The TUDCA-ALS phase 3 clinical trial is currently ongoing, with the final participant recruited in April 2022. The trial protocol has now been published in Frontiers in Neurology, and contains details on the study design, statistical plan, and trial management.
The study is organised by an international consortium of ALS specialists. 320 participants have been enrolled to a total of 25 participating centres across seven countries in Europe, and receive either TUDCA or a placebo.
Considering the phase 2 clinical trials testing TUDCA were promising as a treatment that can protect motor neurons, the TUDCA-ALS study will provide new answers on whether TUDCA can slow down disease progression in ALS.
Results of the trial are expected in late 2023.