ZX008 Expanded Access Protocol

October 23, 2023 updated by: Zogenix, Inc.

ZX008 Expanded Access Protocol - Dravet Syndrome Treatment Plan

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.

Study Overview

Status

Approved for marketing

Conditions

Intervention / Treatment

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.

Study Type

Expanded Access

Expanded Access Type

  • Treatment IND/Protocol

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zogenix, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

December 14, 2018

First Submitted That Met QC Criteria

December 14, 2018

First Posted (Actual)

December 19, 2018

Study Record Updates

Last Update Posted (Actual)

October 24, 2023

Last Update Submitted That Met QC Criteria

October 23, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZX008-1800

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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