A Clinical Trial for Participants With DEE to Assess Efficacy, Safety, Tolerability, and PK of Relutrigine
← catalyst calendarNCT07010471 · readout ≤ 134 d
Sponsored by Praxis Precision Medicines (industry) · PRAX — their whole pipeline →.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
160estimated
Sites
11
Countries
Australia, Brazil, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-07-09 | actual | When the study began enrolling |
| Primary completion | Dec 2026 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Nov 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2025-06-08 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-04 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Developmental and Epileptic Encephalopathy 1
Interventions
- Drug: 1.0mg/kg/day PRAX-562 — also filed as relutrigine
- Drug: 1.5mg/kg/day PRAX-562
- Drug: Placebo
Primary outcome
what the primary-completion date above is the date OFTo assess the effect of relutrigine on seizure frequency in participants with DEEs compared to placebo
measured 16 weeks
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