Cannabidiol Oral Solution for Treatment of Refractory Infantile Spasms
Status:
Terminated
Trial end date:
2016-09-06
Target enrollment:
Participant gender:
Summary
Infantile Spasms (IS) is a diagnosis described as a fairly rare and terrible form of epilepsy
that usually strikes children in the first year of life. There is a great need for safe and
effective therapies in the treatment of IS. This need is even more important for infants and
toddlers still sick after being treated with medicine that is already available.
This is a multi-center study to evaluate the efficacy and safety of Cannabidiol Oral Solution
(CBD) in the treatment of children aged 6 months through 36 months with a diagnosis of
infantile spasms who have not responded to first line therapies.
The overall study duration is expected to be 64 weeks for those subjects who respond to CBD
treatment. The maximum possible study duration for each patient is approximately 64 weeks,
however a subject will be deemed to have completed the study after 58 weeks.