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
Sponsor: Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
This PHASE3 trial investigates Dravet Syndrome and Epileptic Encephalopathy and is currently completed. Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. leads this study, which shows 23 recorded versions since 2019 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Status Flow
Change History
23 versions recorded-
Dec 2025 — Present [monthly]
Completed PHASE3
-
Sep 2025 — Dec 2025 [monthly]
Completed PHASE3
-
Jul 2025 — Sep 2025 [monthly]
Completed PHASE3
Status: Active Not Recruiting → Completed
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Mar 2025 — Jul 2025 [monthly]
Active Not Recruiting PHASE3
-
Sep 2024 — Mar 2025 [monthly]
Active Not Recruiting PHASE3
▶ Show 18 earlier versions
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Aug 2024 — Sep 2024 [monthly]
Active Not Recruiting PHASE3
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Jul 2024 — Aug 2024 [monthly]
Active Not Recruiting PHASE3
-
Jun 2024 — Jul 2024 [monthly]
Active Not Recruiting PHASE3
-
May 2024 — Jun 2024 [monthly]
Active Not Recruiting PHASE3
-
Apr 2024 — May 2024 [monthly]
Active Not Recruiting PHASE3
-
Feb 2024 — Apr 2024 [monthly]
Active Not Recruiting PHASE3
-
Jan 2024 — Feb 2024 [monthly]
Active Not Recruiting PHASE3
-
Oct 2023 — Jan 2024 [monthly]
Active Not Recruiting PHASE3
-
May 2023 — Oct 2023 [monthly]
Active Not Recruiting PHASE3
-
Feb 2023 — May 2023 [monthly]
Active Not Recruiting PHASE3
-
Dec 2022 — Feb 2023 [monthly]
Active Not Recruiting PHASE3
Status: Enrolling By Invitation → Active Not Recruiting
-
Jul 2022 — Dec 2022 [monthly]
Enrolling By Invitation PHASE3
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Sep 2021 — Jul 2022 [monthly]
Enrolling By Invitation PHASE3
-
Jan 2021 — Sep 2021 [monthly]
Enrolling By Invitation PHASE3
-
Oct 2020 — Jan 2021 [monthly]
Enrolling By Invitation PHASE3
-
Feb 2020 — Oct 2020 [monthly]
Enrolling By Invitation PHASE3
-
Jul 2019 — Feb 2020 [monthly]
Enrolling By Invitation PHASE3
-
Jun 2019 — Jul 2019 [monthly]
Enrolling By Invitation PHASE3
First recorded
Apr 2019
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
- Zogenix, Inc.
For direct contact, visit the study record on ClinicalTrials.gov .