Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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APPROVED_FOR_MARKETING
EXPANDED_ACCESS
Brief Summary
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Detailed Description
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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.
Conditions
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Interventions
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Fenfluramine Hydrochloride
ZX008 drug product is an oral aqueous solution of fenfluramine hydrochloride. The product is sugar free and is intended to be compatible with KD.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 has valvulopathy.
* Patient is at risk for pulmonary hypertension.
* Patient exclusion will be at the sole discretion of the Sponsor.
2 Years
ALL
No
Sponsors
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Zogenix, Inc.
INDUSTRY
Responsible Party
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References
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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.
Other Identifiers
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ZX008-1800
Identifier Type: -
Identifier Source: org_study_id
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