A double-blind, randomized, multicenter, phase 2b study of the safety and efficacy of suvecaltamide in essential tremor.

INTRODUCTION

Effective treatments for essential tremor (ET) are needed. EveresT (NCT05122650) examined the efficacy and safety of suvecaltamide in patients with moderate to severe ET.

METHODS

In this phase 2 b, 12-week, double-blind, placebo-controlled, parallel-group, multicenter study, participants were equally randomized to once-daily placebo (n = 104) or suvecaltamide 10 mg (n = 105), 20 mg (n = 104), or 30 mg (n = 107). The primary endpoint was mean change from baseline to week 12 on The Essential Tremor Rating Assessment Scale (TETRAS) composite outcome score, which is a composite of the sum of modified items 1-11 of the TETRAS-Activities of Daily Living (TETRAS-ADL) subscale and modified items 6 and 7 of the TETRAS-Performance Subscale. The key secondary endpoint was the proportion of participants with ≥1-point improvement at week 12 on the Clinical Global Impression of Severity (CGI-S).

RESULTS

EveresT did not meet its primary endpoint; however, dose-related numerical improvements for suvecaltamide versus placebo were observed for the primary and multiple secondary endpoints, including TETRAS-ADL. At week 12, the mean difference between suvecaltamide 30 mg and placebo on the TETRAS composite score was -0.91 (95% confidence interval, -2.88, 1.06; P = 0.3626); 62.8% (52.9, 72.6) of participants improved ≥1 point at week 12 on the CGI-S with suvecaltamide 30 mg versus 50.0% (40.2, 59.8) with placebo (nominal P = 0.0771). Most common adverse effects with suvecaltamide 30 mg included dizziness (11.4%), paresthesia (8.6%), and insomnia, fatigue, somnolence, and worsening tremor (each 6.7%).

CONCLUSION

Suvecaltamide did not achieve statistically significant improvements on the primary or key secondary efficacy endpoints compared with placebo.