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Ursodoxicoltaurine

Clinical trials investigating Ursodoxicoltaurine are studying whether it can help slow disease progression in adults with serious neurological diseases. The trials focus on safety and efficacy in amyotrophic lateral sclerosis (ALS) and progressive supranuclear palsy (PSP), with outcomes measured by standard rating scales over time.

Table of Contents

Trial overview

The source data includes two Phase 3 clinical trials of Ursodoxicoltaurine, both listed as completed.[1][2]

These studies looked at adults with serious nervous system diseases: amyotrophic lateral sclerosis (ALS) and progressive supranuclear palsy (PSP).[1][2]

Amyotrophic lateral sclerosis study

The ALS trial was NCT05021536, titled “A study to investigate the safety and efficacy of AMX0035 in patients with Amyotrophic Lateral Sclerosis.”[1]

It was an interventional study, which means the researchers gave a study treatment and then measured the results.[1]

The study enrolled 664 people and compared AMX0035 with a placebo that matched the treatment.[1]

The main goal was to assess disease progression over 48 weeks in adult patients with ALS.[1]

Progressive supranuclear palsy study

The PSP trial was NCT06122662, titled “AMX0035 and Progressive Supranuclear Palsy.”[2]

This was also an interventional Phase 3 study, and it enrolled 910 participants.[2]

The study compared AMX0035 with a placebo matching AMX0035 to see whether it could change the rate of disease progression in PSP.[2]

The trial used the Progressive Supranuclear Palsy Rating Scale, called PSPRS, as the main way to measure change over time.[2]

Study design and comparison groups

Both trials used a placebo comparison, which helps researchers tell whether changes are likely due to the study treatment rather than chance.[1][2]

In the ALS study, the intervention list included AMX0035 as an oral product and a matching placebo oral powder in sachet form.[1]

In the PSP study, the intervention list included AMX0035 taken orally and a matching placebo.[2]

These details show that the trials were designed to compare outcomes between a treatment group and a control group in a fair way.[1][2]

Main outcomes measured

The primary outcome in the ALS study was change from baseline in the ALSFRS-R total score at Week 48, with adjustment for mortality.[1]

ALSFRS-R is a rating scale used to track daily function in people with ALS, so a change in this score helps show whether the disease is getting worse or staying more stable.[1]

The primary outcome in the PSP study was change from baseline in the total PSPRS score at Week 52.[2]

The source data also notes that different regional versions of the PSPRS endpoint were used to meet evidentiary requirements in the United States and outside the United States.[2]

In simple terms, the study team chose the main score used for analysis based on where the data were intended to support evidence requirements.[2]

Who participated

The ALS study included adult patients with ALS.[1]

The PSP study included people with progressive supranuclear palsy.[2]

The source data does not provide more detailed eligibility rules, such as age limits beyond adulthood or specific health requirements for joining the studies.[1][2]

What the trial data can tell patients

These trials were designed to test whether Ursodoxicoltaurine could help slow the worsening of ALS or PSP compared with placebo.[1][2]

Because both studies are listed as completed, the main research question has already been tested in these trial settings.[1][2]

The source data provided here focuses on study design, target diseases, and outcome measures, not on detailed trial results.[1][2]

Trial ID Phase Condition studied Status Enrollment
NCT05021536 Phase 3 Amyotrophic Lateral Sclerosis (ALS) Completed 664
NCT06122662 Phase 3 Progressive Supranuclear Palsy Completed 910

FAQ

  • What conditions are being studied in Ursodoxicoltaurine trials? The trials in the source data study amyotrophic lateral sclerosis (ALS) and progressive supranuclear palsy (PSP). Both are serious neurologic diseases that affect movement and daily function.
  • What phase are the Ursodoxicoltaurine trials? Both trials are Phase 3 studies. Phase 3 trials usually test whether a treatment works in a larger group of people and compare it with placebo.
  • Who took part in these trials? The studies enrolled adults with ALS or people with progressive supranuclear palsy. The source data does not give more detailed entry rules.
  • What are the trials trying to measure? The ALS trial measured change in the ALSFRS-R score, which is a scale for daily function in ALS. The PSP trial measured change in the PSP Rating Scale, which tracks disease severity over time.
  • Were these trials completed? Yes. Both studies in the source data are listed as completed. This means the planned treatment and follow-up were finished.

Ongoing Clinical Trials on Ursodoxicoltaurine

  • Study on the Effects of AMX0035 (Phenylbutyrate and Ursodoxicoltaurine) in Patients with Progressive Supranuclear Palsy

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Bulgaria France Germany Italy +4

  • Study on the Safety and Effectiveness of AMX0035 (Phenylbutyrate and Ursodoxicoltaurine) for Adults with Amyotrophic Lateral Sclerosis (ALS)

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Germany Ireland Italy The Netherlands +4

Glossary

  • Amyotrophic Lateral Sclerosis (ALS): A serious disease that affects nerve cells controlling muscle movement. It can cause weakness and loss of function over time.
  • Progressive Supranuclear Palsy (PSP): A brain disorder that can affect balance, eye movement, walking, and thinking. It usually gets worse over time.
  • Phase 3: A later stage of clinical research that tests whether a treatment works in a larger group of people and compares it with a control group.
  • Placebo: A look-alike treatment with no active study drug. It is used to compare results fairly.
  • Interventional study: A trial where researchers give a treatment and then measure what happens.
  • Enrollment: The number of people who joined the trial.
  • Primary outcome: The main result the researchers planned to measure to see if the treatment helped.
  • ALSFRS-R: A scale used in ALS trials to measure how well a person can do daily activities such as speaking, swallowing, and moving.
  • PSPRS: A rating scale used in PSP trials to measure how severe the disease is and how it changes over time.
  • Baseline: The starting point before treatment begins. Later results are compared with this starting level.
  • Week 48 / Week 52: Time points during the trial when researchers checked results after 48 or 52 weeks of follow-up.
  • Mortality: Death. Some trial results were adjusted for mortality, meaning death was taken into account when analyzing the data.

References