Treatment of Dravet Syndrome With Fenfluramine (Expanded Access Protocol) (Dravet)
April 16, 2026 updated by: University of California, Los Angeles
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.
Study Overview
Status
Approved for marketing
Conditions
Intervention / Treatment
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.
Study Type
Expanded Access
Expanded Access Type
- Treatment IND/Protocol
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Los Angeles, California, United States, 90095-1752
- University of California, Los Angeles
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Description
Inclusion Criteria:
- Genetic diagnosis of Dravet syndrome with intractable seizures despite failing all available medications for seizures.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
February 21, 2020
First Submitted That Met QC Criteria
June 16, 2020
First Posted (Actual)
June 18, 2020
Study Record Updates
Last Update Posted (Actual)
April 20, 2026
Last Update Submitted That Met QC Criteria
April 16, 2026
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZX008-1800
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dravet Syndrome
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University Health Network, TorontoZogenix, Inc.Terminated
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TakedaCompletedDravet Syndrome (DS)China, Canada, France, Hungary, Poland, United States, Spain, Greece, Australia, Brazil, Serbia, Germany, Italy, Japan, Latvia, Netherlands, Ukraine, Russian Federation
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University of Colorado, DenverUCB PharmaRecruitingDravet Syndrome (DS) | Children Under 2 YearsUnited States
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TakedaCompletedDravet Syndrome (DS) | Lennox-Gastaut Syndrome (LGS)Spain
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TakedaWithdrawnDravet Syndrome (DS) | Lennox-Gastaut Syndrome (LGS)
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TakedaTerminatedDravet Syndrome (DS) | Lennox-Gastaut Syndrome (LGS)Denmark
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Alexander RotenbergA-SynapticNot yet recruitingDravet Syndrome (DS) | Lennox-Gastaut Syndrome (LGS)United States
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TakedaTerminatedLennox Gastaut Syndrome (LGS) | Dravet Syndrome (DS)United States, China, Canada, France, Australia, Poland, Belgium, Spain, Hungary, Serbia, Greece, Japan, Latvia, Netherlands, Ukraine, Brazil, Mexico, Italy, Russia, Germany
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TakedaTerminatedEpilepsy | Dravet Syndrome (DS) | Lennox-Gastaut Syndrome (LGS)United States, Canada, Australia, Israel, Poland, Spain, China, Portugal
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Ionis Pharmaceuticals, Inc.RecruitingDravet SyndromeUnited States
Clinical Trials on Fenfluramine
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University of ChicagoUCB PharmaEnrolling by invitationLennox Gastaut Syndrome (LGS)United States
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UCB BIOSCIENCES, Inc.Not yet recruitingRett SyndromeUnited States, Hungary, Japan
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Zogenix, Inc.Active, not recruitingGeneralized Tonic Clonic Seizure | CDKL5 Deficiency Disorder | Epileptic Spasm | Refractory SeizuresUnited States, Austria, Belgium, Georgia, Germany, Ireland, Israel, Italy, Japan, Netherlands, Portugal, Spain, United Arab Emirates, United Kingdom
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Zogenix, Inc.Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.CompletedDravet Syndrome | Epileptic Encephalopathy | Lennox Gastaut SyndromeUnited States, Australia, Belgium, Canada, Denmark, France, Germany, Italy, Mexico, Netherlands, Poland, Spain, United Kingdom, Sweden
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Children's Hospital of Orange CountyRecruiting
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University of Colorado, DenverUCB PharmaRecruitingDravet Syndrome (DS) | Children Under 2 YearsUnited States
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The University of Texas Health Science Center,...Not yet recruitingDravet SyndromeUnited States
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UCB BIOSCIENCES, Inc.Active, not recruitingDravet SyndromeUnited States, Belgium, Germany, Italy, United Kingdom
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Zogenix International Limited, Inc., a subsidiary...CompletedDravet SyndromeUnited States, France, United Kingdom, Canada, Germany, Netherlands, Spain