RecruitingPhase 1Phase 2NCT03109288

Targeting Residual Activity By Precision, Biomarker-Guided Combination Therapies of Multiple Sclerosis (TRAP-MS)

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Enrollment

250 participants

Start Date

Aug 11, 2017

Study Type

INTERVENTIONAL

Conditions

Multiple Sclerosis

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.

Eligibility

Min Age: 18 YearsMax Age: 120 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether adding precision, biomarker-guided combination therapies can slow or stop the progression of multiple sclerosis (MS) in patients who continue to worsen despite being on an approved MS medication. **You may be eligible if...** - You have been formally diagnosed with multiple sclerosis - You are 18 years or older - You are enrolled in a related NIH natural history study (protocol 09-I-0032) - Your disability has been measurably and steadily increasing over the past 1.5 years or more, based on documented assessments - Your current FDA-approved MS medication will remain the same during the study - If you can become pregnant, you are willing to use effective birth control during the study **You may NOT be eligible if...** - You are not enrolled in the NIH natural history study - Your MS has not been progressing steadily based on documented measurements - You are not able to maintain a stable MS medication regimen during the study - You are pregnant or not willing to use birth control Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCilostazol

100 mg Bid

DRUGLeucovorin

10 mg Bid

DRUGPirfenidone

Up to 801 mg po tid. Slow titration over weeks based on tolerability: 267mg po tid x \>= 7d 534 mg po tid x \>= 7d 801 mg po tid

DRUGDantrolene

Up to 200 mg/day (divided into 3 doses of 50mg, 50mg, and 100 mg)

DRUGPioglitazone

15-45 mg po qd

Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT03109288

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