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Fenfluramine in Children With Dravet Syndrome Under 24 Months
NCT06598449Phase 4
Key facts
- Status
- Recruiting
- Start
- Oct 2024
- Primary completion
- Dec 2026
- Countries
- 1
- Sponsor
- University of Colorado Denver
- Modality
- Small Molecules
- Drugs
- fenfluramine
- Conditions
- Dravet syndrome
01
Overview
Phase 4, open-label, single-arm trial of fenfluramine in Dravet syndrome, sponsored by University of Colorado Denver. Primary endpoint: Percentage of participants that have at least one adverse event at 12 months. Started Oct 2024; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Fenfluramine
Clear, cherry flavored oral solution of fenfluramine
03
Who it enrols
Children aged 12 to 23 months with Dravet syndrome and a known or presumed pathogenic SCN1A variant, who have failed at least one non-sodium channel blocker anti-seizure medication.
04
Endpoints
Primary
Percentage of participants that have at least one adverse event
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