RecruitingPhase 2ACTRN12619001052123

A Clinical Trial to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of PRAX-944 in Essential Tremor

A Phase 2 Clinical Trial Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of PRAX-944 in Adults with Essential Tremor


Sponsor

Praxis Precision Medicines

Enrollment

12 participants

Start Date

Mar 3, 2020

Study Type

Interventional

Conditions

Summary

This is Part A of a 2-part, Phase 2, Clinical Trial Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of PRAX-944 in Adults with Essential Tremor. Each participant will complete 3 study periods: Screening, Treatment Period (21 or 28 days) and Safety Follow-up.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 75 Yearss

Plain Language Summary

Simplified for easier understanding

Essential tremor is a neurological condition that causes involuntary shaking, most often in the hands and arms. It can make everyday tasks like writing, eating, or holding a cup difficult. While some medications exist to help manage tremor, they don't work well for everyone and can have side effects. PRAX-944 is a new investigational drug being tested to see if it can reduce tremor more effectively. This Phase 2 trial tests the safety, tolerability, and effectiveness of PRAX-944 over a 3–4 week treatment period. Participants will attend clinic visits during a screening period, the treatment period, and a safety follow-up period. Blood samples will be taken to understand how the drug moves through the body. You may be eligible if you are aged 18–75 with a confirmed diagnosis of essential tremor, either taking a stable dose of one tremor medication or no tremor medications at all. People with other neurological conditions that could cause tremor, those who have had brain surgery or deep brain stimulation for tremor, or those unable to stop taking primidone are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PRAX-944 20mg orally once a day for 7 days and 40mg orally once a day for 7 days (total of 14 days consecutively) Study drug adherence will be monitored by a compliance application and verified by

PRAX-944 20mg orally once a day for 7 days and 40mg orally once a day for 7 days (total of 14 days consecutively) Study drug adherence will be monitored by a compliance application and verified by unused product return.


Locations(1)

Christchurch, New Zealand

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