NCT05021978

A Clinical Trial of PRAX-944 in Participants With Essential Tremor

A Phase 2 Clinical Trial Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of PRAX-944 in Adults With Essential Tremor

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Praxis Precision Medicines · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Essential Tremor

Interventions

Type	Name	Description
DRUG	Part A: 20 and 40 mg PRAX-944	Once daily oral treatment
DRUG	Part B: 120 mg PRAX-944	Once daily oral treatment with titration
DRUG	Part B: 120 mg PRAX-944 and Placebo	Once daily oral treatment with titration followed by placebo

Timeline

• Start date: 2020-03-03
• Primary completion: 2022-03-24
• Completion: 2022-03-24
• First posted: 2021-08-26
• Last updated: 2024-03-01
• Results posted: 2024-03-01

Locations

9 sites across 3 countries: United States, Australia, New Zealand

Regulatory

• FDA-regulated drug study