Trial · NCT07019922
A Clinical Trial of Elsunersen in Pediatric SCN2A-DEE to Assess Efficacy and Safety
NCT07019922, Phase 3, Recruiting, Praxis Precision Medicines
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Clinical Trial of Elsunersen in Pediatric SCN2A-DEE to Assess Efficacy and Safety. Trials, record NCT07019922. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07019922
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Clinical Trial of Elsunersen in Pediatric SCN2A-DEE to Assess Efficacy and Safety
- NCT number
- NCT07019922
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 40 participants, estimated
- Lead sponsor
- Praxis Precision Medicines
- Conditions
- Epileptic Encephalopathy, SCN2A Encephalopathy
- Interventions
- 1mg elsunersen, 0.5mg elsunersen
- First posted
- 2025-06-13
- Last updated
- 2026-08-03
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To assess the efficacy of elsunersen on seizure frequency in participants with early-onset SCN2A DEE | 24 weeks | Median percent change in monthly (28 days) motor seizure frequency from baseline to treatment after 24 weeks |
| Secondary | To assess secondary efficacy outcomes of elsunersen in participants with early-onset SCN2A DEE | 24 weeks | Responder rate - defined as a ≥50% reduction in monthly seizure frequency from baseline compared to treatment after 24 weeks |
| Secondary | To assess secondary efficacy outcomes of elsunersen in participants with early-onset SCN2A DEE | 24 weeks | Change in motor seizure-free days from baseline |
| Secondary | CGI-S change from baseline | 24 weeks | CGI-S assesses the clinician's impression of the participant's current illness state. The clinician should use his/her total clinical experience with this patient population and rate the current severity on a 7-point scale from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). |
| Secondary | CGI subdomain scores at each postdose time point | 24 weeks | Clinical Global Impression-Improvement (CGI-I) subdomains scores at each postdose time point |
| Secondary | CgGI-S from baseline | 24 weeks | Caregiver Global Impression-Severity (CgGI-S) at baseline compared to treatment after 24 weeks |
| Secondary | CgGI-I subdomain scores at each postdose time point | 24 weeks | Caregiver Global Impression-Improvement (CgGI I) subdomains scores at each postdose time point |
| Secondary | Sleep assessment scores from baseline | 24 weeks | Sleep assessment scores at baseline compared to each postdose time point |
| Secondary | To evaluate the safety and tolerability of elsunersen in participants with early-onset SCN2A DEE | 24 weeks | Incidence and severity of treatment-emergent adverse events (TEAEs) |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07019922
GET https://conductscience.org/api/trials/v1/NCT07019922/registered