Ulixacaltamide Improves Daily Function in Patients With Essential Tremor
Topline data from two phase 3 trials evaluating ulixacaltamide in patients with essential tremor (ET) have been announced.
Ulixacaltamide is a highly selective small molecule T-type calcium channel inhibitor designed to block neuronal bursting in the cerebello-thalamo-cortical circuit linked to tremor activity.
The Essential3 phase 3 program (ClinicalTrials.gov Identifier: NCT06087276) consisted of 2 simultaneous trials. ET participants on no more than 1 stable ET medication were randomly assigned 2:1 to either Study 1 or Study 2.
Trial Design
Study 1 was a double-blind, parallel design, placebo-controlled trial. Participants were randomly assigned 1:1 to receive ulixacaltamide (n=199) or placebo (n=233) for 12 weeks.
The primary endpoint was the change from baseline to week 8 in Modified Activities of Daily Living 11 (mADL11) score.
Author summary: Ulixacaltamide improves daily function in ET patients.