ZX008 Expanded Access Protocol

Zogenix

Status

Conditions: Dravet Syndrome

Treatments: Drug: Fenfluramine Hydrochloride

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT03780127

ZX008-1800

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

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.