Cannabidiol for Pediatric Epilepsy (Compassionate Use)
Status:
No longer available
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
This is an open-label observational study of pure CBD for the treatment for 25 children with
intractable epilepsy. As pure CBD is not FDA approved, the investigators are conducting this
study via the FDA expanded access mechanism on a compassionate use basis. The target patient
population is children with severe refractory epilepsy who have exhausted all other
reasonable avenues of treatment. These are patients for whom the risks of a relatively
untested product are outweighed by the potential benefit. Using seizure-diaries maintained on
a routine clinical basis, seizure frequency will be assessed four weeks prior to initiation
of CBD, one month after CBD initiation, and at least every 3 months thereafter. CBD will be
administered as an adjunct to all current anti-epileptic therapies.