Final Participant Randomised to the TUDCA-ALS trial

The Phase III TUDCA-ALS trial to determine whether tauroursodeoxycholic acid (TUDCA) in combination with riluzole can slow progression of amyotrophic lateral sclerosis, has admitted its final participant to the trial randomization phase.

As with many clinical trials, the global COVID-19 pandemic has created challenges with recruitment to the TUDCA-ALS trial across the seven participating European countries. Following consultation with statisticians and advice from the trial Independent Ethics Board, the consortium revised the enrolment target to 320 participants. The revised target was exceeded, with the final participant entering the randomisation phase in February 2022, bringing the total number of participants to 334 out of 404 patients screened.

Professor Albert Albanese, co-ordinator of the project said

“The TUDCA-ALS trial partners had to balance the need to recruit a sufficient number of participants against the risk of continued disruption caused by COVID-19 that would have greatly increased the cost and further delayed the trial outcome. Our statisticians have full confidence that the number of participants is sufficient to detect a statistically significant drug effect and we look forward to obtaining the study results as they emerge.”

“We thank the staff across the many participating clinics for their hard work and commitment in the face of the many challenges presented by the pandemic. We are also immensely grateful to the ALS patients who have so generously agreed to take part in the study and adapted to changes made in the trial protocol.”

The final participant will complete the study phase in August 2023 with top line results anticipated by end of 2023. Participants have been recruited across seven European countries: Italy, Germany, United Kingdom, France, Belgium, Ireland and the Netherlands. For more details of the study, please visit