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New treatment option 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?
Cilostazol is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for multiple sclerosis.
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
- 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.
- 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.
- For progressive MS cohort enrollment:
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.
- 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.
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.
- 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 \ = 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...
- 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. Change from any low potency (i.e., copaxone...
- 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- 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 - 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?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.