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Treatment of Dravet Syndrome With Fenfluramine (Expanded Access Protocol)

Treatment of Dravet Syndrome With Fenfluramine (Expanded Access Protocol)

Status
APPROVED_FOR_MARKETING
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT04437004
Acronym
Dravet
Enrollment
Unknown
Registered
2020-06-18
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dravet Syndrome

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.

Interventions

DRUGFenfluramine

The treatment plan for this Expanded Access Protocol is for patients with Dravet syndrome who do not qualify for participation in one of the ongoing ZX008 (fenfluramine hydrochloride) clinical trials.

Sponsors

University of California, Los Angeles
Lead SponsorOTHER

Eligibility

Sex/Gender
ALL
Age
2 Years to No maximum

Inclusion criteria

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 21, 2026