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Intravenous Brincidofovir as an Antiviral for Treatment of Progressive Multifocal Leukoencephalopathy: A Pilot Study

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 53 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. 3 versions Re-verified since Jul 11, 2026, no change to tracked fieldsv51-v53
  2. Eligibility criteria expanded, about 11 wordsv50 See this version in full on ClinicalTrials.gov ↗
  3. Re-verified, no change to tracked fieldsv49
  4. Study description shortened, about 12 wordsv48 See this version in full on ClinicalTrials.gov ↗
  5. Re-verified, no change to tracked fieldsv47
Show 26 earlier versionsHide 26 earlier versions
  1. Start date changed from estimate of Jun 14, 2026 to Jun 5, 2026v46
  2. Start date: Jun 11, 2026 to Jun 14, 2026v45
  3. Start date: Jun 10, 2026 to Jun 11, 2026v44
  4. Start date: Jun 9, 2026 to Jun 10, 2026v43
  5. Start date: Jun 8, 2026 to Jun 9, 2026v42
  6. Start date: Jun 7, 2026 to Jun 8, 2026v41
  7. Start date: Jun 4, 2026 to Jun 7, 2026v40
  8. Start date: Jun 3, 2026 to Jun 4, 2026v39
  9. Start date: Jun 2, 2026 to Jun 3, 2026v38
  10. Start date: Jun 1, 2026 to Jun 2, 2026v37
  11. Start date: May 28, 2026 to Jun 1, 2026v36
  12. Start date: May 27, 2026 to May 28, 2026v35
  13. Start date: May 26, 2026 to May 27, 2026v34
  14. Start date: May 25, 2026 to May 26, 2026v33
  15. Start date: May 24, 2026 to May 25, 2026v32
  16. Start date: May 21, 2026 to May 24, 2026v31
  17. Start date: May 20, 2026 to May 21, 2026v30
  18. Start date: May 19, 2026 to May 20, 2026v29
  19. Start date: May 18, 2026 to May 19, 2026v28
  20. Start date: May 17, 2026 to May 18, 2026v27
  21. Start date: May 14, 2026 to May 17, 2026v26
  22. Start date: May 13, 2026 to May 14, 2026v25
  23. Start date: May 12, 2026 to May 13, 2026v24
  24. Start date: May 11, 2026 to May 12, 2026v23
  25. Start date: May 10, 2026 to May 11, 2026v22
  26. Start date: May 7, 2026 to May 10, 2026v21
  1. Recruitment opened Start date: May 6, 2026 to May 7, 2026v20 Show 1 more changeShow less
    • Start date: May 6, 2026 to May 7, 2026
  2. Trial status: Not Yet Recruiting to Recruiting Start date: May 4, 2026 to May 6, 2026 · Site details revisedv19 Show 2 more changesShow less
    • Start date: May 4, 2026 to May 6, 2026
    • Site details revised
  3. Start date: May 3, 2026 to May 4, 2026v18
  4. Start date: Apr 30, 2026 to May 3, 2026v17
  5. Start date: Apr 29, 2026 to Apr 30, 2026v16
  6. Start date: Apr 28, 2026 to Apr 29, 2026v15
  7. Start date: Apr 27, 2026 to Apr 28, 2026v14
  8. Start date: Apr 26, 2026 to Apr 27, 2026v13
  9. Start date: Apr 23, 2026 to Apr 26, 2026v12
  10. Start date: Apr 22, 2026 to Apr 23, 2026v11
  11. Start date: Apr 21, 2026 to Apr 22, 2026v10
  12. Start date: Apr 20, 2026 to Apr 21, 2026v9
  13. Start date: Apr 19, 2026 to Apr 20, 2026v8
  14. Start date: Apr 16, 2026 to Apr 19, 2026v7
  15. Start date: Apr 15, 2026 to Apr 16, 2026v6
  16. Start date: Apr 14, 2026 to Apr 15, 2026v5
  17. Start date: Apr 13, 2026 to Apr 14, 2026v4
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Background: Progressive multifocal leukoencephalopathy (PML) is a rare and often fatal brain infection caused by the JC virus. The JC virus is common. More than half of adults have been exposed to it. Most people do not get sick from the JC virus, but in people with weakened immune systems, it can cause PML. Brincidofovir (BCV) is an antiviral drug approved to treat smallpox. Researchers want to know if it can help people with PML. Objective: To test BCV in people with PML. Eligibility: People aged 18 years or older with PML. Design: Participants will be screened. They will have a physical exam with blood tests. They will have an imaging scan of the brain with contrast dye. They will have a lumbar puncture (spinal tap): A thin needle will be inserted into their lower back to draw out a sample of the fluid around their spinal cord. BCV will be given through a tube attached to a needle inserted into a vein. Participants will receive the drug 2 times a week for 4 weeks (this is 1 cycle). If the drug is helping them, they may have up to 3 drug cycles (12 weeks). Imaging scans, spinal taps, and other tests will be repeated after every 4 weeks of treatment. Participants will have 6 follow-up visits in 1 year after treatment ends. The imaging scan, spinal tap, and other tests will be repeated at each visit.
Trial Details
NCT Number NCT07511049
Lead Sponsor National Institute of Neurological Disorders and Stroke (NINDS)
Conditions Progressive Multifocal Leukoencephalopathy
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov