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NCT04537832: ENVISION

Natural History Study of Infants and Children With Developmental and Epileptic Encephalopathies

Terminated Last updated 12 June 2023
What this trial tests

trial testing No Intervention in Dravet Syndrome in 58 participants. Terminated before completion.

Timeline
18 January 2021
Primary endpoint
31 March 2023
31 March 2023

Quick facts

Lead sponsorEncoded Therapeutics
StatusTerminated
Study typeOBSERVATIONAL
Enrollment58
Start date18 January 2021
Primary completion31 March 2023
Estimated completion31 March 2023
Sites16 locations across United Kingdom, United States, Australia, Spain

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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
  3. 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

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Other trials of No Intervention

Trials testing the same drug.

Other recruiting trials for Dravet Syndrome

Currently open trials in the same condition.

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Data sources for this page

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