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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
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.
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Layout table for eligibility information
Ages Eligible for Study:
2 Years to 35 Years (Child, Adult)
Sexes Eligible for Study:
Patient is male or female, age 2 to 35 years, 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.
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.