NCT07863180 · Prabesh Kanel
Tributyrin for Progressive Supranuclear Palsy (PSP): Virtual Trial
(BUTTER2)
What this study is about
This research is studying a supplement called tributyrin in people with Progressive Supranuclear Palsy (PSP) to learn about its safety and how well patients handle the treatment 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.
View original scientific description
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
DRUG
Tributyrin
Post-biotic short chain fatty acid dietary supplement. Participants will take 500mg TID tributyrin supplement for 90 days +/- 7 days.
DRUG
Placebo
Participants will take 500mg TID placebo for 90 days +/- 7 days.
Primary outcome measures
Tolerability of tributyrin
Time frame: Visit 7 (approximately day 90)
Tolerability will be defined as the percent of patients that dropped out of the study. (# enrolled at baseline-# enrolled on visit 7)/# enrolled at baseline
Safety of tributyrin
Time frame: Up to visit 7 (approximately day 90)
Safety will be defined as the percent of patients who experienced serious adverse events.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Ann Arbor, Michigan
Collaborators
Farmer Family Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 7, 2026 · Source of record for eligibility and locations