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NCT03936777CompletedPhase 3

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

An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy for Seizures in Patients With Rare Seizure Disorders Such as Epileptic Encephalopathies Including Dravet Syndrome and Lennox-Gastaut Syndrome

Source: ClinicalTrials.gov · Last updated 17 Nov 2025

Brief summary (registry, in English)

This is an international, multicenter, open-label, long-term safety study of ZX008 in subjects with Dravet syndrome, Lennox-Gastaut syndrome or epileptic encephalopathy

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
412 (actual)
First submitted
12 Apr 2019
Start date
22 Apr 2019
Primary completion date
8 May 2025
Lead sponsor
Zogenix, Inc.
Diseases
Epilepsy
NCT number
NCT03936777
EudraCT number
2019-001331-31

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 412
  • From 22 Apr 2019 to the primary completion date, 8 May 2025
  • 71 sites in 14 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Receiving monoamine oxidase inhibitors, serotonin agonists, serotonin antagonists, and serotonin reuptake inhibitors within 14 days of receiving ZX008

Other illness

  • Current cardiac valvulopathy or pulmonary hypertension that is clinically significant
  • Moderate or severe hepatic impairment

Who the study is looking for

  • Male or nonpregnant, nonlactating female
  • 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

Age in the registry: 2 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (71)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ep0215 301
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HeidelbergAustraliaUnknown status
Ep0215 302
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South BrisbaneAustraliaUnknown status
Ep0215 303
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WestmeadAustraliaUnknown status
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BrusselsBelgiumUnknown status
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EdegemBelgiumUnknown status
Ep0215 802
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JetteBelgiumUnknown status
Ep0215 202
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MontrealCanadaUnknown status
Ep0215 204
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TorontoCanadaUnknown status
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VancouverCanadaUnknown status
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BielefeldGermanyUnknown status
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Freiburg im BreisgauGermanyUnknown status
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JenaGermanyUnknown status
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KielGermanyUnknown status
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RadebergGermanyUnknown status
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VogtareuthGermanyUnknown status
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DianalundDenmarkUnknown status
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BarcelonaSpainUnknown status
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BarcelonaSpainUnknown status
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Esplugues de LlobregatSpainUnknown status
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MadridSpainUnknown status
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PamplonaSpainUnknown status
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BordeauxFranceUnknown status
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LilleFranceUnknown status
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MarseilleFranceUnknown status
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ParisFranceUnknown status
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ParisFranceUnknown status
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SalouëlFranceUnknown status
Ep0215 605
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BirminghamUnited KingdomUnknown status
Ep0215 601
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GlasgowUnited KingdomUnknown status
Ep0215 603
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LiverpoolUnited KingdomUnknown status
Ep0215 606
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LondonUnited KingdomUnknown status
Ep0215 602
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LondonUnited KingdomUnknown status
Ep0215 1201
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FlorenceItalyUnknown status
Ep0215 1204
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GenovaItalyUnknown status
Ep0215 1205
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MantuaItalyUnknown status
Ep0215 1207
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MilanItalyUnknown status
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RomaItalyUnknown status
Ep0215 1206
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RomaItalyUnknown status
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VeronaItalyUnknown status
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GuadalajaraMexicoUnknown status
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HeezeNetherlandsUnknown status
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ZwolleNetherlandsUnknown status
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BydgoszczPolandUnknown status
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KrakowPolandUnknown status
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GothenburgSwedenUnknown status
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AtlantaUnited StatesUnknown status
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AuroraUnited StatesUnknown status
Ep0215 140
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BethesdaUnited StatesUnknown status
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BostonUnited StatesUnknown status
Ep0215 110
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ChicagoUnited StatesUnknown status
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ClevelandUnited StatesUnknown status
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DallasUnited StatesUnknown status
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Fort WorthUnited StatesUnknown status
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Gulf BreezeUnited StatesUnknown status
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HackensackUnited StatesUnknown status
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HawthorneUnited StatesUnknown status
Ep0215 118
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LivingstonUnited StatesUnknown status
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Los AngelesUnited StatesUnknown status
Ep0215 124
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MemphisUnited StatesUnknown status
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MiamiUnited StatesUnknown status
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New YorkUnited StatesUnknown status
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OrlandoUnited StatesUnknown status
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RochesterUnited StatesUnknown status
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RosevilleUnited StatesUnknown status
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Salt Lake CityUnited StatesUnknown status
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San DiegoUnited StatesUnknown status
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San FranciscoUnited StatesUnknown status
Ep0215 119
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SeattleUnited StatesUnknown status
Ep0215 125
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TacomaUnited StatesUnknown status
Ep0215 107
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TucsonUnited StatesUnknown status
Ep0215 121
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Winter ParkUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.