A Study to Investigate the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Children and Adults With Epileptic Encephalopathy Including Dravet Syndrome and Lennox-Gastaut Syndrome
NCT ID: NCT03936777
Last Updated: 2025-11-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
412 participants
INTERVENTIONAL
2019-04-22
2025-05-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ZX008 (Fenfluramine Hydrochloride)
ZX008 is supplied as an open-label oral solution.Doses will include up to 0.8 mg/kg/day divided into 2 daily doses, up to a maximum of 30 mg/day (subjects taking concomitant STP will receive up to 0.5 mg/kg/day, up to a maximum of 20 mg/day) in a concentration of 2.5 mg/mL.
ZX008 (Fenfluramine Hydrochloride)
Fenfluramine hydrochloride provided in a concentration of 2.5 mg/mL.
Interventions
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ZX008 (Fenfluramine Hydrochloride)
Fenfluramine hydrochloride provided in a concentration of 2.5 mg/mL.
Eligibility Criteria
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Inclusion Criteria
* Satisfactory completion of a core study
* Has a rare seizure disorder, such as epileptic encephalopathy and has successfully completed another Zogenix-sponsored clinical trials with ZX008
* Subject's caregiver is willing and able to be compliant with study procedures, visit schedule and study drug accountability
Exclusion Criteria
* Moderate or severe hepatic impairment
* Receiving monoamine oxidase inhibitors, serotonin agonists, serotonin antagonists, and serotonin reuptake inhibitors within 14 days of receiving ZX008
2 Years
ALL
No
Sponsors
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Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
INDUSTRY
Zogenix, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Cares
Role: STUDY_DIRECTOR
001 844 599 2273
Locations
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Tucson, Arizona, United States
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Los Angeles, California, United States
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San Diego, California, United States
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San Francisco, California, United States
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Aurora, Colorado, United States
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Gulf Breeze, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Winter Park, Florida, United States
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Atlanta, Georgia, United States
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Chicago, Illinois, United States
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Bethesda, Maryland, United States
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Boston, Massachusetts, United States
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Rochester, Minnesota, United States
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Roseville, Minnesota, United States
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Hackensack, New Jersey, United States
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Livingston, New Jersey, United States
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Hawthorne, New York, United States
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New York, New York, United States
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Cleveland, Ohio, United States
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Memphis, Tennessee, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Salt Lake City, Utah, United States
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Seattle, Washington, United States
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Tacoma, Washington, United States
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Heidelberg, , Australia
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South Brisbane, , Australia
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Westmead, , Australia
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Brussels, , Belgium
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Edegem, , Belgium
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Jette, , Belgium
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Montreal, , Canada
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Toronto, , Canada
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Vancouver, , Canada
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Dianalund, , Denmark
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Bordeaux, , France
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Lille, , France
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Marseille, , France
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Paris, , France
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Paris, , France
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Salouël, , France
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Bielefeld, , Germany
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Freiburg im Breisgau, , Germany
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Jena, , Germany
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Kiel, , Germany
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Radeberg, , Germany
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Vogtareuth, , Germany
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Florence, , Italy
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Genova, , Italy
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Mantova, , Italy
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Milan, , Italy
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Roma, , Italy
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Roma, , Italy
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Verona, , Italy
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Guadalajara, , Mexico
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Heeze, , Netherlands
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Zwolle, , Netherlands
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Bydgoszcz, , Poland
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Krakow, , Poland
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Barcelona, , Spain
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Barcelona, , Spain
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Esplugues de Llobregat, , Spain
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Madrid, , Spain
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Pamplona, , Spain
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Gothenburg, , Sweden
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Birmingham, , United Kingdom
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Glasgow, , United Kingdom
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Liverpool, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ZX008-1900
Identifier Type: -
Identifier Source: org_study_id
2019-001331-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1309-4338
Identifier Type: OTHER
Identifier Source: secondary_id
2024-515680-61
Identifier Type: REGISTRY
Identifier Source: secondary_id
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