NCT03780127

ZX008 Expanded Access Protocol

ZX008 Expanded Access Protocol - Dravet Syndrome Treatment Plan

• Status: Approved For Marketing
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Zogenix, Inc. · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: —

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.

Conditions

• Dravet Syndrome

Interventions

Type	Name	Description
DRUG	Fenfluramine Hydrochloride	ZX008 drug product is an oral aqueous solution of fenfluramine hydrochloride. The product is sugar free and is intended to be compatible with KD.

Timeline

• First posted: 2018-12-19
• Last updated: 2023-10-24