Author: Chantal Kreloff

TUDCA-ALS, a phase III clinical trial to determine whether TUDCA (tauroursodeoxycholic acid) in combination with riluzole can slow progression of amyotrophic lateral sclerosis (ALS), has recruited 220 out of the 440 participants. 

Despite the global COVID-19 pandemic, the TUDCA-ALS trial continues to successfully recruit participants. We are pleased to announce that the trial has now recruited 50% of the participants.

The trial plans to recruit 440 participants across 7 countries in Europe: Italy, Germany, UK, France, Belgium, the Netherlands and Ireland. The study will investigate the use of TUDCA as an add-on treatment for ALS, also known as motor neurone disease (MND).

Professor Albanese, coordinator of the project, said

“I am excited to announce that, thanks to the continued hard work and dedication from all our clinical trial sites across the 7 countries, the TUDCA-ALS clinical trial has reached the halfway point in its recruitment. COVID-19 may have slowed down the anticipated speed of recruitment, but we are committed to continue recruiting participants into the TUDCA-ALS trial until we have reached the expected target. “

After the outbreak of COVID-19, the TUDCA-ALS consortium has introduced alternative procedures to continue servicing patients and ensure trial continuation, while at the same time reducing possible exposure to the risk of contagion. The TUDCA-ALS consortium is now committed to ensure that the 440-participant target is met as originally planned, despite the pandemic.

If you would like to learn more about the study and how to take part, please visit www.tudca.eu.

The recent announcement of the positive results from the phase 2 CENTAUR trial are exciting and promising for the TUDCA-ALS trial. 

The recent publication of the results from the CENTAUR Trial is of great interest to the TUDCA-ALS consortium. The CENTAUR trial was a phase 2/3 clinical trial looking at a drug named AMX0035, which is a combination of phenylbutyrate and tauroursodeoxycholic acid (TUDCA).

The CENTAUR trial followed 137 participants (89 taking AMX0035 and 48 taking a placebo) in the United States, for a period of 24 weeks. The results suggest that the treatment with AMX0035 has a clinically meaningful benefit and a favourable safety profile for people living with ALS.

The results of the CENTAUR trial are in line with those of a pilot phase 2 study, looking at the safety and efficacy of TUDCA on 60 people with ALS. This study suggests that TUDCA plays a role in delaying the progression of the disease, thus showing great promise for its use as an add-on treatment for ALS’  .

The currently ongoing TUDCA-ALS study is a phase 3 clinical trial supported by the European Commission, which aims to ascertain the long-term effectiveness and safety of TUDCA in people living with ALS. TUDCA-ALS will follow 440 participants in seven countries in Europe. Participants will be taking 1g of TUDCA or matched placebo twice a day, for a total 78 weeks (18 months).

The TUDCA-ALS consortium comments that the recent results from the CENTAUR trial confirm the great potential of TUDCA as an add-on treatment in people living with ALS. Given this recently evolved background, the TUDCA-ALS trial is now even more in the position to provide fundamental answers to ALS patients in Europe and worldwide.

If you would like to learn more about the study and how to take part, please visit https://www.tudca.eu/take-part/.

We would like to reassure you that despite the recent outbreak of COVID-19 epidemics across Europe, that all TUDCA-ALS trial activities are currently ongoing.

There continues to be regular shipments of the tablets that the participants are taking as part of the study (known as the Investigational Medicinal Product or IMP) as well as the shipments of the equipment and materials required to collect biological samples.

Despite the restrictions on travel within Italy, patients are permitted to travel in order to attend medical assessments.
We will of course provide further updates if the situation changes in the future.

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.