Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JZP385 · 1 trial · 1 indication
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...
JZP385 is an investigational small molecule being developed for the treatment of essential tremor, a neurological condition causing involuntary shaking. It is being studied in adults with moderate to severe essential tremor. The drug is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
JZP385 is being developed by Jazz Pharmaceuticals plc, a biopharmaceutical company traded on the NASDAQ under the ticker symbol JAZZ. The company is conducting clinical research to evaluate the safety and efficacy of JZP385 in patients with essential tremor.
JZP385 is in Phase 2 clinical development. A Phase 2 clinical trial has been completed to assess the safety and efficacy of JZP385 in adults with moderate to severe essential tremor. The drug remains investigational and has not received FDA approval.
JZP385 has one completed Phase 2 clinical trial registered as NCT05122650. This randomized, double-blind, placebo-controlled study enrolled 420 participants with essential tremor across the United States, Germany, Poland, and Spain. The trial included adults aged 18 years and older.
JZP385 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for the treatment of essential tremor. The completed Phase 2 trial evaluated its safety and efficacy, but the drug has not yet received regulatory approval for commercial use.