NCT05387642

A Clinical Trial of PRAX-114 in Participants With Essential Tremor

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial to Explore the Safety, Tolerability, Pharmacokinetics, and Efficacy of PRAX-114 in the Treatment of Adults With Essential Tremor

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (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 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.

Conditions

• Essential Tremor

Interventions

Type	Name	Description
DRUG	10 mg PRAX-114, 20 mg PRAX-114, and Placebo	Single dose with a washout period between doses
DRUG	10 mg PRAX-114 or 20 mg PRAX-114	Once daily oral treatment for 28 days

Timeline

• Start date: 2022-04-05
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2022-05-24
• Last updated: 2022-11-30

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study