Phase 3

TUDCA-ALS

Investigator initiated trial

This trial will evaluate the efficacy of tauroursodeoxycholic acid (TUDCA) as add-on treatment for people with ALS.

TUDCA (tauroursodeoxycholic acid) is a small molecule that is being explored for its potential as a treatment for amyotrophic lateral sclerosis (ALS). TUDCA may decrease nerve cell death through its ability to act as an antioxidant that prevents toxic reactive oxygen from accumulating inside cells. There may also be an effect on immune function.

Study setup

TUDCA-ALS is a randomized, double-blind, placebo-controlled study. This means the effect of TUDCA is tested by comparing a group of patients that receive TUDCA to a group of patients receiving a placebo-drug. Patients will be randomized to one of two treatment arms. During the study, both the patient as the research team do not know who is receiving placebo or TUDCA. This will help researchers to assess potential side- and treatment effects of TUDCA.

TUDCA and the placebo capsules are ingested twice daily, 10-15 minutes after a meal. Patients will also be taking riluzole. The study duration is 18 months and clinical assessments during the trial phase will be performed every three months. This will allow measuring if the drug improves disease progression rate.

Would you like to participate?

Key eligibility criteria for people with ALS to participate, include:

  • Between 18 and 80 years old
  • Diagnosed with ALS
  • Disease duration ≤ 18 months
  • No swallowing difficulty
  • Forced vital capacity ≥70% of predicted values
  • On a stable dose of riluzole for at least 3 months
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