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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05122650 | A Study To Assess the Safety and Efficacy of JZP385 in the Treatment of Adults With Moderate to Severe Essential Tremor (ET) | PHASE2 | COMPLETED | 420 | — | — | Dec 6, 2021 | May 30, 2024 | Jul 24, 2025 | 73 | United States, Germany +2 |
The TETRAS composite outcome score is the sum of modified items 1 - 11 of the TETRAS-ADL subscale and modified items 6 - 7 of the TETRAS-PS. The TETRAS-ADL subscale is a patient-rated scale administered by a trained interviewer that assesses the impact of tremor on day-to-day functioning, such as eating, drinking, dressing, and other fine motor skills. The TETRAS-PS is a clinical rating scale that quantifies tremor in the head, face voice, limbs and trunk. Items 6 (drawing an Archimedes spiral using left and right hands) and 7 (handwriting) of the TETRAS-PS evaluate the impact of upper limb tremor on performance. Each item from the modified subscales ranges from 0 - 3, with 0 representing normal or slightly abnormal and 3 representing severely abnormal. The sum of the 14 items provides the TETRAS composite outcome score, which ranges from 0 - 42, with higher scores representing more severe ET.
| Arm | Type | Description |
|---|---|---|
| 10 milligram (mg) JZP385 | EXPERIMENTAL | Participants will initially receive 5 mg/day from Day 1 through Day 7, and 10 mg/day starting on Day 8. |
| 20 mg JZP385 | EXPERIMENTAL | Participants will initially receive 5 mg/day from Day 1 through Day 7, 10 mg/day from Day 8 through Day 14, and 20 mg/day starting on Day 15. |
| 30 mg JZP385 | EXPERIMENTAL | Participants will initially receive 5 mg/day from Day 1 through Day 7, 10 mg/day from Day 8 through Day 14, 20 mg/day from Day 15 through Day 21, and 30 mg/day starting on Day 22. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo from Day 1. |
| Name | Type | Description |
|---|---|---|
| JZP385 | DRUG | JZP385 capsules will be administered orally (PO) once daily in the morning on an empty stomach for 12 weeks. |
| Placebo | OTHER | Placebo capsules will be administered orally (PO) once daily in the morning on an empty stomach for 12 weeks. |
Inclusion Criteria: 1. Participant must be 18 to 80 years of age inclusive, at the time of signing the informed consent. 2. Participants who are diagnosed with ET (including ET plus) according to the MDS Consensus Statement on the Classification of Tremors from the Task Force on Tremor of the Inter...