CDKL5 Fenfluramine Study

NOW OPEN!

Dr. Orrin Devinsky has received FDA and IRB approval for a phase 2 study of fenfluramine in children with CDKL5 Deficiency Disorder (CDD). This study is only available at NYU Langone Health. It will enroll 10 patients, ages 2-18 years old, with a confirmed genetic/clinical diagnosis of CDD in this open label trial of fenfluramine for seizure control. There is no charge for visits or laboratory studies related to the study but no funds for travel are available.

Inclusion criteria:

  1. 2-18 years w/ confirmed with diagnosis of CDD
  2. On 1-4 AEDs (VNS, diets and rescue do not count)
  3. Stable AEDs for 4 weeks
  4. At least 4 convulsive seizures per 4-week period; each must last at least 3 seconds

Exclusion criteria:

  1. Current or past history of cardiovascular or cerebrovascular disease, myocardial infarction or stroke
  2. Current or recent history of Anorexia Nervosa, bulimia, or depression within the prior year
  3. Currently on CBD/THC or any MMJ that is not Epidiolex
  4. Risk for self-harm
  5. Current or past history of glaucoma
  6. Receiving concomitant therapy with: centrally-acting anorectic agents; monoamine-oxidase inhibitors; any centrally-acting compound with clinically appreciable amount of serotonin agonist or antagonist properties, including serotonin reuptake inhibition; atomoxetine, or other centrally-acting noradrenergic agonist; or cyproheptadine.
  7. Moderate or severe hepatic impairment
Contact: Latoya King
Phone: (646) 558-0838
Learn more at clinicaltrials.gov