NCT05021991

A Clinical Trial of 2 Doses of PRAX-944 in Participants With Essential Tremor

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose Range Finding Clinical Trial to Evaluate the Efficacy, Tolerability, and Safety of PRAX-944 in the Treatment of Adults With Essential Tremor

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 133 (actual)
• Sponsor: Praxis Precision Medicines · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This multi-center, randomized, double-blinded, placebo-controlled, dose-range-finding clinical trial (with an optional Extension comprised of an Extension Double-blind (DB) Lead in Period followed by an Extension Open-label (OL) Period) that will assess the efficacy, safety, and tolerability of PRAX 944 in participants aged 18 years or older who have a diagnosis of Essential Tremor (ET) and have had symptoms for at least 3 years.

Conditions

• Essential Tremor

Interventions

Type	Name	Description
DRUG	100 mg PRAX-944	Once daily oral treatment with titration
DRUG	60 mg PRAX-944	Once daily oral treatment with titration
DRUG	Placebo	Once daily oral treatment
DRUG	Flexibly dosed 20 mg to 100 mg PRAX-944	Once daily oral treatment

Timeline

• Start date: 2021-10-14
• Primary completion: 2023-02-09
• Completion: 2024-02-29
• First posted: 2021-08-26
• Last updated: 2024-03-13

Locations

39 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study