Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06598449
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-13
Brief Title:
Assessment of Safety of the Use of Fenfluramine in Children with Dravet Syndrome Under 24 Months of Age
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Assessment of Safety of the Use of Fenfluramine in Children with Dravet Syndrome Under the Age of 24 Months
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Dravet syndrome is a genetic epilepsy associated with pathogenic variants in SCN1A that codes for Nav11 a protein necessary for sodium channels Children with Dravet syndrome classically present in the first year of life with prolonged seizures often hemiclonic and in the setting of fever or temperature changes such as getting in or out of bath water Many anti-seizure medications are sodium channel blockers and exacerbate seizures in this patient population This creates some limitations in medication choices for this patient population Recently fenfluramine was approved for use in Dravet syndrome for people 2 years and older Randomized studies demonstrated a 749 reduction of convulsive motor seizures compared to 192 in the placebo group Additionally 16 of children treated with fenfluramine were seizure free Fenfluramine is likely to be as effective in children under the age of 2 years The current study has proposed a treatment protocol to allow access to fenfluramine for children under 24 months of age
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None