Essential 3 - Decentralized, Phase 3 Study Evaluating the Safety and Efficacy of Ulixacaltamide in Essential Tremor (ET)
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Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Triple · Treatment
Enrollment
1,000estimated
Sites
1
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-11-02 | actual | When the study began enrolling |
| Primary completion | 2025-10-10 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jul 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2023-10-17 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-16 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Essential Tremor
Interventions
- Drug: 60 mg ulixacaltamide
- Drug: Placebo
Primary outcomes
what the primary-completion date above is the date OFParallel Design: Change from Baseline (CFB) to Week 8 (Day 56) on mADL11 score
measured 8 weeks (56 days)
Randomized Withdrawal: The proportion of participants that maintain response, as defined by change in mADL11 score, following randomized withdrawal
measured 12 weeks (84 days)
Long-term Safety Study: Number of participants with Adverse Events (AE) and their severity.
measured Up to 3 years
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