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NCT03780127 Clinical Trial

ZX008 Expanded Access Protocol

Dravet Syndrome Clinical Trial

Official title:
ZX008 Expanded Access Protocol - Dravet Syndrome Treatment Plan

Clinical Trial Details — Status: Approved for marketing

Administrative data
NCT number NCT03780127
Other study ID # ZX008-1800
Secondary ID
Status Approved for marketing
Phase
First received
Last updated

Study information
Verified date October 2023
Source UCB Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Approved for marketing
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 2 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Zogenix, Inc.
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