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Cannabidiol Expanded Access Study in Medically Refractory Sturge-Weber Syndrome

Sturge-Weber Syndrome Clinical Trial

Official title:
Cannabidiol Expanded Access Study in Medically Refractory Sturge-Weber Syndrome

Clinical Trial Summary

The purpose of this study is to determine the tolerability and optimal dose of cannabidiol (CBD) as an simultaneous treatment in children and young adults with Sturge-Weber syndrome (SWS) and drug resistant epilepsy.

Clinical Trial Description

We hope to gain an understanding of the utility of pure CBD used for the treatment of medically refractory epilepsy in SWS in this open-label, safety dose-finding, study. Recent evidence suggests that CBD has multiple, beneficial, effects in patients (such as those with SWS that undergo neurological deterioration) suffering from medically refractory seizures. We hypothesize that CBD will reduce seizure frequency in children and young adults with SWS and will therefore help stabilize and improve their neurologic status.This trial is part of an expanded access program, available through a partnership with GW Pharmaceutical, which has been sanctioned by the FDA to study the safety and efficacy of Epidiolex (cannabidiol/CBD) in participants with SWS and medically refractory seizures. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02332655
Study type Interventional
Source Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Contact
Status Completed
Phase Phase 1/Phase 2
Start date December 2014
Completion date April 2021
View Details
See also
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