Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07010471 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

A Clinical Trial for Participants With DEE to Assess Efficacy, Safety, Tolerability, and PK of Relutrigine

Study acronym: EMERALD
StatusActive, Not Recruiting
PhasePhase 3
Started2025-07-09
View on ClinicalTrials.gov ↗

Amendment history

2026-07-31
Study Status, Contacts/Locations v5
Enrollment closed, study ongoing
Study sitesdetails revised at 11 of 11 sites
2026-05-08
Study Status, Contacts/Locations v4
Primary completion date2026-07→2026-12
Completion date2027-07→2027-11
Study sites5→11
2025-12-16
Study Status, Contacts/Locations v3
Study sites1→5
2025-10-01
Study Status v2
Primary completion date2026-04→2026-07
Completion date2027-02→2027-07
2025-07-31
Not Yet Recruiting→Recruiting Study Identification, Study Status, Outcome Measures, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-06→confirmed 2025-07-09
Secondary endpoints12 to 14 entries
ToAchieve explore>50% the effect of relutrigine on additional efficacy outcomesreduction in participantsmonthly withseizure DEEsfrequency from baseline To explore the effect of relutrigine on additional efficacy outcomesChange in participantsseizure-free withdays Clinical DEEsGlobal Impression-Severity questionnaire ToClinical exploreGlobal theImpression-Improvement effectquestionnaire Caregiver ofGlobal relutrigineImpression-Severity onquestionnaire Caregiver additionalGlobal efficacyImpression-Improvement outcomesquestionnaire Columbia-Suicide inSeverity participantsRating withScale DEEsques [...] [...]
Study sitesdetails revised at 1 of 1 site
Study title-13 characters
Randomized,A Double-BlindClinical StudyTrial infor Participants With DEE to Assess Efficacy, Safety, Tolerability, and PK of Relutrigine
2025-05-30
Original filing
A Phase 3, Randomized, Multi-Center, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Relutrigine in Participants with Developmental and Epileptic Encephalopathies Followed by an Open-Label Extension
Trial Details
NCT Number NCT07010471
Lead Sponsor Praxis Precision Medicines
Conditions Developmental and Epileptic Encephalopathy 1
Enrollment 160 participants
Start Date 2025-07-09
Primary Completion 2026-12 (estimated)
Study Completion 2027-11 (estimated)
Updated on ClinicalTrials.gov 2026-08-04