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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 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.

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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.

Conditions Studied

Multiple Sclerosis

Interventions

  • DRUG Pioglitazone
  • DRUG clemastine fumarate
  • DRUG Dantrolene
  • DRUG Pirfenidone

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 250 participants
Start Date 2017-08-11
Est. Completion 2029-01-01
Phase Phase 1

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

2,006 total trials

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What the Registry Record Tells You About NCT03109288

The ClinicalTrials.gov registry entry for NCT03109288 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 584-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (57% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.