Tributyrin for Progressive Supranuclear Palsy (PSP): Virtual Trial
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age45+
SponsorPrabesh Kanel
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Tributyrin
DrugPost-biotic short chain fatty acid dietary supplement. Participants will take 500mg TID tributyrin supplement for 90 days +/- 7 days.
Placebo
DrugParticipants will take 500mg TID placebo for 90 days +/- 7 days.
Treatment groups
15 Participants
are divided into 2 treatment groupsGroup A: TributyrinExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Tolerability of tributyrin
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
Time frame
Visit 7 (approximately day 90)2
Safety of tributyrin
Safety will be defined as the percent of patients who experienced serious adverse events.
Time frame
Up to visit 7 (approximately day 90)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Prabesh Kanel
Lead sponsor
University of Michigan
Sponsor institution
Farmer Family Foundation
Collaborator
Source ClinicalTrials.gov