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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: Completed Phase 2 study, sponsored by Praxis Precision Medicines.
NCT05021978 is a Phase 2 study that has completed, run by Praxis Precision Medicines. The registered enrollment target is 24 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The TETRAS upper limb score is calculated as the sum of the 6 separate upper-limb maneuvers assessed by the clinician: forward-outstretched postural tremor \[right\], forward outstretched postural tremor \[left\], lateral wing-beating postural tremor \[right\], lateral wing-beating postural tremor \[left\], kinetic tremor \[right\], kinetic tremor \[left\], each on a 0 (no tremor) to 4 (maximum tremor) severity scale in 0.5-point increments. TETRAS Part 4 score for both upper limbs ranged from 0
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
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2020-03-03 |
| Est. Completion | 2022-03-24 |
| Phase | Phase 2 |
What the finished NCT05021978 record still lists
NCT05021978 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05021978's enrollment target sits among peer trials
24 1756th of 2000 higher than 217 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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