Bethesda, MDNCT03109288Now EnrollingIRB Ready

Multiple Sclerosis Clinical Trial in Bethesda, MD

Access cutting-edge multiple sclerosis treatment through this phase 1/2 clinical trial at a research site in Bethesda. Study-provided care at no cost to qualified participants.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Quick Self-Assessment

See if you qualify for this Bethesda location

Preparing your pre-screening questions…

Expert Care in Bethesda

Access multiple sclerosis specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related multiple sclerosis treatment provided free

Apply for This Bethesda Location

Check if you qualify for this multiple sclerosis clinical trial in Bethesda, MD

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Bethesda

    Convenient for MD residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Bethesda site if eligible
  4. 4Begin participation

About This Multiple Sclerosis Study in Bethesda

Background: In people with multiple sclerosis (MS), brain and cerebrospinal fluid (CSF) biomarkers indicate inflammation or disease. Researchers want to see if 4 drugs given alone or combined affect MS biomarkers. They want to see if a change in biomarker levels can predict which drugs a person with MS might respond to. Objective: To see if signs of inflammation in CSF help predict a person s response to different drugs. Eligibility: People ages 18 and older who: * Are in protocol 09-I-0032 * Have progressive MS * Can stand and walk a few steps * Take an MS drug Design: Participants will be screened in protocol 09-I-0032. Participants will take 1 of the 4 study drugs. Researchers will call after 1 month to see how they are doing. Some will start a second drug. They may take each drug or combination for up to 18 months. Participants will have 2 visits a year for up to 6 years. Visits include: * Medical history * Physical exam * Blood and heart tests * X-rays and scans * Eye exam and tear collection * Lumbar puncture: A needle inserted between back bones removes some CSF. * Lymphocytapheresis: Blood is removed through a needle in one arm and run through a machine. The blood is returned through a needle in the other arm. * A sensor on the forehead records blood flow and oxygen use. * Participants may get a device for testing at home. Participants will stop taking the drugs if they have taken 2 drugs together for 18 months or if they do not do well on the drugs. Participants will be called 3 months later to see how they are doing....

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Who Can Participate

Inclusion Criteria

Enrolled in 09-I-0032 protocol.
Clinically definite MS.
Age \>=18 years at time of study enrollment.
Expanded Disability Status Scale (EDSS) 1.0-7.5.
For progressive MS cohort enrollment:
Documented sustained clinical progression of at least 0.5 CombiWISE points/year on stable therapy (or untreated)
If follow-up is \<3 years, CombiWISE progression slopes are measured by \>= 4 time points regression analysis of CombiWISE values spanning at least 18 months (1.5 years)
If follow-up is \>=3 years, CombiWISE progression slopes are measured by \>= 2 time-points regression analysis of CombiWISE values spanning at least 36 months (3 years)
Because currently only NDS utilizes CombiWISE scale, the progression slopes will be determined via 09-I-0032 natural history protocol that contains completely overlapping procedures.
It is possible that after other MS centers start using CombiWISE scale, this progression criterion may be derived from outside data, as long as they are adequately documented.
For non-progressing MS with residual disability cohort enrollment:
CombiWISE slope on stable therapy (derived identically as in progressive MS cohort) \>0 and \<0.5 CombiWISE units/year (i.e., neurological deficit that is no longer improving)
CombiWISE at the end of screening period \>10 (i.e., sustained residual disability)
Women who can become pregnant must be willing to use a medically acceptable form of birth control, while being treated on this study.
Patients on current FDA-approved DMTs will be enrolled with the understanding that the underlying FDA-approved therapy must remain stable during this protocol. If patient desires and/or his/her medical condition requires changing FDA-approved DMT during the duration of this protocol, the drugs administered under this protocol will be withdrawn, to establish new baseline of CSF biomarkers under changed therapy, and, if necessary, to establish new progression rate. New baseline of CSF biomarkers on changed therapy can be established after 6 months of new therapy.
Because the efficacy of current DMTs decreases with patient s age so that on average, zero percent efficacy on disability progression occurs after age 53, only those patients who change to higher potency therapy (i.e., treatment escalation) before age 53 will need to repeat the entire process of establishing baseline progression rate: go back to \>= 1.5 year baseline period on new DMT to verify that the rate of progression remains \>=0.5 CombiWISE points/year.
Following therapeutic change that occurs before age 53 will be considered treatment escalation: 1. Initiation of any FDA-approved DMT in previously untreated subject or 2. Change from any low potency (i.e., copaxone, teriflunomide, interferon beta preparations, dimethyl or monomethyl fumarate and fingolimod) to any high potency drugs (i.e., any B-cell depleting agents, natalizumab, alemtuzumab, siponimod, ozanimod and cladribine). All other therapy changes (i.e., parallel change from low efficacy to low efficacy or from high efficacy to high efficacy, as well as discontinuation of treatment after age 53) will require new CSF baseline (6 months after such therapy change), but will not require 18 months to calculate new CombiWISE slope.
After new CSF baseline, and, if necessary, new CombiWISE progression slopes are established, patient can be matched to the same monotherapy or combination therapy regimen they were on before the immunomodulatory DMT change.
Willing and able to participate in all aspects of the protocol.
Able and willing to provide informed consent.

