Jeremy M Shefner, Ammar Al-Chalabi, Jinsy A Andrews, Adriano Chio, Mamede De Carvalho, Bettina M Cockroft, Philippe Corcia, Philippe Couratier, Merit E Cudkowicz, Angela Genge, Orla Hardiman, Terry Heiman-Patterson, Robert D Henderson, Caroline Ingre, Carlayne E Jackson, Wendy Johnston, Noah Lechtzin, Albert Ludolph, Nicholas J Maragakis, Timothy M Miller, Jesus S Mora Pardina, Susanne Petri, Zachary Simmons, Leonard H Van Den Berg, Lorne Zinman, Stuart Kupfer, Fady I Malik, Lisa Meng, Tyrell J Simkins, Jenny Wei, Andrew A Wolff, Stacy A Rudnicki
Objective : To determine the target population and optimize the study design of the phase 3 clinical trial evaluating reldesemtiv in participants with amyotrophic lateral sclerosis (ALS). Methods : We evaluated the phase 2 study of reldesemtiv, FORTITUDE-ALS, to inform eligibility criteria and design features that would increase trial efficiency and reduce participant burden of the phase 3 trial. Results : In FORTITUDE-ALS, the effect of reldesemtiv was particularly evident among participants in the intermediate- and fast-progressing tertiles for pre-study disease progression...
May 30, 2023: Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration