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Calcium Channel Blocker

PRAX-944 for Essential Tremor (Essential1 Trial)

Phase 2
Waitlist Available
Research Sponsored by Praxis Precision Medicines
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 56 days
Awards & highlights

Essential1 Trial Summary

This trial will test a new medication for people with essential tremor, to see if it is effective and safe.

Eligible Conditions
  • Essential Tremor

Essential1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~56 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 56 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline to Day 56 on the modified ADL
Secondary outcome measures
CGI-I scores at Days 14, 28, and 42
Change from baseline to Day 42 on the TETRAS-PS total score
Change from baseline to Day 56 on the Clinical Global Impression-Severity (CGI-S)
+13 more
Other outcome measures
Incidence of AEs by preferred term

Side effects data

From 2022 Phase 2 trial • 24 Patients • NCT05021978
57%
Dizziness
43%
Headache
14%
Asthenopia
14%
Thirst
14%
Psychomotor hyperactivity
14%
Faeces hard
14%
Nausea
14%
Anxiety
14%
Essential tremor
14%
Initial Insomnia
14%
Dyspnoea
14%
Throat irritation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part A: PRAX-944 20mg to 40mg Open-Label Titration (OLT)
Part B: PRAX-944 20mg to 120mg OLT
Part B: Placebo RWD
Part B: PRAX-944 120mg Randomized Withdrawal Phase (RWD)

Essential1 Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Regimen 2Experimental Treatment4 Interventions
Double-blind Part: Oral dosing, once daily in the morning with titration over 56 days to 60 mg PRAX-944: 7 days of 5 mg, 7 days of 10 mg, 7 days of 20 mg, 7 days of 40 mg, 28 days of 60 mg Extension Part: Double-blind Lead-in: Oral dosing, once daily in the morning with titration over 43 days to 100 mg PRAX-944: 7 days of 80 mg, 36 days of 100 mg Extension Part: Open-label Flexible PRAX-944 Dosing: Oral dosing, once daily in the morning of 20 mg to 100 mg PRAX-944 for 469 days Crossover Part: Following double-blind lead-in/open-label: 1:1 randomization to placebo or stable dose of PRAX-944 for 21 days followed by cross-over to either placebo or PRAX-944 oral dosing, once daily in the morning with titration over 7 days (3 days at 20 mg, 4 days at 40 mg) to 60 mg (14 days) before returning to open-label part.
Group II: Regimen 1Experimental Treatment4 Interventions
Double-blind Part: Oral dosing, once daily in the morning with titration over 56 days to 100 mg PRAX-944: 7 days of 5 mg, 7 days of 10 mg, 7 days of 20 mg, 7 days of 40 mg, 7 days of 60 mg, 7 days of 80 mg, 14 days of 100 mg Extension Part: Double-blind Lead-in: Oral dosing, once daily in the morning over 43 days: 100 mg PRAX-944 Extension Part: Open-label Flexible PRAX-944 Dosing: Oral dosing, once daily in the morning of 20 mg to 100 mg PRAX-944 for 469 days Crossover Part: Following double-blind lead-in/open-label: 1:1 randomization to placebo or stable dose of PRAX-944 for 21 days followed by cross-over to either placebo or PRAX-944 oral dosing, once daily in the morning with titration over 7 days (3 days at 20 mg, 4 days at 40 mg) to 60 mg (14 days) before returning to open-label part.
Group III: Regimen 3Placebo Group4 Interventions
Double-blind Part: Oral dosing, once daily in the morning: 56 days of placebo Extension Part: Double-blind Lead-in: Oral dosing, once daily in the morning with titration over 43 days to 100 mg PRAX-944: 7 days of 5 mg, 7 days of 10 mg, 7 days of 20 mg, 7 days of 40 mg, 7 days of 60 mg, 7 days of 80 mg, 14 days of 100 mg Extension Part: Open-label Flexible PRAX-944 Dosing: Oral dosing, once daily in the morning of 20 mg to 100 mg PRAX-944 for 469 days Crossover Part: Following double-blind lead-in/open-label: 1:1 randomization to placebo or stable dose of PRAX-944 for 21 days followed by cross-over to either placebo or PRAX-944 oral dosing, once daily in the morning with titration over 7 days (3 days at 20 mg, 4 days at 40 mg) to 60 mg (14 days) before returning to open-label part.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
100 mg PRAX-944
2021
Completed Phase 2
~140
60 mg PRAX-944
2021
Completed Phase 2
~140
Flexibly dosed 20 mg to 100 mg PRAX-944
2021
Completed Phase 2
~140
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Praxis Precision MedicinesLead Sponsor
9 Previous Clinical Trials
1,046 Total Patients Enrolled
3 Trials studying Essential Tremor
624 Patients Enrolled for Essential Tremor
VP, Clinical DevelopmentStudy DirectorPraxis Precision Medicines
7 Previous Clinical Trials
690 Total Patients Enrolled
2 Trials studying Essential Tremor
24 Patients Enrolled for Essential Tremor
Director, Clinical DevelopmentStudy DirectorPraxis Precision Medicines
2 Previous Clinical Trials
600 Total Patients Enrolled
1 Trials studying Essential Tremor
600 Patients Enrolled for Essential Tremor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Flexibly dosed 20 mg to 100 mg PRAX-944 a safe intervention for human subjects?

"Our evaluation of Flexibly dosed 20 mg to 100 mg PRAX-944's safety score is 2 due to the limited data regarding its efficacy, even though there is some clinical evidence supporting its security."

Answered by AI

Are there any vacancies available to participants in this research study?

"As mentioned on clinicaltrials.gov, this medical trial is no longer accepting participants. The study was initially published on October 14th 2021 and most recently updated on November 28th 2022. However, 51 other trials are still open for enrollment at the moment."

Answered by AI

How many healthcare facilities are carrying out this trial?

"35 clinical trial sites are currently running this study, with locations ranging from Aurora to Louisville and Birmingham. It is advised that individuals select the closest centre to minimise travel requirements if they decide to enrol in the program."

Answered by AI

What objectives are researchers expecting to achieve through this trial?

"Praxis Precision Medicines, the clinical trial sponsor, indicates that Adverse Events (AE) is their primary outcome. This will be assessed over a period of 56 days and further measurements taken to record Clinical Global Impression-Improvement (CGI-I) score at Day 56, Change from baseline to Day 56 on the TETRAS-Performance Subscale (PS) total score, and Change from baseline to Day 56 on the TETRAS-upper limb (UL) score."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
Alabama
Florida
How old are they?
65+
18 - 65
What site did they apply to?
Praxis Research Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
1

Why did patients apply to this trial?

Saw ad on Facebook. Medication and Focused Ultrasound have failed to help me.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

Recent research and studies
clinicaltrials.govStudy
A Clinical Trial of 2 Doses of PRAX-944 in Participants With Essential Tremor
2021. "A Clinical Trial of 2 Doses of PRAX-944 in Participants With Essential Tremor". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05021991.
~38 spots leftby Apr 2025
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