At a glance
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A Phase 2 Clinical Trial Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of PRAX-944 in Adults With Essential Tremor
In Brief
A Phase 2 clinical trial evaluating Part A: 20 and 40 mg PRAX-944, Part B: 120 mg PRAX-944, and 1 other intervention for Essential Tremor. Completed, enrolled 24 participants across 9 sites in 3 countries.
Detailed 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.
Study Details
Timeline
Interventions
Once daily oral treatment
Once daily oral treatment with titration
Once daily oral treatment with titration followed by placebo