A Study to Investigate the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) as an Adjunctive Therapy in Children and Adults With Lennox-Gastaut Syndrome
NCT ID: NCT03355209
Last Updated: 2025-07-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
296 participants
INTERVENTIONAL
2017-11-27
2024-05-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ZX008 0.2 or 0.8 mg/kg/day
Part 1: ZX008 is supplied as an oral solution. Subjects will be randomized to receive 1 of 2 doses of ZX008 0.2 mg/kg/day or 0.8 mg/kg/day.
ZX008 0.2 or 0.8 mg/kg/day
ZX008 drug product is an oral aqueous solution of fenfluramine hydrochloride. The product is sugar free and is intended to be compatible with a Ketogenic Diet.
Matching Placebo
Part 1: Matching ZX008 placebo is supplied as an oral solution.
Matching Placebo
Placebo will be administered twice a day (BID) in equally divided doses.
Open-Label
Part 2: ZX008 is supplied as an oral solution. Study medication will be administered twice a day (BID) in equally divided doses.
ZX008 0.2 or 0.8 mg/kg/day
ZX008 drug product is an oral aqueous solution of fenfluramine hydrochloride. The product is sugar free and is intended to be compatible with a Ketogenic Diet.
Interventions
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ZX008 0.2 or 0.8 mg/kg/day
ZX008 drug product is an oral aqueous solution of fenfluramine hydrochloride. The product is sugar free and is intended to be compatible with a Ketogenic Diet.
Matching Placebo
Placebo will be administered twice a day (BID) in equally divided doses.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis of Lennox-Gastaut syndrome, where seizures that result in drops are not completely controlled by current antiepileptic treatments.
* Onset of seizures at 11 years of age or younger.
* Abnormal cognitive development.
* Must be receiving at least 1 concomitant AED and up to 4 concomitant anti-epileptic treatments.
Exclusion Criteria
* History of hemiclonic seizures in the first year of life.
* Subject only has drop seizures in clusters, where individual seizures cannot be counted reliably.
* Pulmonary arterial hypertension.
* Current or past history of cardiovascular or cerebrovascular disease, such as cardiac valvulopathy, myocardial infarction or stroke.
* Receiving concomitant therapy with: centrally-acting anorectic agents; monoamineoxidase inhibitors; any centrally-acting compound with clinically appreciable amount of serotonin agonist or antagonist properties, including serotonin reuptake inhibition; atomoxetine, or other centrally-acting noradrenergic agonist; cyproheptadine.
* Taking felbamate for less than 1 year prior to screening and/or does not have stable liver function and hematology laboratory tests, and/or the dose has not been stable for at least 60 days prior to the Screening Visit.
* Currently receiving an investigational product.
* Institutionalized in a general nursing home (ie, in a facility that does not specialize in epilepsy care).
* A clinically significant condition, or has had clinically relevant symptoms or a clinically significant illness in the 4 weeks prior to the Screening Visit, other than epilepsy, that would negatively impact study participation, collection of study data, or pose a risk to the subject.
2 Years
35 Years
ALL
No
Sponsors
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Zogenix International Limited, Inc., a subsidiary of 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 Francisco, California, United States
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Aurora, Colorado, United States
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Washington D.C., District of Columbia, 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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Orlando, 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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Grand Rapids, Michigan, United States
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Royal Oak, Michigan, United States
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Rochester, Minnesota, United States
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Saint Paul, 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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Hartsdale, 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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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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York, Pennsylvania, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, 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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Brussels, , Belgium
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Brussels, , Belgium
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Edegem, , Belgium
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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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Bron, , 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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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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Bologna, , Italy
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Florence, , Italy
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Genova, , Italy
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Roma, , Italy
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Roma, , Italy
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Fukuoka, , Japan
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Niigata, , Japan
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Okayama, , Japan
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Osaka, , Japan
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Ōmura, , Japan
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Sapporo, , Japan
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Shinjuku-ku, , Japan
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Shizuoka, , Japan
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Guadalajara, , Mexico
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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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Mirasierra, , Spain
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Pamplona, , Spain
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Gothenburg, , Sweden
Countries
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References
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Knupp KG, Scheffer IE, Ceulemans B, Sullivan JE, Nickels KC, Lagae L, Guerrini R, Zuberi SM, Nabbout R, Riney K, Shore S, Agarwal A, Lock M, Farfel GM, Galer BS, Gammaitoni AR, Davis R, Gil-Nagel A. Efficacy and Safety of Fenfluramine for the Treatment of Seizures Associated With Lennox-Gastaut Syndrome: A Randomized Clinical Trial. JAMA Neurol. 2022 Jun 1;79(6):554-564. doi: 10.1001/jamaneurol.2022.0829.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan: Part 2 Cohort B-SAP
Document Type: Statistical Analysis Plan: Part 2 Cohort A-SAP
Document Type: Statistical Analysis Plan: Part 1 Cohort B-SAP
Document Type: Statistical Analysis Plan: Part 1 Cohort A-SAP
Other Identifiers
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2017-002628-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ZX008-1601
Identifier Type: -
Identifier Source: org_study_id
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