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ZX008 Expanded Access Protocol

Sponsor
Zogenix, Inc. (Industry)
Overall Status
Approved for marketing
CT.gov ID
NCT03780127
Collaborator
(none)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Fenfluramine Hydrochloride

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 Design

Study Type:
Expanded Access
Official Title:
ZX008 Expanded Access Protocol - Dravet Syndrome Treatment Plan

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years and Older
    Sexes Eligible for Study:
    All
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Zogenix, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zogenix, Inc.
    ClinicalTrials.gov Identifier:
    NCT03780127
    Other Study ID Numbers:
    • ZX008-1800
    First Posted:
    Dec 19, 2018
    Last Update Posted:
    Apr 27, 2021
    Last Verified:
    Apr 1, 2021
    Additional relevant MeSH terms:
    Epilepsies, Myoclonic
    Syndrome
    Fenfluramine

    Study Results

    No Results Posted as of Apr 27, 2021