ZX008 Expanded Access Protocol
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|ClinicalTrials.gov Identifier: NCT03780127|
Expanded Access Status : Available
First Posted : December 19, 2018
Last Update Posted : August 26, 2019
|Condition or disease||Intervention/treatment|
|Dravet Syndrome||Drug: Fenfluramine Hydrochloride|
The treatment plan consists of an up to 12-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|
|Official Title:||ZX008 Expanded Access Protocol - Dravet Syndrome Treatment Plan|
- Drug: 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 Name: ZX008
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03780127
|Contact: ZX008 Clinical Trials Information Desk||510-338-9968||ClinStudyInfo@zogenix.com|