ZX008 Expanded Access Protocol

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Brief Title

ZX008 Expanded Access Protocol

Official Title

ZX008 Expanded Access Protocol - Dravet Syndrome Treatment Plan

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.
    

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




Condition

Dravet Syndrome

Intervention

Fenfluramine Hydrochloride


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug





Eligibility Criteria

        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.
      

Gender

All

Ages

2 Years - N/A


Contacts

, , 



Administrative Informations


NCT ID

NCT03780127

Organization ID

ZX008-1800


Responsible Party

Sponsor

Study Sponsor

Zogenix, Inc.


Study Sponsor

, , 


Verification Date

April 2021