Actively Recruiting
Targeting Residual Activity By Precision, Biomarker-Guided Combination Therapies of Multiple Sclerosis (TRAP-MS)
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-05-07
250
Participants Needed
1
Research Sites
594 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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....
CONDITIONS
Official Title
Targeting Residual Activity By Precision, Biomarker-Guided Combination Therapies of Multiple Sclerosis (TRAP-MS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Enrolled in protocol 09-I-0032
- Clinically definite multiple sclerosis
- Age 18 years or older at enrollment
- Expanded Disability Status Scale (EDSS) score between 1.0 and 7.5
- For progressive MS: sustained clinical progression of at least 0.5 CombiWISE points per year on stable therapy or untreated, measured over 18 months or more
- For non-progressing MS with residual disability: CombiWISE slope greater than 0 and less than 0.5 units per year, with sustained residual disability (CombiWISE > 10)
- Women able to become pregnant must agree to use medically acceptable birth control during treatment
- Patients on FDA-approved disease-modifying therapies (DMTs) must keep therapy stable during the study, unless changing to higher potency therapy before age 53 with appropriate baseline assessments
- Willing and able to participate fully and provide informed consent
You will not qualify if you...
- Medical conditions posing undue risk or preventing safe study completion (e.g., significant cerebrovascular disease, ischemic cardiomyopathy, clotting disorders, other neurodegenerative diseases, substance abuse, severe psychiatric disorders, inability to tolerate MRI)
- Medical disorders requiring chronic immunosuppressive or immunomodulatory treatments other than MS
- Pregnancy or breastfeeding
- Abnormal blood test results: liver enzymes more than three times normal, low white blood cell count (<3000/mm3), low platelet count (<85,000/mm3), high serum creatinine (>2.0 mg/dL) or low kidney function (eGFR < 60)
- Positive tests for HIV, HTLV-1, or active hepatitis A, B, or C
- Drug-specific exclusions when assigned (not study-wide):
- Pioglitazone: congestive heart failure, bladder cancer history, type 1 diabetes, allergy, or taking teriflunomide
- Dantrolene: allergy, liver impairment, elevated liver tests, history of liver toxicity
- Pirfenidone: allergy, liver impairment, elevated liver tests, smoking
- Cilostazol: allergy, congestive heart failure, bleeding disorders, taking certain S1P inhibitors
- Leucovorin: allergy, active colorectal cancer, vitamin B12 deficiency
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
M
Michelle D Woodland
CONTACT
B
Bibiana Bielekova, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
2
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