Evicenter
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Relutrigine

SCN2A- and SCN8A-related developmental and epileptic encephalopathies

Regulatory submission
NDA submitted in early 2026
Launch
Not announced
Last updated
72 sources

Clinical evidence

EMERALD

10 evidence topics · 3 sources

Objective
Location and study date
Countries recruiting in the protocol presentation
Country
“United States”
“Brazil”
“Australia”
Actual study start and completion dates

No evidence found.

Study design
Phase 3 study design

“randomized, multi-center, double-blind, placebo-controlled” (opens the source at this quote in a new tab)

Randomization ratio

“1:1” (opens the source at this quote in a new tab)

Eligibility criteria
Age at screening

“2-65 years of age” (opens the source at this quote in a new tab)

Treatment
Relutrigine starting dose

“1 mg/kg/day” (opens the source at this quote in a new tab)

Study outcomes
Rationale for using monthly motor seizure frequency as the primary endpoint
Primary outcome definition

“Change from baseline in monthly motor seizure frequency” (opens the source at this quote in a new tab)

Rationale for endpoint selection

No evidence found.

Statistical analysis description
Number of participants (Planned and analyzed)
Protocol presentation: planned enrollment

“enrolling ~160 eligible male and female participants aged 2-65 years with a diagnosis of DEE and onset of seizures <12 years old” (opens the source at this quote in a new tab)

EMERALD: enrollment update

“approximately 200 patients enrolled” (opens the source at this quote in a new tab)

Analyzed population

No evidence found.

Description of analysis sets

No evidence found.

Results
Participant disposition
EMERALD: development status

“The EMERALD study, which is evaluating relutrigine in patients with broad DEEs, has completed recruitment, with topline results anticipated in the fourth quarter of 2026.” (opens the source at this quote in a new tab)

Baseline characteristics

No evidence found.

Efficacy results

No evidence found.

Health-related quality of life and patient-reported outcomes

No evidence found.

Safety results

No evidence found.

Study limitations
Summary

The protocol presentation planned approximately 160 participants, while the subsequent corporate update reported approximately 200 enrolled. The study includes a broader DEE population than the indication addressed in this report. Recruitment completion and a planned fourth-quarter 2026 topline announcement do not establish efficacy or safety results, and the report contains no analyzed outcome dataset for EMERALD.