Treatment of Dravet Syndrome With Fenfluramine (Expanded Access Protocol)

• Conditions: Dravet Syndrome

• Registration Number: NCT04437004
• Lead Sponsor: University of California, Los Angeles

Brief Summary

The purpose of this research study is to (1) provide access to fenfluramine for patients with intractable epilepsy associated with Dravet syndrome, and (2) evaluate the safety of fenfluramine.

Detailed Description

The purpose of this research study is to (1) provide access to fenfluramine for patients with intractable epilepsy associated with Dravet syndrome, and (2) evaluate the safety of fenfluramine.

Study Timeline

• Study First Submitted: 2020-02-21
• Status Verified: 2020-06
• Study First Submitted QC: 2020-06-16
• Last Update Submitted: 2020-06-16
• Study First Posted: 2020-06-18
• Last Update Posted: 2020-06-18

Recruitment & Eligibility

• Status: AVAILABLE
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Genetic diagnosis of Dravet syndrome with intractable seizures despite failing all available medications for seizures.

Exclusion Criteria

Not provided

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified

Trial Locations

Locations (1)

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States