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NCT05737784 · ClinicalTrials.gov registry record · Phase 1
A Clinical Trial of PRAX-222 in Pediatric Participants With Early Onset SCN2A Developmental and Epileptic Encephalopathy
A Phase 1 study of Epilepsy and SCN2A-DEE, sponsored by Praxis Precision Medicines.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 3
- Study locations
NCT05737784: Recruiting Phase 1 study of Epilepsy and SCN2A-DEE, sponsored by Praxis Precision Medicines.
NCT05737784 is a Phase 1 study of Epilepsy and SCN2A-DEE that is actively recruiting participants, run by Praxis Precision Medicines. The registered enrollment target is 60 participants, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (94% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05737784, a Phase 1 study of Epilepsy and SCN2A-DEE, is actively recruiting participants, sponsored by Praxis Precision Medicines.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 3
- Study locations
Study Summary
The goal of this trial is to learn about the effect of PRAX-222 in pediatric participants with early onset SCN2A developmental and epileptic encephalopathy (DEE), aged 2 to 18 years.
Primary Outcome
The number of participants with treatment-emergent adverse events will be reported by severity and preferred term.
Interventions
- DRUG PRAX-222 - Initial Dose
- DRUG PRAX-222 - Initial Ascending Doses
- DRUG PRAX-222 - Optional Ascending Doses
- DRUG PRAX-222 - Fixed Doses
- PROCEDURE Placebo
Study Locations (3)
Tennessee
- Le Bonheur Childrens Hospital - Memphis
Rio Grande do Sul
- Hospital de Clinicas de Porto Alegre - Porto Alegre
Other
- Praxis Research Site - São Paulo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2023-04-13 |
| Est. Completion | 2027-09 |
| Phase | Phase 1 |
What NCT05737784 shows while recruiting
NCT05737784 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (94% lower).
The record links to 2 conditions, with Epilepsy appearing as the primary indexed condition, and to 5 interventions - of which PRAX-222 - Initial Dose is the first listed.
NCT05737784 reports a single indexed study location in Tennessee, Rio Grande do Sul, Other.
Frequently Asked Questions
What is clinical trial NCT05737784 about?
NCT05737784 is a clinical study titled "A Clinical Trial of PRAX-222 in Pediatric Participants With Early Onset SCN2A Developmental and Epileptic Encephalopathy". The goal of this trial is to learn about the effect of PRAX-222 in pediatric participants with early onset SCN2A developmental and epileptic encephalopathy (DEE), aged 2 to 18 years.
What is the current status of trial NCT05737784?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2023-04-13. Estimated completion is 2027-09.
What conditions does trial NCT05737784 study?
This clinical trial studies the following conditions: Epilepsy, SCN2A-DEE.
What interventions are being tested in trial NCT05737784?
The interventions under investigation include: PRAX-222 - Initial Dose (DRUG), PRAX-222 - Initial Ascending Doses (DRUG), PRAX-222 - Optional Ascending Doses (DRUG), PRAX-222 - Fixed Doses (DRUG), Placebo (PROCEDURE).
Who is sponsoring clinical trial NCT05737784?
This trial is sponsored by Praxis Precision Medicines, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05737784 being conducted?
This trial has 3 study locations across Tennessee, Rio Grande do Sul. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05737784's enrollment target sits among peer trials
60 78th of 160 higher than 78 of 160 other Epilepsy trials
participants (enrollment target), bucketed by value
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