Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2025-12-29 @ 3:29 PM
Study NCT ID:
NCT04537832
Status:
TERMINATED
Last Update Posted:
2023-06-12
First Post:
2020-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Natural History Study of Infants and Children With Developmental and Epileptic Encephalopathies
Sponsor:
Encoded Therapeutics
Organization:
Study Overview
Official Title:
ENVISION: Natural History Study of Infants and Children With Developmental and Epileptic Encephalopathies
Status:
TERMINATED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The ENVISION study has generated a robust data set that shows consistency in the seizure and non-seizure manifestations of SCN1A+ Dravet syndrome.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENVISION
Brief Summary:
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.
Detailed Description:
This prospective, longitudinal, natural history master protocol has been designed to define the seizure, neurodevelopmental, and behavioral characteristics of SCN1A-positive Dravet Syndrome in infants and children between 6 and 60 months. It will also explore the impact of the disease on the participant's parent/caregiver quality of life (QoL) and healthcare resource utilization (HCRU).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: