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Clinical Trial Summary

This is a 2-part clinical trial to evaluate the safety, tolerability, pharmacokinetics, and efficacy of PRAX-114 in participants with essential tremor (ET). Part A is a randomized, double-blind, placebo-controlled, three-period, three-sequence, crossover design where participants will receive a single dose of 10 mg PRAX-114, 20 mg PRAX-114, and matching placebo. Part B is an open-label design where participants from Part A, after washout and confirmation of eligibility may elect to participate in Part B where all participants will receive 10 mg once every morning (QAM) for the first 14 days. Based on investigator judgement of the safety and tolerability, the dose for Days 15 to 28 could be increased to 20 mg QAM.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05387642
Study type Interventional
Source Praxis Precision Medicines
Contact
Status Withdrawn
Phase Phase 2
Start date April 5, 2022
Completion date June 30, 2022

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