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

Essential Tremor

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

Inclusion Criteria3

Male or females between the ages of 18 and 75 years
Clinical diagnosis of essential tremor (ET)
Stable dose of 1 tremor medication throughout the clinical trial, or no other tremor medications

Exclusion Criteria10

Clinical evidence of psychogenic tremor
History of other medical, neurological or psychiatric condition that may explain or
cause tremor
Prior magnetic resonance-guided focused ultrasound or surgical intervention for ET
such as deep brain stimulation or thalamotomy
Botulinum toxin injection for ET in the 6 months prior to Screening
Unwilling or unable to discontinue primidone
Unwilling or unable to refrain from alcohol 24 hours before and during the clinical trial
visits.
Any other significant disease, disorder or lab abnormalities that may either put the patient at risk due to participation in the clinical trial, may influence or confound the result of the clinical trial, or affect the patient’s ability to participate in the 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.