NCT03467113 is a Phase 1 clinical trial of ZX008 0.2 to 0.8 mg/kg/day in Dravet Syndrome, sponsored by Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc..

Who is sponsoring NCT03467113?

NCT03467113 is sponsored by Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc..

What drugs are being tested in NCT03467113?

Interventions in NCT03467113: ZX008 0.2 to 0.8 mg/kg/day, Cannabidiol.

What condition does NCT03467113 study?

NCT03467113 studies Dravet Syndrome, Lennox Gastaut Syndrome.

Is NCT03467113 still recruiting?

NCT03467113 is currently completed. Last updated 1 December 2023.

Last reviewed 2023-12-01 · How we verify

NCT03467113

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Assess the Safety and Tolerability of ZX008 in Children and Young Adults With Dravet Syndrome or Lennox Gastaut Syndrome Currently Taking Cannabidiol

Completed Phase 1 Last updated 1 December 2023

What this trial tests

Phase 1 trial testing ZX008 0.2 to 0.8 mg/kg/day in Dravet Syndrome in 9 participants. Completed in 24 June 2020.

Timeline

19 January 2018

Primary endpoint
24 June 2020

24 June 2020

Quick facts

Lead sponsor	Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	9
Start date	19 January 2018
Primary completion	24 June 2020
Estimated completion	24 June 2020
Sites	2 locations across United States

Drugs / interventions tested

ZX008 0.2 to 0.8 mg/kg/day — full drug profile →
Cannabidiol (CANNABIDIOL) — full drug profile →

Conditions studied

Dravet Syndrome — all drugs for Dravet Syndrome →
Lennox Gastaut Syndrome — all drugs for Lennox Gastaut Syndrome →

Sponsor

Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. — full company profile →

Who can join

Adults 2 to 18, any sex, with Dravet Syndrome or Lennox Gastaut Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is an open label study to evaluate the safety of ZX008 (fenfluramine) in patients with Dravet syndrome (DS) or Lennox Gastaut syndrome (LGS) who are being administered cannabidiol (CBD).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Medical Cannabis in Pediatric Oncology: Friend or Foe?
Malach M, Kovalchuk I, Kovalchuk O. · · 2022 · cited 8× · PMID 35337156 · DOI 10.3390/ph15030359

Verify or expand the search:

Other recruiting trials for Dravet Syndrome

Currently open trials in the same condition.

NCT07251673 — Longitudinal Study of Phenotypic and Developmental Severity in Patients With Dravet Syndrome With SCN1A Gene Mutation · recruiting
NCT06401538 — BMB-101 in Absence Epilepsy and DEE · Phase 2 · recruiting
NCT06660394 — A Phase 3, Placebo-Controlled Study to Investigate LP352 in Children and Adults With Dravet Syndrome (DS) · Phase 3 · recruiting
NCT06118255 — A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Fenfluramine (Hydrochloride) in Infants 1 Year to Less · Phase 3 · active not recruiting
NCT06504511 — SCN1A Horizons A Natural History Study of SCN1A-related Epilepsies in the United Kingdom · recruiting

Other Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. trials

Trials by the same sponsor.

NCT03355209 — A Study to Investigate the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) as an Adjunctive Therapy in Childre · Phase 3 · completed
NCT03299842 — A Study to Assess the Usability of the Embrace Seizure Detection Watch in Children and Young Adults With Dravet Syndrome · Phase 3 · terminated
NCT02926898 — A 2-Part Study to Investigate the Dose-Ranging Safety and Pharmacokinetics, Followed by the Efficacy and Safety of ZX008 · Phase 3 · completed
NCT02823145 — An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride HCl) Oral Solution in · Phase 3 · completed
NCT02682927 — A Trial of Two Fixed Doses of ZX008 (Fenfluramine HCl) in Children and Young Adults With Dravet Syndrome · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03467113 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
Last refreshed: 1 December 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03467113.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing