MS Clinical Trials

Bilateral Coordination of Gait
Ibudilast in Progressive MS : SPRINT-MS
RPC1063 for Relapsing and Active Multiple Sclerosis : RADIANCE
A Pilot Study of Adipokines and Calorie Restriction in Multiple Sclerosis
Completed Trials – No Longer Enrolling
Efficacy, Safety, and Tolerability of Plovamer Acetate
Vitamin D Supplementation in Multiple Sclerosis
Natalizumab in Breakthrough Disease: ESCALATE


Clinical Trials

Mission
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.

If you are interested in a specific clinical study listed below, please do not hesitate to contact the coordinator listed. If you want to get involved but unsure which study would be best, please contact Samantha Lancia (lancias@neuro.wustl.edu or 314-747-5576) for an individualized assessment and to receive more information.

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).

Not Sure or Confused
If you want to get involved, but do not know if you would fit within the criteria or do not understand any study description listed below, please call. We can learn more about you and assess your options. The studies below are currently enrolling, and we have upcoming studies not listed. We can take your information and contact you with appropriate opportunities to participate. Please contact Samantha Lancia (lancias@neuro.wustl.edu or 314-747-5576) for an assessment and information.

Funding Sources
MS studies are funded through a variety of sources, which might include:

  • The Barnes-Jewish Hospital MS Fund – contributions from patients, community members, foundations and corporations
  • The National Multiple Sclerosis Society
  • The National Institutes of Health
  • Washington University and Barnes Jewish Hospital Internal Grants
  • Industry sponsors when studying a therapy for regulatory approval

How Can I Donate Funds to Support MS Research in the St. Louis
We appreciate contributions of all sizes. Please contact us if you wish to support our mission.


Clinical Studies Currently Enrolling Patients

Trials that are Enrolling Patients (please scroll down to find more information on individual trials)

THERAPY TYPE OF PATIENT DURATION (SPONSOR)
Natalizumab Relapsing Remitting MS, ages 18-60 2 years (Biogen Idec)
Ibudilast Progressive MS (SPMS or PPMS), ages 21-65 ~26 months (NIH)
Vitamin D3 Relapsing MS, agse 18-50 2 years (NMSS)
RPC1063 (S1P Modulator) Relapsing MS, ages 8-55 2 years (Receptos, Inc.)
Calorie restriction by intermittent fasting Acute relapse (exacerbation) of MS, age 18-60 15 days to 6.5 months (Longer Life Foundation)

Other studies coming soon!


Natalizumab for Relapsing and Active Multiple Sclerosis with Breakthrough Disease on other Therapy

A Phase 4 Multicenter, Open-Label, Single Arm Study to Evaluate Switching from BRACET/Gilenya® to Natalizumab in Subjects with Relapsing Forms of Multiple Sclerosis (MS) (ESCALATE, 101MS409)
Description:
Natalizumab (Tysabri™) was approved as an effective therapy for MS in 2004. Natalizumab is administered as an infusion every 4 weeks, and works by reducing the number of inflammatory cells that get into the brain.

The rationale of this study is to determine whether natalizumab is associated with no further disease activity over 2 years (i.e. relapses, new MRI lesions, disability progression) in patients who are having breakthough disease on one of the other available MS treatments. Everyone who participants will receive natalizumab.


RPC1063 (an S1P Modulator) for Relapsing and Active Multiple Sclerosis (RADIANCE, RPC01-201-B)

A Phase 2/3, Multi-Center, Randomized, Double-Blind, Active-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of RPC1063 Administered Orally to Relapsing Multiple Sclerosis Patients (RADIANCE, RPC01-201 Part B)
Description:
RPC1063 is a once-a-day, oral, anti-inflammatory medication that works as an “S1P receptor modulator”. RPC1063 is thought to be effective in MS by reducing the number of inflammatory cells within the blood stream, thereby reducing the number of inflammatory cells that get into the brain. Another example of an S1P receptor modulator is fingolimod, which was approved for relapsing MS in 2010.

The rationale of this study is to determine the efficacy and safety of RPC1063 in relapsing forms of MS. Over two years, the study medicine will be compared to interferon beta-1a weekly (Avonex®). Participants will randomized to take either RPC1063 or the interferon.

The study will include 24 months of treatment, with a 30 day screening period before treatment, and a 4 week follow-up visit.


Ibudilast for Progressive Multiple Sclerosis (SPRINT-MS, NN102)

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Activity of Ibudilast (MN-166) in Subjects with Progressive Multiple Sclerosis
Washington University is looking for people with MS to participate in a research study to evaluate the effects of Ibudilast on Primary or Secondary Progressive MS.


Vitamin D Supplementation in Multiple Sclerosis


Walking Assessments and Spinal Cord MRI for All MS Subtypes

Neuropathogenesis of Impairments in Bilateral Coordination of Gait in Persons with Multiple Sclerosis


Is Restriction of Calories Beneficial During an MS Exacerbation?

A Pilot Study of Adipokines and Calorie Restriction in Multiple Sclerosis
Description:
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.


Completed Trials – No Longer Enrolling