CLINICAL TRIAL

Tauroursodeoxycholic Acid for Multiple Sclerosis

1 Prior Treatment
Relapsed
Waitlist Available · 18+ · All Sexes · Baltimore, MD

This study is evaluating whether a bile acid may help improve symptoms of progressive multiple sclerosis.

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About the trial for Multiple Sclerosis

Eligible Conditions
Multiple Sclerosis, Chronic Progressive · Progressive Multiple Sclerosis (PMS) · Sclerosis · Multiple Sclerosis

Treatment Groups

This trial involves 2 different treatments. Tauroursodeoxycholic Acid is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Tauroursodeoxycholic Acid
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Placebo oral capsule
DRUG

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Multiple Sclerosis or one of the other 3 conditions listed above. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
I haven't had a relapse in the past 3 months. show original
A study has recently been published in the Lancet, which presents a new diagnostic criteria for progressive multiple sclerosis (MS), based on the Lublin criteria show original
The study found that patients with low levels of bile acids had a poorer prognosis than patients with normal levels show original
She has been on the same therapy for the past 6 months and is not expected to switch therapy in the next 6 months. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 16 weeks
Screening: ~3 weeks
Treatment: Varies
Reporting: 16 weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 16 weeks.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Tauroursodeoxycholic Acid will improve 1 primary outcome and 4 secondary outcomes in patients with Multiple Sclerosis. Measurement will happen over the course of Baseline to 16 weeks.

Quality of Life
BASELINE TO 16 WEEKS
Change in physical and mental health scores as assessed using the Multiple Sclerosis Quality of Life-54 (MSQOL-54) instrument. This 54-item instrument generates 12 subscales along with two summary scores, and two additional single-item measures. Two summary scores - physical health and mental health - are derived from a weighted combination of scale scores. Higher scores suggest a better quality of life.
BASELINE TO 16 WEEKS
Immunophenotyping
BASELINE TO 16 WEEKS
Change in flow cytometric assessments of peripheral blood mononuclear cells.
BASELINE TO 16 WEEKS
Metabolomics
BASELINE TO 16 WEEKS
Change in fasting bile acid levels in plasma.
BASELINE TO 16 WEEKS
Gut microbiota
BASELINE TO 16 WEEKS
Change in composition of the gut microbiota assessed using shot-gun metagenomic sequencing in first morning stool specimen.
BASELINE TO 16 WEEKS
Incidence of Treatment-related adverse events
16 WEEKS
Safety and tolerability will be assessed based on treatment-related adverse events in the two arms
16 WEEKS

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get multiple sclerosis a year in the United States?

About 1.2 million people in the United States are diagnosed with MS in any given year. Of all patients with MS, 0.85% have CIS. The incidence of clinically definite MS decreases with age. Approximately 0.8% of new patients with MS may have the progressive form of the disease. The incidence of RRMS, SPMS and PPMS is similar to that of the general population.

Anonymous Patient Answer

What are the signs of multiple sclerosis?

Signs in MS include symptoms such as weakness, unsteady walk, and numbness. These signs can start or worsen. A neurologist can help with diagnosis of MS.\n

Anonymous Patient Answer

What causes multiple sclerosis?

Current hypotheses include both genetic and environmental factors, including viruses, auto-antibody production, and immune dysregulation; and some evidence supports a role for viruses in causation of MS in an unknown proportion of cases.

Anonymous Patient Answer

Can multiple sclerosis be cured?

The data from this study indicate that MS cannot be cured yet. The improvement we saw in the majority of the patients was, though, clinically relevant (ES = 2.8).

Anonymous Patient Answer

What is multiple sclerosis?

Multiple sclerosis is an inflammatory and demyelinating autoimmune syndrome that often begins in young adulthood. The symptoms depend on which areas or parts of the brain are affected. A person with MS may not necessarily first experience muscle symptoms in any particular part of their body. Multiple sclerosis is a progressive disease. The goal of the treatment program is typically to return the patient to full function.\n

Anonymous Patient Answer

What are common treatments for multiple sclerosis?

There is significant patient variability in their response to therapy in MS and patients with different treatment regimens may have the same relapses. Current management requires a combination of drugs to reduce the frequency of relapses.

Anonymous Patient Answer

What is tauroursodeoxycholic acid?

The safety profile (measured, tolerability, effects on metabolic indicators and hepatic function) of UDCA is comparable to other commonly used bile acids. UDCA is also as effective as other bile acids in alleviating pruritic symptoms such as rosacea, perioral dermatitis, and atopic dermatitis. The safety data do not support the view that UDCA is harmful in overdose conditions.

Anonymous Patient Answer

Does tauroursodeoxycholic acid improve quality of life for those with multiple sclerosis?

There was no statistically significant difference in patient-reported MSQoL outcomes between the treatment and placebo arms. In clinical practice, patients and their clinicians should carefully consider the use of tauroursodeoxycholic acid for its potential safety and efficacy in MS.

Anonymous Patient Answer

What are the common side effects of tauroursodeoxycholic acid?

TUDACs side effects include diarrhea, gastrointestinal discomfort, nausea, abdominal or abdominal bloating, dizziness, headache, abdominal pain, and constipation. Patients are at risk of developing other adverse adverse impacts on daily life when exposed to TUDACs because of the unique interactions between these substances and the gut microbiome that exist in a dynamic equilibrium. The following interactions should be taken into consideration when selecting a TUDACs-based therapy regimen. ( 1) Age and sex: TUDACs can exacerbate some digestive disorders at lower doses in women.

Anonymous Patient Answer

Have there been other clinical trials involving tauroursodeoxycholic acid?

There are numerous reports about the use of tauroursodeoxy cholic acid in prevention of cholesterol, gallbladder stones and atherosclerosis but we could find no research evaluating its benefit in MS.

Anonymous Patient Answer

What is the average age someone gets multiple sclerosis?

The average age at diagnosis is 44-55 years old. The average age at onset is 29-36 years old. Those diagnosed later in life commonly have a younger onset. Patients diagnosed later at a median age of 58 may be at lower risk for disability. There appears to be a female predominance in multiple sclerosis.

Anonymous Patient Answer
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