Essential Tremor Response Maintained with Ulixacaltamide
ULIXACALTAMIDE maintained response in essential tremor in a Phase III randomized withdrawal study at AAN 2026. The topline findings showed that the study met its primary endpoint, supporting durability of effect in patients who responded during the lead-in phase.
Phase III Essential Tremor Trial Design
Essential tremor is described in the abstract as a progressive neurologic disorder marked by involuntary tremor that can disrupt daily activities and quality of life. The investigators noted that currently available therapies may offer limited benefit, and that discontinuation remains common because of tolerability concerns, modest efficacy, or limited durability. Ulixacaltamide is being developed as a selective T-type calcium channel modulator for essential tremor within the Phase III Essential3 program.
Study 2 was designed as a randomized, double-blind, placebo-controlled withdrawal trial to assess maintenance of response and durability of effect. Adults aged 18–85 years with essential tremor symptoms for at least 3 years entered a blinded 8-week lead-in period and received ulixacaltamide hydrochloride 60 mg once daily after a 2-week titration. Patients taking background essential tremor medication were required to be on a stable dose for at least 28 days before screening.
Participants who met prespecified responder criteria were then re-randomized 1:1 either to continue ulixacaltamide or to switch to placebo for 4 weeks. The primary endpoint was maintenance of response at Day 84, defined as a 3-point or greater change in mADL11, based on TETRAS activities of daily living items 1–11 using a modified score. Secondary endpoints included disease improvement, patient and clinician global impression measures, and safety outcomes.
What the Ulixacaltamide Results Show
A total of 238 participants were enrolled. According to the abstract, the primary endpoint was met, although the numerical topline results were not included in the posted summary. That makes the central takeaway clear while leaving the magnitude of benefit, subgroup effects, and detailed safety findings still to be presented in fuller form.
The investigators state that Essential3 is the only ongoing Phase III program in essential tremor and describe Study 2 as the first registrational study to explore maintenance of effect after pharmacologic T-type calcium channel modulation with ulixacaltamide. On that basis, the findings position ulixacaltamide as a potential new option for addressing the persistent daily burden of essential tremor.
Reference
Farmer J et al. Maintenance of Response and Durability of Effect with Ulixacaltamide in Essential Tremor: Topline Phase 3 Results from Essential3 Study 2 (Randomized Withdrawal Study). Abstract 10.1212/WNL.0000000000217755. AAN Annual Meeting, 5-9 April, 2026.
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