Phase 1 Multiple Sclerosis Trial, Recruiting NCT05849467 Sponsor: National Institute of Neurological Disorders and Stroke (NINDS) Condition: Multiple Sclerosis
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Phase 1 Multiple Sclerosis Trial, Recruiting

NCT05849467
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are already enrolled in a specific NINDS research study for Multiple Sclerosis (MS) OR a specific NINDS research study for PML (a rare brain infection), OR you have been evaluated and show signs of another brain or spinal cord inflammatory condition.
  • You have been diagnosed with MS based on recognized medical guidelines, OR diagnosed with a confirmed brain infection called PML, OR have another suspected or confirmed inflammatory condition of the brain or spinal cord (such as MOGAD, NMOSD, Behçet's syndrome, or neurosarcoidosis).
  • If you are in the "other neuroinflammatory disease" group, you must have had a recent brain MRI (within the last month) showing a specific type of contrast enhancement, suggesting active inflammation.
  • You are 18 years of age or older.
  • You are able to understand and are willing to sign a consent form agreeing to take part.
  • You are willing to follow all study procedures and are available for the full duration of the study.

Who may not be able to join:

  • You are currently pregnant or breastfeeding.
  • You have a medical reason why you cannot have an MRI with contrast dye or cannot safely use a 3 Tesla MRI scanner.
  • You have other medical conditions that could make it unsafe or difficult for you to take part in the study.
  • You weigh more than 350 lbs (158 kg) or your body size means you cannot fit inside the MRI or PET scan machines.
  • You have severe claustrophobia (fear of enclosed spaces) that does not improve even with anti-anxiety medication taken by mouth.
  • Your liver enzyme levels (specific blood tests called alkaline phosphatase, AST, or ALT) are too high, unless there is a known non-liver-related reason for this.
  • Your bilirubin level (a substance measured in a blood test) is too high, unless there is a known non-liver-related reason or a condition called Gilbert's syndrome.
  • Your kidneys are not working well enough, based on a specific calculation using a blood test result.
  • If you are a woman who could become pregnant, you are unable or unwilling to use highly effective birth control for at least one month before the study begins and throughout your participation.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 16 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Daniel S Reich, M.D., National Institute of Neurological Disorders and Stroke (NINDS)

Phone: (301) 496-1801

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Registry
ClinicalTrials.gov
Start date
19 October 2023
Est. completion
1 April 2030

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Infiltration of CD8+ T cells in the CNS of adults with MS and PML via PET-CT scans using a minibody with high affinity for CD8+ T cells.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 16 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov