Targeting Residual Activity By Precision, Biomarker-Guided Combination Therapies of Multiple Sclerosis (TRAP-MS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03109288|
Recruitment Status : Recruiting
First Posted : April 12, 2017
Last Update Posted : January 15, 2019
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 and older who:
- Are in protocol 09-I-0032
- Have progressive MS
- Can stand and walk a few steps
- Take an MS drug
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.
|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03109288
|Contact: Naomie W Gathua, R.N.||(240) firstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator:||Bibiana Bielekova, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|