Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06087276 | Essential 3 - Decentralized, Phase 3 Study Evaluating the Safety and Efficacy of Ulixacaltamide in Essential Tremor (ET) | PHASE3 | ENROLLING BY_INVITATION | 1,000 | — | — | Nov 2, 2023 | Dec 1, 2026 | Sep 30, 2025 | 1 | United States |
Modified Activities of Daily Living 11 (mADL11) is a composite sum of items 1 to 11 of the TETRAS-ADL subscale. The impact to each function is rated on a 5-point Likert scale from 0 to 4. Before calculating the total score, a scoring adjustment is applied to each item score. The modified score is calculated as the sum of all 11 items (with scoring adjustments) and ranges from 0 to 33 where larger values represent increased direct tremor impact to activities of daily living.
Modified Activities of Daily Living 11 (mADL11) is a composite sum of items 1 to 11 of the TETRAS-ADL subscale. The impact to each function is rated on a 5-point Likert scale from 0 to 4. Before calculating the total score, a scoring adjustment is applied to each item score. The modified score is calculated as the sum of all 11 items (with scoring adjustments) and ranges from 0 to 33 where larger values represent increased direct tremor impact to activities of daily living. Change in patient response will compare the proportion of patients in the ulixacaltamide and placebo arm who maintain response based on RW baseline established at Week 8 (Day 56) following randomized withdrawal.
The number of participants with Adverse Events (AE) will be reported by preferred term
| Arm | Type | Description |
|---|---|---|
| Parallel Design: ulixacaltamide arm | EXPERIMENTAL | Double-blind Part: Oral dosing, once daily in the morning with titration over 14 days to 60 mg ulixacaltamide: 7 days of 20 mg, 7 days of 40 mg, 70 days of 60 mg |
| Parallel Design: placebo arm | PLACEBO_COMPARATOR | Double-blind Part: Oral dosing, once daily in the morning: 84 days of placebo |
| Randomized Withdrawal | EXPERIMENTAL | Double-blind Part: Oral dosing, once daily in the morning with titration over 14 days to 60 mg ulixacaltamide: 7 days of 20 mg, 7 days of 40 mg, 42 days of 60 mg Randomized Withdrawal Part: Following double-blind part: 1:1 randomization to placebo or 60 mg ulixacaltamide for 28 days |
| Long-term Safety Study: Essential1 rollovers | EXPERIMENTAL | Open-label Part: Oral dosing, once daily in the morning up to 3 years 60 mg ulixacaltamide |
| Long-term Safety Study: Parallel Design and Randomized Withdrawal rollovers | EXPERIMENTAL | Open-label Part for patients previously on placebo: Oral dosing, once daily in the morning with titration over 14 days to 60 mg ulixacaltamide: 7 days of 20 mg, 7 days of 40 mg, up to 3 years 60 mg ulixacaltamide Open-label Part for patients previously on 60 mg ulixacaltamide: Oral dosing, once daily in the morning up to 3 years 60 mg ulixacaltamide |
| Long-term Safety Study: Direct Enrollment to LTSS Study | EXPERIMENTAL | Oral dosing, once daily in the morning with titration over 14 days to 60 mg ulixacaltamide: 7 days of 20 mg, 7 days of 40 mg, up to 3 years 60 mg ulixacaltamide |
| Name | Type | Description |
|---|---|---|
| 60 mg ulixacaltamide | DRUG | Once daily oral treatment with titration |
| Placebo | DRUG | Once daily oral treatment |
Inclusion Criteria for Study 1 PD and Study 2 RW: 1. Has a body mass index (BMI) at Screening of ≥18 kg/m2. 2. Has a clinical diagnosis of ET confirmed during screening and characterized by postural and action tremor. 3. If currently receiving medication prescribed for ET, must be on ≤1 medications...