Targeting Residual Activity By Precision, Biomarker-Guided Combination Therapies of Multiple Sclerosis (TRAP-MS)
Status:
Recruiting
Trial end date:
2029-01-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID) National Institute of Neurological Disorders and Stroke (NINDS)