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NCT07511049
Intravenous Brincidofovir as an Antiviral for Treatment of Progressive Multifocal Leukoencephalopathy: A Pilot Study
Phase 2 trial testing Brincidofovir in Progressive Multifocal Leukoencephalopathy in 24 participants. Not yet recruiting.
31 December 2029
Quick facts
| Lead sponsor | National Institute of Neurological Disorders and Stroke (NINDS) |
|---|---|
| Phase | Phase 2 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 22 April 2026 |
| Primary completion | 31 December 2029 |
| Estimated completion | 31 December 2029 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Brincidofovir (BRINCIDOFOVIR) — full drug profile →
Conditions studied
- Progressive Multifocal Leukoencephalopathy — all drugs for Progressive Multifocal Leukoencephalopathy →
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Who can join
Adults 18 to 99, any sex, with Progressive Multifocal Leukoencephalopathy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07511049
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Brincidofovir
Trials testing the same drug.
- NCT07387367 — A Phase 3 Trial to Compare IV BCV Versus IV CDV for Treatment of Adenovirus Infection After Allo-HCT · Phase 3 · recruiting
- NCT06761677 — A Phase 1b/2 Study of Intravenous Brincidofovir in Patients With Relapsed or Refractory Lymphoma and Relapsed or Refract · Phase 1, PHASE2 · suspended
- NCT05935917 — Study Evaluating the Bioequivalence of Brincidofovir Form H and Form II Tablets in Healthy Adults · Phase 1 · completed
- NCT05511779 — Study to Confirm of the Safety and Tolerability of Brincidofovir in Subjects With BK Virus Infection (Viremia) After Kid · Phase 2 · terminated
- NCT03532035 — Open Label Study of IV Brincidofovir in Adult Transplant Recipients With Adenovirus Viremia · Phase 2 · withdrawn
Other recruiting trials for Progressive Multifocal Leukoencephalopathy
Currently open trials in the same condition.
- NCT05849467 — Central Nervous System Uptake of Anti-CD8+ T Cell Minibodies in Multiple Sclerosis and Progressive Multifocal Leukoencep · Phase 1 · recruiting
- NCT07512518 — Observational Cohort Study of Chronic Viral Infection in the Central Nervous System · recruiting
- NCT01730131 — Natural History Study of Progressive Multifocal Leukoencephalopathy (PML) · recruiting
Other National Institute of Neurological Disorders and Stroke (NINDS) trials
Trials by the same sponsor.
- NCT07137442 — Distinguishing Tics and Functional Tics Using Clinical Neurophysiological Techniques · recruiting
- NCT02522611 — Periganglionic Resiniferatoxin for the Treatment of Intractable Pain Due to Cancer-induced Bone Pain · Phase 1, PHASE2 · not yet recruiting
- NCT06615973 — Screening for Social Determinants of Health (SDOH) and Cognitive Function in Individuals With History of Stroke · recruiting
- NCT07416188 — Novel Indenoisoquinolone CMYC/TOPOISOMERASE 1 Inhibitor (LMP744) in Recurrent Glioblastoma · Phase 1, PHASE2 · not yet recruiting
- NCT07388550 — Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I) · Phase 1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07511049 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Institute of Neurological Disorders and Stroke (NINDS)
- Last refreshed: 17 April 2026
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing