A Phase III randomized withdrawal study presented at AAN 2026 demonstrated that ulixacaltamide maintained response in patients with essential tremor. The study met its primary endpoint, supporting the durability of its effect in individuals who responded during the initial lead-in phase.
Essential tremor is a progressive neurological disorder causing involuntary tremors that can significantly impact daily life and quality of care. Current treatments often provide limited relief, suffer from poor tolerability, or lack lasting efficacy. Ulixacaltamide, a selective T-type calcium channel modulator, is being developed through the Phase III Essential3 program to address these unmet needs.
The trial design involved adult patients with essential tremor receiving ulixacaltamide for an 8-week period. Responders were then randomized to either continue ulixacaltamide or switch to a placebo for 4 weeks to assess maintenance of response. The primary endpoint focused on the change in daily living activities.
While specific numerical results were not detailed in the initial summary, the study confirmed its primary endpoint was met. This positions ulixacaltamide as a potential new therapeutic option for managing the ongoing challenges of essential tremor, a condition with limited effective treatments.