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Clinical Trial Details — Status: Available

Administrative data

NCT number NCT04437004
Other study ID # ZX008-1800
Secondary ID
Status Available
Phase
First received
Last updated

Study information

Verified date June 2020
Source University of California, Los Angeles
Contact Angela Martinez
Phone 310-206-4037
Email angelamartinez@mednet.ucla.edu
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 2 Years and older
Eligibility Inclusion Criteria:

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Fenfluramine
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.

Locations

Country Name City State
United States University of California, Los Angeles Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

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