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NCT03109288 · ClinicalTrials.gov registry record · Phase 1
Targeting Residual Activity By Precision, Biomarker-Guided Combination Therapies of Multiple Sclerosis (TRAP-MS)
A Phase 1 study of Multiple Sclerosis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 250
- Enrollment target
- 1
- Study location
NCT03109288: Recruiting Phase 1 study of Multiple Sclerosis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT03109288 is a Phase 1 study of Multiple Sclerosis that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 250 participants, below the 584-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (57% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03109288, a Phase 1 study of Multiple Sclerosis, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 250 participants
- Enrollment target
- 1
- Study location
Study Summary
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 and older who: * Are in protocol 09-I-0032 * Have progressive MS * Can stand and walk a few steps * Take an MS drug Design: 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.
Primary Outcome
CombiWISE will be calculated from EDSS and SNRS scores derived from NeurEx App, to eliminate noise stemming from ambiguities in translating neurological exam to disability scores.
Conditions Studied
Interventions
- DRUG Pioglitazone
- DRUG clemastine fumarate
- DRUG Dantrolene
- DRUG Pirfenidone
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2017-08-11 |
| Est. Completion | 2029-01-01 |
| Phase | Phase 1 |
What NCT03109288 shows while recruiting
NCT03109288 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, below the 584-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (57% lower).
The record links to 1 condition, with Multiple Sclerosis appearing as the primary indexed condition, and to 4 interventions - of which Pioglitazone is the first listed.
NCT03109288 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03109288 about?
NCT03109288 is a clinical study titled "Targeting Residual Activity By Precision, Biomarker-Guided Combination Therapies of Multiple Sclerosis (TRAP-MS)". 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 wit...
What is the current status of trial NCT03109288?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 250 participants. The study started on 2017-08-11. Estimated completion is 2029-01-01.
What conditions does trial NCT03109288 study?
This clinical trial studies the following conditions: Multiple Sclerosis.
What interventions are being tested in trial NCT03109288?
The interventions under investigation include: Pioglitazone (DRUG), clemastine fumarate (DRUG), Dantrolene (DRUG), Pirfenidone (DRUG).
Who is sponsoring clinical trial NCT03109288?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03109288 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Multiple Sclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03109288's enrollment target sits among peer trials
250 67th of 315 higher than 246 of 315 other Multiple Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Sclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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