CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 59 enrolled
Drug / intervention
Tauroursodeoxycholic Acid +1 moredrug
Likely dose
Tauroursodeoxycholic Acid 250mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03423121
NCT03423121Phase 2Completed

A Phase 1/2 Trial of Tauroursodeoxycholic Acid Supplementation in Progressive MS Patients

Johns Hopkins University·interventional·Posted Feb 6, 2018·Updated May 3, 2023

In Brief

A Phase 2 clinical trial evaluating Tauroursodeoxycholic Acid and Placebo oral capsule for Progressive Multiple Sclerosis. Completed, enrolled 59 participants across 1 site.

Detailed Summary

This study aims to identify the safety and tolerability of bile acid supplementation in patients with progressive Multiple Sclerosis (MS). Participants will also be assessed for an impact of the bile acid on their immune system and gut microbiome. Half of the participants will receive the bile acid tauroursodeoxycholic acid (TUDCA) and half will receive placebo. The investigators believe participants who take TUDCA will have normalization of blood bile acid levels, a normalization of abnormal immune response and a normalization of the gut microbiome.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedFeb 6, 2018
Enrollment StartJun 19, 2018
Primary CompletionApr 28, 2022
Study CompletionJul 5, 2022
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 8.4 years ago

Interventions

Tauroursodeoxycholic Aciddrug

Participants will be given 1 gram of Tauroursodeoxycholic acid twice daily in the form of four 250mg capsules.

Placebo oral capsuledrug

Participants will be given four capsules of the placebo twice daily.