INSYS Therapeutics, Inc. announced initiation of a Phase III clinical trial to study cannabidiol oral solution for the treatment of infantile spasms.
INSYS Therapeutics, Inc. announced the initiation of a Phase III clinical trial to study cannabidiol (CBD) oral solution for the treatment of infantile spasms, a rare type of pediatric epilepsy that occurs in very young children, with the first trial site�s activation.
In previous studies, CBD�one of the main molecules in cannabis�has demonstrated sustained clinical benefits in a variety of medically refractory pediatric epilepsies, including infantile spasms, an uncommon condition estimated by the Child Neurology Foundation (CNF) to be diagnosed in about 1,200 children in the United States each year. According to the Infantile Spasms Action Network (ISAN), a collaborative advocacy network of 25 national and international organizations convened by CNF, infantile spasms have an average age of onset of around four months, although in some cases the first seizure occurs as early as one month or as late as two years. In most cases, infantile spasms appear to be slight head drops, which belie the seriousness of the condition. Evidence shows that infantile spasms are a more serious seizure disorder than generalized convulsions.