Fenfluramine in CDKL5 Deficiency Disorder (CDD)

Phase 2 Completed 7 enrolled NYU Langone Health

NaSingle-groupOpen-labelTreatment

Summary

This study will be enrolling 10 patients, ages 2-18 years old, with a confirmed genetic/clinical diagnosis of CDKL5 Deficiency Disorder (CDD) in an open label trial of fenfluramine for seizure control. Patients will be titrated over 14 days to a dose of ZX008 0.8 mg/kg/day (maximum dose 30 mg/d).

Timeline

Start: 2019-10-29
Primary completion: 2022-08-30
Completion: 2022-10-24

Publications

Devinsky O, King L, Schwartz D, Conway E, Price D. Effect of fenfluramine on convulsive seizures in CDKL5 deficiency disorder. Epilepsia. 2021 Jul;62(7):e98-e102. doi: 10.1111/epi.16923. Epub 2021 May 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fenfluramine	Small molecule	0.8 mg/kg	Oral

Indications

No indication recorded.