Treatment of Dravet Syndrome With Fenfluramine (Expanded Access Protocol)

NCT ID: NCT04437004

Last Updated: 2020-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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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

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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.

Conditions

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Dravet Syndrome

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Fenfluramine Hydrochloride

Eligibility Criteria

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Inclusion Criteria

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

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Shaun Hussain, MD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of California, Los Angeles

Los Angeles, California, United States

Site Status AVAILABLE

Countries

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United States

Central Contacts

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Angela Martinez

Role: CONTACT

310-206-4037

Facility Contacts

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Shaun Hussain, MD

Role: primary

310-206-4037

Angela L. Martinez

Role: backup

310-206-4037

Other Identifiers

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ZX008-1800

Identifier Type: -

Identifier Source: org_study_id

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