Treatment of Sunflower Syndrome With ZX008 (Fenfluramine Hydrochloride) in Children and Young Adults (Ages 4-25).

PHASE3CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

May 31, 2019

Primary Completion Date

November 25, 2021

Study Completion Date

July 19, 2024

Conditions
Photosensitive Epilepsy
Interventions
DRUG

Fenfluramine Hydrochloride

Fenfluramine Hydrochloride will be supplied to the treatment group as an oral solution in a concentration of 2.5 mg/mL. Subjects will receive their daily dose of Fenfluramine Hydrochloride in two doses (one in the morning and one in the evening). After a four week baseline, subjects that meet enrollment criteria will enter a titration period. The starting dose will be 0.2 mg/kg/day for the first 14 days. The dose will be increased every 2 weeks as tolerated by 0.2 mg/kg/day, to a maximum dose of 0.7 mg/kg/day, or a total maximum dose of 26 mg/day. The subject will remain on a dose of 0.7 mg/kg/day, 26 mg/day, or maximum tolerated daily dose through the end of the core study period.

Trial Locations (1)

02114

Massachusetts General Hospital, Boston

All Listed Sponsors
collaborator

Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.

INDUSTRY

lead

Elizabeth Anne Thiele

OTHER

NCT03790137 - Treatment of Sunflower Syndrome With ZX008 (Fenfluramine Hydrochloride) in Children and Young Adults (Ages 4-25). | Biotech Hunter | Biotech Hunter