ClinicalTrials.gov record NCT07863180

Tributyrin for Progressive Supranuclear Palsy (PSP): Virtual Trial

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Oct 10, 2026

Tributyrin for PSP: Phase 1b Virtual Trial - Feasibility Study

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 1/2A study that combines safety and dose-finding (phase 1) with a first look at whether the treatment has an effect (phase 2).
Age45 years old and older
SexAll
LocationUnited States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This Phase 1b/2 randomized, double-masked study tests a dietary supplement, tributyrin, taken three times daily for about 90 days versus placebo. It is a virtual feasibility trial that looks at safety and tolerability in people with Progressive Supranuclear Palsy (PSP), Parkinson disease, or Multiple System Atrophy. The study measures dropouts and serious adverse events up to about day 90.

What it is studying. Whether taking a 500 mg tributyrin supplement three times a day for about 90 days is safe and tolerable compared with placebo, and whether the supplementation plus virtual testing approach is feasible for people with PSP and related disorders.

What the researchers hope to learn. To measure tolerability (dropout rate) and safety (percent of participants with serious adverse events) of tributyrin over approximately 90 days, and to assess whether the supplementation regimen and virtual testing approach are feasible.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

This research is studying a supplement called tributyrin in people with Progressive Supranuclear Palsy (PSP) to learn about its safety and tolerability as a potential treatment. The goal of this research study is to see if a similar supplementation regimen and virtual testing is feasible for people with PSP.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • Tributyrin
  • Placebo

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Male or Female, age 45 years and over.
  • Diagnosis of PSP-Richardson syndrome (RS) based on Movement Disorder Society (MDS) Criteria, including
  • Vertical supranuclear gaze palsy.
  • Repeated unprovoked falls OR tendency to fall on the pull test within 3 years.
  • Access to the internet and webcam for virtual visits.
  • Presence of a caregiver.

Exclusion criteria

  • Recent history of significant, uncontrolled GI disease such as Gastroesophageal reflux disease, colorectal cancer.
  • Significant metabolic or uncontrolled medical comorbidity.
  • Regular use of typical anti-cholinergic drugs.
  • Women of child-bearing potential, or who are pregnant and/or nursing.
  • Suicidal ideation, as indicated by a response of 2 or 3 on question 9 of the Beck Depression Inventory.
  • Any other condition or criterion that, in the opinion of the investigators, would preclude safe and meaningful participation in the study.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

This is a sub-study of NCT07154511.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Take either tributyrin or a matching placebo, 500 mg three times a day for about 90 days, after being randomly assigned and while the study is double-masked. Participate in multiple virtual visits by internet/webcam (the record specifies a final visit called Visit 7 at approximately day 90). Report any side effects; the study records dropouts and tracks serious adverse events up to Visit 7. The registry requires access to the internet/webcam and presence of a caregiver for participation.

How the study is structured. Interventional, randomized, parallel-group, double-masked Phase 1/2 trial. Participants are randomly assigned to tributyrin 500 mg three times daily or matching placebo for roughly 90 days; the trial is run virtually to evaluate feasibility and collects safety and tolerability outcomes through visit 7 (about day 90).

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • Some participants receive a placebo. How is that decided, and what happens for placebo-group participants when the study ends?
  • This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
  • The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on multiple system atrophy

This trial is also listed on this site under progressive supranuclear palsy.

Clinical trials76 trials listed for multiple system atrophyEvery trial the registry lists for multiple system atrophy, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in multiple system atrophy researchLatest monthly update: September 2026. Includes: Tube feeding. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
September 2026 (estimated)
Primary completion
May 2027 (estimated)
Study completion
May 2027 (estimated)
Target enrollment
15 participants (estimated)
Last updated on registry
Oct 7, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Prabesh Kanel
Collaborators
  • Farmer Family Foundation

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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