FDA approves PHASE III clinical trial of AMZ002 for the treatment of epilepsy in infants

Infant epilepsy can lead to delayed overall neurodevelopment, severe intellectual disability, limited treatment options and poor prognosis.
most cases, the onset of the disease is between 3 and 12 months old, and more than 90% of cases begin before 12 months of age.
Prenatal factors leading to epilepsy in infants include abnormal fetal brain development, fetal cerebrovascular closure, prenatal fetal infection, congenital metabolic defects caused by the mother taking hormones, narcotics, alcohol, etc. during pregnancy, and genetic convulsions during pregnancy.
epilepsy is an orphan disease that affects fewer than 200,000 patients in the United States.
lack of treatment options for the disease means that there are considerable unsealed medical needs.
pharmaceutical company AMZELL recently announced that it has concluded discussions with the FDA and will conduct a Phase III clinical trial of AMZ002 to treat epilepsy in infants.
Dr. Dario N. Carrara, Chief Scientific Officer of AMZELL, said, "We are pleased to receive positive feedback from the FDA on our proposed Phase III trial of AMZ002 and hope to launch it in the coming months."
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