20
Participants
Start Date
October 20, 2022
Primary Completion Date
February 20, 2025
Study Completion Date
June 20, 2025
Fenfluramine
"Administration of fenfluramine. Fenfluramine treatment dose: Between 0.2 and 0.7 mg/kg/day if no concomitant Stiripentol (STP), maximum dose: 40 mg/day \[or 0.5 mg/kg/day, maximum 30 mg/day, for subjects taking concomitant STP\]. Dosing will be started with 0.1mg/day per one week, then 0.2mg/kg/day per one week, then as investigator clinical decision-making, up to 0.4, 0.6 or 0.7mg/kg/day, with a maximum of 0.2mg/kg/day escalation every week.~Visits: There will be four visits; (visit 1) screening; (visit 2) treatment initiation, +2 weeks; (visit 3, telematic) +8 weeks; (visit 4) +14 weeks."
RECRUITING
Hospital Ruber Internacional, Madrid
Lead Sponsor
Zogenix, Inc.
INDUSTRY
Hospital Ruber Internacional
OTHER