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

Study Description

This multi-center, randomized, double-blind, placebo-controlled, dose-range-finding clinical trial will assess the efficacy, safety, and tolerability of PRAX-944 (the study drug) in participants aged 18 years or older who have a diagnosis of Essential Tremor and have had symptoms for at least 3 years. Participants will be randomized to receive either 56 days of PRAX-944 or a matching placebo (no study drug).

The clinical trial will consist of 3 study periods: 1. Screening/Baseline 2. Intervention, and 3. Safety Follow-up. The screening visit will last about 3 hours, but all other visits will last about 4-5 hours. The total number of visits will be 8 in-person visits and 4 phone calls over ~98 days of the study duration. and you will need to come to the study center at least 8 times over this period. The use of primidone is not allowed in this study. If the study doctor determines that you meet all of the requirements to be in this study, you will be randomly assigned (like drawing straws) on Day 1 to receive 1 of the following:

PRAX-944 (20 mg) PRAX-944 (60 mg) PRAX-944 (100 mg) Placebo (no drug) There will be compensation for participating in the research study to cover travel and parking costs. Study staff will be available via phone or email to answer any questions you may have if you are interested in participating in the trial or would like to learn more about the study.

Open Enrollment

Contact Name: Yasmeen Shabbir
Contact Phone: (904) 244-9856
Contact Email: yasmeen.shabbir@jax.ufl.edu

Investigators


Principal Investigator
Natalya V. Shneyder, M.D.
Neurology

Sub Investigator
Joseph D. Legacy, M.D.
Neurology