Clinical trial for Multiple Sclerosis
Official title Targeting Residual Activity By Precision, Biomarker-Guided Combination Therapies of Multiple Sclerosis (TRAP-MS)
ClinicalTrials.gov ID: NCT03109288
What this study is testing
What is Cilostazol?
an investigational oral tablet being studied as a potential treatment for multiple sclerosis is designed to inhibit phosphodiesterase‑3, which can increase blood flow and reduce platelet aggregation
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to find out whether changes in inflammation markers in cerebrospinal fluid can tell which drug or drug combination will work best for a person with MS.
- Who it's for
- Adults 18 or older with progressive multiple sclerosis who can stand and walk a few steps and are already on an MS medication.
- What's involved
- Participants will receive one of four study drugs, may add a second drug later, and will have regular visits that include medical history, physical exam, blood tests, imaging, eye exam, lumbar puncture to collect cerebrospinal fluid, and optional blood‑processing or home monitoring devices.
- Time commitment
- The study can last up to 18 months of drug treatment, with two visits per year for up to six years, plus follow‑up calls after treatment changes.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 6 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 120
You may be able to join if
- 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.
- Documented sustained clinical progression of at least 0.5 CombiWISE points/year on stable therapy (or untreated)
You likely can't join if
- Clinically significant medical disorders that, in the judgment of the investigators, could expose the patient to undue risk of harm or prevent the...
- Clinically significant medical disorders, other than MS that require chronic treatment with immunosuppressive or immunomodulatory agents.
- Pregnancy or breastfeeding.
- 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.
See the full eligibility 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.
- Documented sustained clinical progression of at least 0.5 CombiWISE points/year on stable therapy (or untreated)
- If follow-up is \ = 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.
- 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.
- Because the how well it works of current DMTs decreases with patient s age so that on average, zero percent how well it works on disability progression occurs after age 53, only those patients who change to higher...
- 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.
- 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...
- Willing and able to participate in all aspects of the protocol.
- Able and willing to provide informed consent.
- 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...
- Clinically significant medical disorders, other than MS that require chronic treatment with immunosuppressive or immunomodulatory agents.
- Pregnancy or breastfeeding.
- 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.
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 6 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 120 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Bethesda, Maryland, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.