TUDCA-ALS, a phase III clinical trial to determine whether TUDCA (Tauroursodeoxycholic Acid) in combination with riluzole can slow progression of ALS has recruited its first study participant.

The trial plans to recruit 440 participants across 7 countries; Italy, Germany, UK, France, Belgium, the Netherlands and Ireland and will investigate a new drug treatment for amyotrophic lateral sclerosis (ALS), also known as motor neurone disease (MND), has recruited its first participant in Italy.

The study is organised by the TUDCA-ALS Consortium formed by ten EU partner organisations, led by the research group of Prof. Alberto Albanese, Head of Neurology at Humanitas Mirasole Spa, Italy and is funded by a € 5.6 million funding grant from the European Commission Horizon 2020 Programme.

Professor Albanese says “I am excited to announce that the TUDCA-ALS clinical trial has recruited its first participant in Italy and am looking forward to the trial rolling out across the European network of participating centres in the coming months.”

The aim of the trial is to determine whether the drug TUDCA (Tauroursodeoxycholic Acid) in combination with riluzole can slow disease progression.

TUDCA is a molecule that helps to protect motor neurons by camouflaging a stress chemical released at the start of a process that results in cell death. It is already used to treat diabetes and certain liver conditions by increasing the expression of insulin-degrading enzyme. Its function as treatment that can protect the motor neurons is however still in the developmental stages.

An initial pilot study on 60 people with ALS showed that TUDCA significantly delayed the degeneration of motor neurons by about one third, allowing for longer survival of people living with the disease.