Status:
APPROVED_FOR_MARKETING
ZX008 Expanded Access Protocol
Lead Sponsor:
Zogenix, Inc.
Conditions:
Dravet Syndrome
Eligibility:
All Genders
2+ years
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 ZX0...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03780127
Last Update
October 24 2023
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