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Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

17-N-0083

Sponsoring Institute

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: NA

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Targeted Therapy;
Multiple Sclerosis;
Biomarkers;
Combination Therapy

Recruitment Keyword(s)

None

Condition(s)

Multiple Sclerosis

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Drug: Pioglitazone
Drug: Montelukast
Drug: Losartan
Drug: Hydroxychloroquine

Supporting Site

National Institute of Neurological Disorders and Stroke

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 75 who:

Are in protocol 09-N-0032

Have progressive MS

Can stand and walk a few steps

Take an MS drug

Design:

Participants will be screened in protocol 09-N-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.

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Eligibility

INCLUSION CRITERIA:

-Enrolled in 09-N-0032 protocol

-Clinically definite MS

-Age greater than or equal to 18 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 (measured by greater than or equal to 4 time-points regression analysis of CombiWISE values spanning at least 1.5 years in total)

-Subjects of childbearing potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study

-Patients who desire to continue their current FDA-approved DMTs based on its perceived (partial) therapeutic benefit will be enrolled with the understanding that the underlying FDA-approved therapy has to 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, but the patient will have an option to repeat the entire process: go back to greater than or equal to 1.5 year baseline period on new DMT to verify that the rate of progression remains greater than or equal to 0.5 CombiWISE points/year and then can be matched to the same monotherapy or combination therapy regimen s/he was 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 less than 3 000/mm3

-Platelet count less than 85 000/mm3

-Serum creatinine level greater than 2.0 mg/dl and eGFR (glomerular filtration rate) less than 60

--Serological evidence of HIV, HTLV-1 or active hepatitis A, B or C

--Positive pregnancy test

-Breastfeeding

-Following drug-specific exclusion criteria will be applied when assigning one of the 4 tested agents (these are not exclusions from the trial)

--Pioglitazone

----Congestive heart failure

----History of bladder carcinoma

----Type 1 diabetes

----Hypersensitivity to the drug

----Taking teriflunamide (Aubagio) because of risk of hypoglycemia on this combination

--Montelukast

----Hypersensitivity to the drug

--Hydroxychloroquine

----Retinal disease or retinal changes on OCT; significant vision loss

----Hepatic impairment

----Porphyria

----Hypersensitivity to the drug

--Losartan

----Hypersensitivity to drug

----Renal impairment

----Hepatic impairment

----Congestive heart failure


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Bibiana Bielekova, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)



Rosemarie A. Cuento, C.R.N.P.
National Institute of Neurological Disorders and Stroke (NINDS)
BG 10-CRC RM 7-5644
10 CENTER DR
BETHESDA MD 20814
(301) 451-9284
cuentora@mail.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT03109288

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