perantie (senior research coordinator), Courtney Dula, Linda Heinrich, Susan Sommer (clinical research supervisor), and Amber Smith.
The John L. Trotter MS Center at Washington University is committed to patient care, research, and teaching. Our research revolves around the following needs and unanswered questions:
- What is the cause of MS?
- Why do people get progressive MS?
- What tools can we use in clinical practice to inform us about an individual’s disease severity, how to select the best treatment, and how to determine whether a therapy is working.
- What new treatments can be developed to help with common MS symptoms?
- What new treatments can reduce inflammation while balancing efficacy, safety, tolerability, and convenience?
- What new treatments can repair the nervous system and how will we measure whether they are successful?
- Can we prevent MS in someone at risk to develop it?
- Can we cure MS in someone who already has it?
A Critical Partnership
We cannot answer these questions without your help. We have a commitment to make this disease better until we have a cure. Your participation is appreciated and vital. Your involvement brings us one step closer to the answers.
What to Expect
We have a variety of studies, some of which take a couple minutes, others that will last up to several years. Some studies can be flexible to your schedule and optimal availability, others need you to come to a scheduled visit within a set number of days.
Whenever we discuss clinical studies with a potential participant, we always want to determine your situation to make your involvement into a positive experience.
Most clinical studies provide some reimbursement for your time. Some clinical studies may help cover travel expenses, if coming from a relatively long distance. Clinical trials that involve a treatment will typically provide the required medications, follow-up visits, labs, and MRIs as part of the protocol. This may be a consideration if you do not have health care coverage or your deductibles for medications and office visits are high. If you are currently seeing a Neurologist/MS Specialist that you like, you can continue to see that person while participating in a clinical trial.
Types of Clinical Research
Investigator-Initiated Clinical Studies are ideas, questions, and protocols that are developed by Physicians and Scientists at the John L. Trotter MS Center. Some study protocol examples might include blood draws, questionnaires, a clinical assessments, or MRIs. They can involve a therapy, but most often relay on clinical and laboratory assessments. They can be as short as a couple minutes, or may have a number of visits over several months or years.
Industry-Sponsored Clinical Trials are typically performed for regulatory/FDA approval of new therapies. These trials are sponsored by the manufacturer of a treatment seeking either approval for a new indication on the package label. These studies are classified as Phase I, II, III, and IV. Clinical Trials are most frequently done through an outside coordinating organization that works on behalf of a manufacturer/developer, and can involve a dozen to over a hundred sites around the world. Washington University is one of those sites, and we are contracted to enroll participants, provide treatment, perform assessments, and collect all the information for regulatory submission. These studies can last anywhere from 6 months to 3 years. After enrollment, visits are often quarterly, but can vary based upon the protocol. The clinical trial supplies the therapy being studied along with any comparator therapy, and covers the costs of the protocol-defined clinical assessments, office visits, labs, and MRI scans. Participants are often not aware of which treatment they are receiving (blinded) and we do not get to pick which treatment your will receive (randomized). Sometimes the study will provide you the option for additional visits after the main study, with the study treatment supplied to everyone (open-label extension).
Clinical Studies Currently Enrolling Patients
Trials that are Enrolling Patients (please scroll down to find more information on individual trials)
||TYPE OF PATIENT
|Calorie restriction by intermittent fasting
||Acute relapse (exacerbation) of MS, age 18-60
||15 days to 6.5 months (Longer Life Foundation)
A Pilot Study of Adipokines and Calorie Restriction in Multiple Sclerosis
Multiple sclerosis (MS) is an inflammatory disease of the central nervous system (CNS) mediated by immune and neurodegenerative mechanisms. It is a major cause of disability in young adults. Risk of MS is increased about 2-fold by a high body mass index (BMI). Fat tissue is a source of molecules, collectively known as adipokines that can regulate immune and inflammatory responses.
The purpose of this study is to investigate the effects of a regimen of calorie restriction (achieved by alternate day fasting) in MS patients experiencing a relapse on several blood factors and clinical outcomes.