TUDCA study
Recruiting
TUDCA study (“Safety and efficacy of tauroursodeoxycholic acid (TUDCA) as add-on treatment in patients affected by amyotrophic lateral sclerosis (ALS)”), supported by Horizon 2020 project.
This phase 3 study aims to investigate the effect of taurodeoxycholic acid (TUDCA) on disease progression in patients with ALS. TUDCA is a bile acid with neuroprotective effects on motor nerve cells. TUDCA, after ingestion, is absorbed into the bloodstream, but can also reach the brain because it can pass through the blood brain barrier. TUDCA has few side effects. In a small phase 2 study, there seemed to be an effect of this drug on the functional decline (measured by the ALSFRS-R) of ALS patients. Therefore, it is hoped that a beneficial effect on disease progression will be demonstrated in this study.
In the study, a dose of 2 x 1000 mg per day will be compared to placebo, with a ratio of 1:1. Patients will be followed up for 18 months. To participate, the disease must not be too advanced: patients must have been ill for up to 18 months, swallowing function must be normal, and lung function (FVC) must be ≥ 70%. The study is taking place in more than 20 centers in Europe. Approximately 440 patients will be asked to participate. In Belgium, UZ Leuven is participating.
Detailed information and the list of inclusion and exclusion criteria can be found at:
clinicaltrials.gov/ct2/show/NCT03800524
and more information about the project at:
www.tudca.eu/
