RecruitingPhase 1 / Phase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 120 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 2 visits
  • Time periods mentioned: 18 months, 6 years
  • Procedures mentioned: X-rays, Physical exams, Spinal tap (lumbar puncture)

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests drugs used alone or together in adults with multiple sclerosis (MS) that is getting worse or has caused lasting disability. Researchers want to see if signs of swelling and disease in the fluid around the brain and spinal cord help predict which drugs may work.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older and enrolled in study 09-I-0032.
  • Have a confirmed diagnosis of MS.
  • Have a score from 1.0 to 7.5 on the EDSS, a scale that measures disability from MS.
  • For the worsening MS group: have steady worsening shown by repeated disability tests over at least 18 months, while on stable treatment or no treatment.
  • For the group with lasting disability: have disability that is no longer improving and meets the study’s test score limits.
  • If taking an approved MS drug, keep that treatment stable. Changing it means stopping study drugs while new starting tests are done.
  • If you can become pregnant, be willing to use an accepted form of birth control during study treatment.
  • Be willing and able to complete all study activities and give informed consent, meaning you understand and agree to join.

Who can't join

  • Have another serious health condition that makes the study unsafe or prevents you from completing required tests, such as MRI scans.
  • Have a condition other than MS that needs long-term drugs that weaken or change the immune system.
  • Be pregnant, have a positive pregnancy test, or be breastfeeding.
  • Have liver blood test levels more than 3 times the upper normal limit.
  • Have a white blood cell count below 3,000 or a platelet count below 85,000. These cells fight infection and help blood clot.
  • Have both a creatinine level above 2.0 and an eGFR below 60. These tests measure how well the kidneys work.
  • Have blood tests showing HIV, HTLV-1, or active hepatitis A, B, or C infections.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

* 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. * Dantrolene * 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. * Smoking. * Cilostazol * 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. * Leucovorin * Hypersensitivity to the drug. * Colorectal cancer (active). * Vitamin B12 deficiency

Study sites (1)

MD