A Clinical Trial of PRAX-944 in Participants With Essential Tremor
Summary
This is a 2-part clinical trial to evaluate the efficacy, safety, and tolerability of 40 and 120 mg oral PRAX-944 compared to placebo in the treatment of adults with essential tremor. Part A is designed to study the dose titration from 20 to 40 mg every morning (QAM) (ie, 2 weeks with 7 days at each dose level). Part B is designed to study the dose titration from 20 to up to 120 mg QAM with at least 14 days of dosing at the highest tolerated dose for each participant. Blood levels of PRAX-944 will also be measured throughout the trial and pharmacokinetics will be evaluated.
Timeline
- Start
- 2020-03-03
- Primary completion
- 2022-03-24
- Completion
- 2022-03-24
Outcome
Met primary endpoint
registry analysis (other test); Part A: PRAX-944 20mg to 40mg OLT; p = 0.0028; Mixed Models Analysis; note: Change from baseline to Day 14 in TETRAS UL score NCT05021978 ↗
registry LEAST_SQUARES_MEAN Part A: PRAX-944 20mg to 40mg OLT: Change from baseline to Day 14: -2.912 (-4.2779 to -1.5466) Scores on a scale NCT05021978 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ulixacaltamide | Small molecule | 40 mg | Oral |
| Subject | ulixacaltamide | Small molecule | 120 mg | Oral |