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NCT05021991 · ClinicalTrials.gov registry record · Phase 2
A Clinical Trial of 2 Doses of PRAX-944 in Participants With Essential Tremor
A Phase 2 study, sponsored by Praxis Precision Medicines.
- Completed
- Registry status
- Phase 2
- Development phase
- 133
- Enrollment target
NCT05021991: Completed Phase 2 study, sponsored by Praxis Precision Medicines.
NCT05021991 is a Phase 2 study that has completed, run by Praxis Precision Medicines. The registered enrollment target is 133 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05021991, a Phase 2 study, has completed, sponsored by Praxis Precision Medicines.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 133 participants
- Enrollment target
Study Summary
This multi-center, randomized, double-blinded, placebo-controlled, dose-range-finding clinical trial (with an optional Extension comprised of an Extension Double-blind (DB) Lead in Period followed by an Extension Open-label (OL) Period) that will assess the efficacy, safety, and tolerability of PRAX 944 in participants aged 18 years or older who have a diagnosis of Essential Tremor (ET) and have had symptoms for at least 3 years.
Primary Outcome
The modified ADL is a composite sum of items 1 to 11 of the TETRAS-ADL subscale and items 6 and 7 on the TETRAS-PS. The impact to each function is rated on a 5-point Likert scale from 0 to 4. Before calculating the total score, a scoring adjustment is applied to each item score. The modified ADL score is calculated as the sum of all 13 items (with scoring adjustments) and ranges from 0 to 42 where larger values represent increased direct tremor impact to activities of daily living.
Interventions
- DRUG Placebo
- DRUG 100 mg PRAX-944
- DRUG 60 mg PRAX-944
- DRUG Flexibly dosed 20 mg to 100 mg PRAX-944
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 133 participants |
| Start Date | 2021-10-14 |
| Est. Completion | 2024-02-29 |
| Phase | Phase 2 |
What the finished NCT05021991 record still lists
NCT05021991 is an interventional study that assigns participants to a tested intervention. The registered 133 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT05021991 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05021991 about?
NCT05021991 is a clinical study titled "A Clinical Trial of 2 Doses of PRAX-944 in Participants With Essential Tremor". This multi-center, randomized, double-blinded, placebo-controlled, dose-range-finding clinical trial (with an optional Extension comprised of an Extension Double-blind (DB) Lead in Period followed by an Extension Open-label (OL) Period) that will assess the efficacy, safety, and tolerability of PRAX...
What is the current status of trial NCT05021991?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 133 participants. The study started on 2021-10-14. Estimated completion is 2024-02-29.
What interventions are being tested in trial NCT05021991?
The interventions under investigation include: Placebo (DRUG), 100 mg PRAX-944 (DRUG), 60 mg PRAX-944 (DRUG), Flexibly dosed 20 mg to 100 mg PRAX-944 (DRUG).
Who is sponsoring clinical trial NCT05021991?
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 NCT05021991's enrollment target sits among peer trials
133 538th of 2000 higher than 1,462 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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