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NCT04537832: ENVISION
Natural History Study of Infants and Children With Developmental and Epileptic Encephalopathies
trial testing No Intervention in Dravet Syndrome in 58 participants. Terminated before completion.
31 March 2023
Quick facts
| Lead sponsor | Encoded Therapeutics |
|---|---|
| Status | Terminated |
| Study type | OBSERVATIONAL |
| Enrollment | 58 |
| Start date | 18 January 2021 |
| Primary completion | 31 March 2023 |
| Estimated completion | 31 March 2023 |
| Sites | 16 locations across United Kingdom, United States, Australia, Spain |
Drugs / interventions tested
- No Intervention
Conditions studied
- Dravet Syndrome — all drugs for Dravet Syndrome →
Sponsor
Encoded Therapeutics — full company profile →
Who can join
Adults 6 Months to 60 Months, any sex, with Dravet Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a multicenter, prospective, 2-year observational study in infants and children with developmental and epileptic encephalopathies (DEEs). The DEE currently being investigated is SCN1A-positive Dravet Syndrome.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Clinical Trial Design for Disease-Modifying Therapies for Genetic Epilepsies.
Brock DC, Demarest S, Benke TA. · · 2021 · cited 10× · PMID 34595733 · DOI 10.1007/s13311-021-01123-5 -
Characterizing early behavioral and social-emotional problems in young children with SCN1A+ Dravet syndrome: Findings from the ENVISION prospective natural history study.
Scheffer IE, Perry MS, Sullivan J, Boronat S, et al · · 2026 · PMID 41627953 · DOI 10.1002/epi.70127 -
Cognitive stagnation and executive function deficits in young children with SCN1A+ Dravet syndrome: Detailed characterization of onset, progression, and impact in the ENVISION natural history study.
Sullivan J, Perry MS, Scheffer IE, Wheless J, et al · · 2026 · PMID 41251148 · DOI 10.1111/epi.70015
Verify or expand the search:
- PubMed search for NCT04537832
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of No Intervention
Trials testing the same drug.
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- NCT07521917 — Child Abuse and Neglect Awareness Training in Nursing Students · NA · not yet recruiting
- NCT07319832 — A Study of Teduglutide in Chinese Children and Teenagers With Short Bowel Syndrome · recruiting
- NCT07425574 — A Study to Learn How Stargardt-type Eye Conditions Progress in Children and Adults · recruiting
Other recruiting trials for Dravet Syndrome
Currently open trials in the same condition.
- NCT07251673 — Longitudinal Study of Phenotypic and Developmental Severity in Patients With Dravet Syndrome With SCN1A Gene Mutation · recruiting
- NCT06401538 — BMB-101 in Absence Epilepsy and DEE · Phase 2 · recruiting
- NCT06660394 — A Phase 3, Placebo-Controlled Study to Investigate LP352 in Children and Adults With Dravet Syndrome (DS) · Phase 3 · recruiting
- NCT06118255 — A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Fenfluramine (Hydrochloride) in Infants 1 Year to Less · Phase 3 · active not recruiting
- NCT06504511 — SCN1A Horizons A Natural History Study of SCN1A-related Epilepsies in the United Kingdom · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04537832 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Encoded Therapeutics
- Last refreshed: 12 June 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04537832.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing