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NCT03936777 · ClinicalTrials.gov registry record · Phase 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
A Phase 3 study of Dravet Syndrome and Lennox Gastaut Syndrome, sponsored by Zogenix.
- Completed
- Registry status
- Phase 3
- Development phase
- 412
- Enrollment target
- 20
- Study locations
NCT03936777: Completed Phase 3 study of Dravet Syndrome and Lennox Gastaut Syndrome, sponsored by Zogenix.
NCT03936777 is a Phase 3 study of Dravet Syndrome and Lennox Gastaut Syndrome that has completed, run by Zogenix. The registered enrollment target is 412 participants, above the 76-participant average among 12 other Dravet Syndrome trials with a reported enrollment target (442% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03936777, a Phase 3 study of Dravet Syndrome and Lennox Gastaut Syndrome, has completed, sponsored by Zogenix.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 412 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is an international, multicenter, open-label, long-term safety study of ZX008 in subjects with Dravet syndrome, Lennox-Gastaut syndrome or epileptic encephalopathy
Primary Outcome
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (i
Conditions Studied
Interventions
- DRUG ZX008 (Fenfluramine Hydrochloride)
Study Locations (20)
Florida
- Ep0215 115 - Gulf Breeze
- Ep0215 104 - Miami
- Ep0215 141 - Orlando
- Ep0215 121 - Winter Park
California
- Ep0215 144 - Los Angeles
- Ep0215 108 - San Diego
- Ep0215 101 - San Francisco
Minnesota
- Ep0215 109 - Rochester
- Ep0215 132 - Roseville
New Jersey
- Ep0215 105 - Hackensack
- Ep0215 118 - Livingston
New York
- Ep0215 150 - Hawthorne
- Ep0215 142 - New York
Arizona
- Ep0215 107 - Tucson
Colorado
- Ep0215 103 - Aurora
Georgia
- Ep0215 117 - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 412 participants |
| Start Date | 2019-04-22 |
| Est. Completion | 2025-05-08 |
| Phase | Phase 3 |
What the finished NCT03936777 record still lists
NCT03936777 is an interventional study that assigns participants to a tested intervention. The registered 412 participants enrollment target is mid-sized for trials with a published cap, above the 76-participant average among 12 other Dravet Syndrome trials with a reported enrollment target (442% higher).
The record links to 3 conditions, with Dravet Syndrome appearing as the primary indexed condition, and to 1 intervention - of which ZX008 (Fenfluramine Hydrochloride) is the first listed.
NCT03936777 names 20 study sites across 12 states, led by Florida, California, Minnesota.
Frequently Asked Questions
What is clinical trial NCT03936777 about?
NCT03936777 is a clinical study titled "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". This is an international, multicenter, open-label, long-term safety study of ZX008 in subjects with Dravet syndrome, Lennox-Gastaut syndrome or epileptic encephalopathy
What is the current status of trial NCT03936777?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 412 participants. The study started on 2019-04-22. Estimated completion is 2025-05-08.
What conditions does trial NCT03936777 study?
This clinical trial studies the following conditions: Dravet Syndrome, Lennox Gastaut Syndrome, Epileptic Encephalopathy.
What interventions are being tested in trial NCT03936777?
The interventions under investigation include: ZX008 (Fenfluramine Hydrochloride) (DRUG).
Who is sponsoring clinical trial NCT03936777?
This trial is sponsored by Zogenix, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03936777 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03936777's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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