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
Other Trials
Recruiting
Phase ii

DAZALS trial

Industry trial
In this study, an investigational oral drug named dazucorilant (also called CORT113176) is being studied in people living with ALS (also known as MND) to understand its safety (side effects) and to determine if dazucorilant can slow down the worsening of the disease. The effects of dazucorilant will be compared to the effects of a placebo. This study is sponsored by Corcept Therapeutics.
Read more
Recruiting
Phase ii

CARDINALS

Industry trial
The CARDINALS clinical research study is evaluating a study drug (Utreloxastat) to see if it can help slow ALS symptoms. Researchers will also test the safety and tolerability of the study drug and how the body responds to it. The study drug is a liquid that is swallowed 2 times a day.
Read more
Recruiting
Phase ii

AP101-02

Gesponsorde Trial
In this study we investigate the safety, tolerability, pharmacodynamics markers and pharmacokinetics (how a drug is absorbed and excreted) of AP-101 in patients with familial and sporadic amyotrophic lateral sclerosis (ALS). Currently, we are only looking for patients with familial ALS (caused by a SOD1 gene mutation) to participate in the study. This study is sponsored by AL-S Pharma.
Read more
Recruiting
Phase iii

ATLAS trial

Industry trial
Biogen is conducting a clinical trial to evaluate the efficacy and safety and of an investigational drug for adults who do not have any clinical signs or symptoms of Amyotrophic Lateral Sclerosis (ALS) (that definitely indicate the onset of ALS) but do carry a certain superoxide dismutase 1 (SOD1) gene variant.
Read more
Recruiting
Phase iii

FUSION trial

Industry trial
In this study we investigate the safety and efficacy of the study drug ‘ION363’ for the treatment of ALS caused by mutations in the FUS gene. About 1% to 5% of ALS cases are caused by FUS mutations.
Read more
Active
Phase iii

PHOENIX trial

Industry trial
Amylyx Pharmaceuticals Inc is conducting a phase 3 trial to determine the safety and efficacy of their compound 'AMX0035' for the treatment of ALS.
Read more
Completed
Phase iii

ADORE trial

Industry trial
Ferrer is conducting a phase 3 trial to evaluate the safety and potential efficacy of an investigational drug for people with Amyotrophic Lateral Sclerosis (ALS).
Read more