Fenfluramine for the Treatment of Different Types of Developmental and Epileptic Encephalopathies: a Pilot Trial Exploring Epileptic and Non-epileptic Outcomes

PHASE4RecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

October 20, 2022

Primary Completion Date

February 20, 2025

Study Completion Date

June 20, 2025

Conditions
Refractory EpilepsySYNGAP1 EncephalopathySTXBP1 Encephalopathy With EpilepsyInv Dup(15) EncephalopathyMultifocal or Bilateral Malformations of Cortical DevelopmentContinuous Spike and Waves During Slow Sleep
Interventions
DRUG

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."

Trial Locations (1)

28034

RECRUITING

Hospital Ruber Internacional, Madrid

Sponsors
All Listed Sponsors
collaborator

Zogenix, Inc.

INDUSTRY

lead

Hospital Ruber Internacional

OTHER

NCT05232630 - Fenfluramine for the Treatment of Different Types of Developmental and Epileptic Encephalopathies: a Pilot Trial Exploring Epileptic and Non-epileptic Outcomes | Biotech Hunter | Biotech Hunter