20
Participants
Start Date
May 31, 2019
Primary Completion Date
November 25, 2021
Study Completion Date
July 19, 2024
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.
Massachusetts General Hospital, Boston
Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
INDUSTRY
Elizabeth Anne Thiele
OTHER