A Clinical Trial of PRAX-114 in Participants With Essential Tremor
Status:
Recruiting
Trial end date:
2022-10-01
Target enrollment:
Participant gender:
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.