Trials / Terminated
TerminatedNCT04537832
Natural History Study of Infants and Children With Developmental and Epileptic Encephalopathies
ENVISION: Natural History Study of Infants and Children With Developmental and Epileptic Encephalopathies
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 58 (actual)
- Sponsor
- Encoded Therapeutics · Industry
- Sex
- All
- Age
- 6 Months – 60 Months
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | No Intervention | No Intervention |
Timeline
- Start date
- 2021-01-18
- Primary completion
- 2023-03-31
- Completion
- 2023-03-31
- First posted
- 2020-09-03
- Last updated
- 2023-06-12
Locations
16 sites across 4 countries: United States, Australia, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT04537832. Inclusion in this directory is not an endorsement.