ZX008 Expanded Access Protocol

NCT03780127 | Unknown

• 1 other identifier: ZX008-1800
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Dravet Syndrome

Interventions

Fenfluramine Hydrochloride DRUG

ZX008 drug product is an oral aqueous solution of fenfluramine hydrochloride. The product is sugar free and is intended to be compatible with KD.

Also known as: ZX008

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patient requires or starts using an unacceptable or contraindicated concomitant medication.
• Patient has valvulopathy.
• Patient is at risk for pulmonary hypertension.

Sponsors & Collaborators

• Zogenix, Inc.: lead

Related Publications (1)

• Cross JH, Galer BS, Gil-Nagel A, Devinsky O, Ceulemans B, Lagae L, Schoonjans AS, Donner E, Wirrell E, Kothare S, Agarwal A, Lock M, Gammaitoni AR. Impact of fenfluramine on the expected SUDEP mortality rates in patients with Dravet syndrome. Seizure. 2021 Dec;93:154-159. doi: 10.1016/j.seizure.2021.10.024. Epub 2021 Nov 2.

  PMID: 34768178 DERIVED

MeSH Terms

Conditions

Epilepsies, Myoclonic

Interventions

Fenfluramine

Condition Hierarchy (Ancestors)

Epilepsy, Generalized; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes

Intervention Hierarchy (Ancestors)

Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2018
• First Posted: December 19, 2018
• Last Updated: October 24, 2023

Record last verified: 2023-10