Back to resultsTreatment of Dravet Syndrome With Fenfluramine (Expanded Access Protocol) (Dravet)
Primary Purpose
Dravet Syndrome
Status
Available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
Fenfluramine
Sponsored by
About this trial
This is an expanded access trial for Dravet Syndrome
Eligibility Criteria
Inclusion Criteria:
- Genetic diagnosis of Dravet syndrome with intractable seizures despite failing all available medications for seizures.
Sites / Locations
- University of California, Los Angeles
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT04437004
First Posted
February 21, 2020
Last Updated
June 16, 2020
Sponsor
University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT04437004
Brief Title
Treatment of Dravet Syndrome With Fenfluramine (Expanded Access Protocol)
Acronym
Dravet
Official Title
Treatment of Dravet Syndrome With Fenfluramine (Expanded Access Protocol)
Study Type
Expanded Access
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Available
Study Start Date
undefined (undefined)
Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dravet Syndrome
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Fenfluramine
Other Intervention Name(s)
Fenfluramine Hydrochloride
Intervention Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Eligibility Criteria
Inclusion Criteria:
Genetic diagnosis of Dravet syndrome with intractable seizures despite failing all available medications for seizures.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angela Martinez
Phone
310-206-4037
Email
angelamartinez@mednet.ucla.edu
Facility Information:
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1752
Country
United States
Individual Site Status
Available
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaun Hussain, MD
Phone
310-206-4037
First Name & Middle Initial & Last Name & Degree
Angela L. Martinez
Phone
310-206-4037
Email
angelamartinez@mednet.ucla.edu
12. IPD Sharing Statement
Learn more about this trial
Treatment of Dravet Syndrome With Fenfluramine (Expanded Access Protocol)
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