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

NCT05387642 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2022-11-30

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • VP, Clinical Development · Praxis Precision Medicines

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-05
Primary Completion
2022-06-30
Completion
2022-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05387642 on ClinicalTrials.gov