Exclusion Criteria

Clinically significant medical disorders that, in the judgment of the investigators, could expose the patient to undue risk of harm or prevent the patient from safely completing all required elements of the study (such as, but not limited to significant cerebrovascular disease, ischemic cardiomyopathy, clotting disorder, other neurodegenerative disorder, substance abuse or significant psychiatric disorder such as depression with suicidal ideations, unable to perform or tolerate MRI examinations).
Clinically significant medical disorders, other than MS that require chronic treatment with immunosuppressive or immunomodulatory agents.
Pregnancy or breastfeeding.
Abnormal screening/baseline blood tests exceeding any of the limits defined below:
Serum alanine transaminase or aspartate transaminase levels which are greater than three times the upper limit of normal values.
Total white blood cell count \< 3 000/mm\^3.
Platelet count \< 85 000/mm\^3.
Serum creatinine level \> 2.0 mg/dL and eGFR (glomerular filtration rate) \< 60.
Serological evidence of HIV, HTLV-1 or active hepatitis A, B or C.
Positive pregnancy test. Following drug-specific exclusion criteria will be applied when assigning specific agent (these are not exclusions from the trial):
Pioglitazone
Congestive heart failure.
History of bladder carcinoma.
Type 1 diabetes.
Hypersensitivity to the drug.
Taking teriflunomide (Aubagio) because of risk of hypoglycemia on this combination.
Hypersensitivity to the drug.
Hepatic impairment/active hepatic disease (cannot be paired with pirfenidone due to risk of cumulative hepatoxicity).
Persistent elevation of LFTs.
History of previous drug/medication or alcohol-related liver toxicities.
Pirfenidone
Hypersensitivity to the drug.
Hepatic impairment/active hepatic disease (cannot be paired with dantrolene due to risk of cumulative hepatoxicity).
Persistent elevation of LFTs.
Hypersensitivity to the drug.
Congestive heart failure.
Hemostatic disorder/active bleeding.
Taking any S1P inhibitor (i.e., fingolimod, ozanimod, Siponimod or ponesimod) due to additive risk for QTc interval prolongation and thus increasing risk of arrythmia.
Hypersensitivity to the drug.
Colorectal cancer (active).
Vitamin B12 deficiency

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Bethesda?

Yes, this clinical trial (NCT03109288) has an active research site in Bethesda, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Multiple Sclerosis Treatment Options in Bethesda, MD

If you're searching for multiple sclerosis treatment options in Bethesda, MD, this clinical trial (NCT03109288) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Bethesda research site is actively enrolling participants for this phase 1/2 clinical trial. You'll receive care from experienced multiple sclerosis specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all multiple sclerosis clinical trials near you to find additional studies recruiting in your area.

More Multiple Sclerosis Trials in Bethesda, MD

See all multiple sclerosis clinical trials recruiting in Bethesda — not just this study.

Browse Multiple Sclerosis Trials in Bethesda →

Browse More Trials by Condition

Multiple Sclerosis TrialsAll Conditions →

Ready to Join in Bethesda?

Take the first step toward participating in this groundbreaking clinical trial

Secure · Expert Care · Bethesda, MD