Fenflurmaine in CKDL5 Deficiency Disorder (CDD)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Cdkl5
  • Age: Between 2 - 18 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Subjects have been informed and written informed consent or assent has been given before any study procedures have started.
    2. Subjects confirmed clinical/genetic diagnosis of CDKL5 Deficiency Disorder CDD
    3. Subject’s caregiver is willing and able to be compliant with diary completion, visit schedule and study drug accountability.
    4. Subjects must be receiving a therapeutically relevant and stable dose of anti-seizure medications, dietary therapies for epilepsy or vagus nerve stimulation settings for at least 4 weeks prior to screening and are expected to remain stable throughout the initial 14 weeks of the study. Medication changes are allowed during the extension portion.
    5. Subjects with =4 convulsive seizures (tonic-clonic, tonic, atonic, clonic, focal motor) per 4-week period; each convulsive seizure must last =3 seconds
    6. Subjects are receiving at least 1 concomitant AED and up to 4 concomitant AEDs, inclusive.

You may not be eligible for this study if the following are true:

    1. Subjects have a known hypersensitivity to fenfluramine or any of the excipients in the study medication
    2. Subjects have current or past history of cardiovascular or cerebrovascular disease, myocardial infarction or stroke
    3. Subjects have current or past history of cardiovascular or cerebrovascular disease, such as cardiac valvulopathy, myocardial infarction or stroke, or clinically significant structural cardiac abnormality, including but not limited to mitral valve prolapse, atrial or ventricular septal defects, patent ductus arteriosis, and patent foramen ovale with reversal of shunt
    4. Subjects have current or recent history of Anorexia Nervosa, bulimia, or depression within the prior year that required medical treatment or psychological treatment for a duration greater than 1 month.
    5. Subjects who are currently on formulations of CBD (other than Epidiolex) , CBD/THC or any MMJ
    6. Subjects who are at imminent risk of self-harm or harm to others, in the investigator’s opinion, based on clinical interview
    7. Subjects who have current or past history of glaucoma
    8. Subjects with moderate or severe hepatic impairment



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