View clinical trials related to Epilepsy.
Filter by:The purpose of this study is to determine if cannabidiol is safe and effective at different doses as an additional treatment for pediatric drug-resistant epilepsy. Pure cannabidiol has potentially therapeutic properties, such as anti-convulsant effects, that may reduce seizure frequency. There are only a few open label studies that have demonstrated the safety and tolerance of cannabiodiol in both adult and pediatric epileptic populations--these studies were performed either retrospectively or with varying cannabidiol preparations. There are no well-documented studies and completely analyzed data for pediatric epileptic patients.
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.
The main goal of this study is to provide treatment with cannabidiol (CBD) to children with drug resistant epilepsy through a Physician Expanded Access Investigation New Drug protocol. As the controlled therapeutic use of CBD in children is novel, the primary objective of this study is to evaluate the safety and efficacy of CBD when administered as adjunctive therapy in children that have exhausted the majority of FDA approved antiepileptic drug treatment options.
This is an expanded access use of Stiripentol in Dravet Syndrome or epileptic encephalopathies associated with sodium channel mutations who have failed other drugs in an effort to give them the best chance at seizure control and quality of life. As a treatment protocol and not a research study, children will only be monitored on a clinical basis for seizure improvement and side effects predominantly by parent and caregiver report.