The SOMCT02 trial has recruited its first patient on 8th August 2018 at the Hospital Clínic de Barcelona, under the leadership of Dr. Esteban Muñoz. This indicates that the trial is now fully underway.
SOMCT02 is a Phase 2a proof-of-concept and is designed as a randomized, double-blind, placebo-controlled, 2-arm, 27-week study to evaluate the safety and efficacy of SOM3355 in Huntington’s disease (HD) patients with chorea movements. A total of 30 patients is aimed to be recruited and improvement in their Total Maximal Chorea score will be measured as the primary efficacy endpoint. The study will also incorporate measurements in the different domains of the disease such as impression of change, functional capacity, gait and motor scores, as well as safety, as secondary endpoints.