Targeting Residual Activity By Precision, Biomarker-Guided Combination Therapies of Multiple Sclerosis (TRAP-MS)
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|ClinicalTrials.gov Identifier: NCT03109288|
Recruitment Status : Recruiting
First Posted : April 12, 2017
Last Update Posted : April 25, 2018
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.
To see if signs of inflammation in CSF help predict a person s response to different drugs.
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
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:
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Drug: Pioglitazone Drug: Montelukast Drug: Losartan Drug: Hydroxychloroquine||Phase 1 Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Targeting Residual Activity By Precision, Biomarker-Guided Combination Therapies of Multiple Sclerosis (TRAP-MS)|
|Actual Study Start Date :||August 11, 2017|
|Estimated Primary Completion Date :||June 1, 2030|
|Estimated Study Completion Date :||June 1, 2030|
15-45 mg po qd
50-100mg/day (can be divided bid)
200-400 mg qd/bid
- Primary outcome will be the change in the CombiWISE progression rate at the end of monotherapy plus combination therapy period in comparison to projected baseline disability progression. [ Time Frame: Study Completion ]
- Safety and tolerability of individual drugs and their combinations [ Time Frame: Study Completion ]
- Change in the rate of ventricular atrophy between baseline, monotherapy and combination therapy periods, measured by linear regression slopes greater than or equal to 3 time-points for each period [ Time Frame: Study Completion ]
- Correlations between change(s) in CSF biomarkers and clinical efficacy (systems biology approach analyzing drugs/combinations separately and combining all drugs/combinations to a single larger cohort; exploratory analysis) [ Time Frame: Study Completion ]
- Development of new CSF (combinatorial) biomarkers, new clinical scales, new MRI outcomes will be included in exploratory analyses [ Time Frame: Study Completion ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03109288
|Contact: Rosemarie A Cuento, C.R.N.P.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Bibiana Bielekova, M.D.||National Institute of Neurological Disorders and Stroke (NINDS)|