ZX008 Expanded Access Protocol

ZX008 Expanded Access Protocol - Dravet Syndrome Treatment Plan

NCT03780127•Zogenix, Inc.

Summary

The treatment plan for this Expanded Access Protocol is for patients with Dravet syndrome who do not qualify for participation in one of the ongoing ZX008 clinical trials.

Detailed Description

The treatment plan consists of an up to 24-month Treatment Period. Access is via application by your health care provider and available at one of the Expanded Access treatment centers. The dose of ZX008 for the duration of the Treatment Period will range from 0.2 mg/kg/day to a maximum of 0.8 mg/kg/day, not to exceed a total daily dose of 30 mg/day; for patients concurrently being prescribed stiripentol, the maximum will be 0.5mg/kg/day, not to exceed a total daily dose of 20 mg/day. The fenfluramine US Expanded Access Program (US EAP) is available to full-time US Residents only. Participation in the US EAP is limited to patients currently residing in the US. Residency in the US must be for the duration of participation in the US EAP. Drug may not be shipped outside the US.

Eligibility

Age

2 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patient is male or female, age 2 years and older, inclusive as of Study Day 1.
•Patient is diagnosed with Dravet syndrome.
•Patient is experiencing convulsive seizures which are not controlled by current AEDs.
•Patient is receiving at least one AED and will remain on at least one AED for the duration of treatment.
•Patient has been approved for inclusion by Zogenix.

Exclusion Criteria

•Patient requires or starts using an unacceptable or contraindicated concomitant medication.
•Patient has valvulopathy.
•Patient is at risk for pulmonary hypertension.
•Patient exclusion will be at the sole discretion of the Sponsor.

Key Dates

Last Updated

October 24, 2023

Conditions

Dravet Syndrome

Interventions

Fenfluramine Hydrochloride

DRUG

A Clinical Study to Evaluate the Safety and Efficacy of ETX101 in Infants and Children With SCN1A-Positive Dravet Syndrome

NCT05419492

Dravet Syndrome

View study

RECRUITINGPHASE3

A Study of EPX-100 (Clemizole Hydrochloride) in Participants With Dravet Syndrome

NCT04462770

Dravet Syndrome

View study

RECRUITINGPHASE4

Assessment of Safety of the Use of Fenfluramine in Children With Dravet Syndrome Under 24 Months of Age

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 24, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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ZX008 Expanded Access Protocol

Inclusion Criteria

Exclusion Criteria

A Clinical Study to Evaluate the Safety and Efficacy of ETX101 in Infants and Children With SCN1A-Positive Dravet Syndrome

A Study of EPX-100 (Clemizole Hydrochloride) in Participants With Dravet Syndrome

Assessment of Safety of the Use of Fenfluramine in Children With Dravet Syndrome Under 24 Months of Age

A Study to Investigate the Transition of Children From 'Artisanal" Cannabidiol (CBD) to Epidiolex

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

Bioavailability of Stiripentol After Single Oral Dose of Capsule vs Suspension in Healthy Subjects (STILIQ)