Treatment of Dravet Syndrome With Fenfluramine (Expanded Access Protocol)
Dravet
1 other identifier
expanded_access
N/A
1 country
1
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.
Trial Health
Trial Health Score
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1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2020
CompletedFirst Posted
Study publicly available on registry
June 18, 2020
CompletedApril 20, 2026
June 1, 2022
February 21, 2020
April 16, 2026
Conditions
Interventions
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.
Eligibility Criteria
You may qualify if:
- Genetic diagnosis of Dravet syndrome with intractable seizures despite failing all available medications for seizures.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California, Los Angeles
Los Angeles, California, 90095-1752, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- expanded access
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2020
First Posted
June 18, 2020
Last Updated
April 20, 2026
Record last verified: 2022-06