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NCT05021978 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Praxis Precision Medicines.

Completed
Registry status
Phase 2
Development phase
24
Enrollment target

NCT05021978 is a Phase 2 study that has completed, run by Praxis Precision Medicines. The registered enrollment target is 24 participants.

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The verdict

NCT05021978, a Phase 2 study, has completed, sponsored by Praxis Precision Medicines.

COMPLETED
Registry status
Phase 2
Development phase
24 participants
Enrollment target

Study Summary

This is a 2-part clinical trial to evaluate the efficacy, safety, and tolerability of 40 and 120 mg oral PRAX-944 compared to placebo in the treatment of adults with essential tremor. Part A is designed to study the dose titration from 20 to 40 mg every morning (QAM) (ie, 2 weeks with 7 days at each dose level). Part B is designed to study the dose titration from 20 to up to 120 mg QAM with at least 14 days of dosing at the highest tolerated dose for each participant. Blood levels of PRAX-944 will also be measured throughout the trial and pharmacokinetics will be evaluated.

Interventions

  • DRUG Part A: 20 and 40 mg PRAX-944
  • DRUG Part B: 120 mg PRAX-944
  • DRUG Part B: 120 mg PRAX-944 and Placebo

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2020-03-03
Est. Completion 2022-03-24
Phase Phase 2

Sponsor

Praxis Precision Medicines

13 total trials

What the Registry Record Tells You About NCT05021978

The ClinicalTrials.gov registry entry for NCT05021978 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Praxis Precision Medicines, which has 13 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Part A: 20 and 40 mg PRAX-944 is the first listed.

NCT05021978 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT05021978 about?

NCT05021978 is a clinical study titled "A Clinical Trial of PRAX-944 in Participants With Essential Tremor". This is a 2-part clinical trial to evaluate the efficacy, safety, and tolerability of 40 and 120 mg oral PRAX-944 compared to placebo in the treatment of adults with essential tremor. Part A is designed to study the dose titration from 20 to 40 mg every morning (QAM) (ie, 2 weeks with 7 days at each...

What is the current status of trial NCT05021978?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2020-03-03. Estimated completion is 2022-03-24.

What interventions are being tested in trial NCT05021978?

The interventions under investigation include: Part A: 20 and 40 mg PRAX-944 (DRUG), Part B: 120 mg PRAX-944 (DRUG), Part B: 120 mg PRAX-944 and Placebo (DRUG).

Who is sponsoring clinical trial NCT05021978?

This trial is sponsored by Praxis Precision Medicines, which has 13 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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