U.S., June 10 -- ClinicalTrials.gov registry received information related to the study (NCT07635862) titled 'Clinical Trial Evaluating the Effects of Ganaxolone in Children With Autism' on June 03.
Brief Summary: The goal of this study is to conduct a randomized, placebo-controlled trial (RCT) of ganaxolone, a neuroactive steroid (NAS), in autistic children and adolescents aged 5 to 17 years old. Ganaxolone is approved and effective for treating seizures in children as young as 2 years old who have CDKL5 deficiency disorder (CDD), a neurogenetic condition associated with developmental delays, seizure disorder, hypotonia, visual impairments, and autistic features. The primary outcome of interest for this trial is irritability on the Aberran...