The efficacy, safety, and tolerability of CBD-OS have been evaluated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), and Tuberous sclerosis complex (TSC). The current JZP926-303 study is being conducted to evaluate the safety and efficacy of CBD-OS in participants with Developmental and Epileptic Encephalopathy (DEE).
Participants are eligible to be included in the study only if all the following criteria apply:
Participants are excluded from the study if any of the following criteria apply:
ClinicalTrialDisclosure@JazzPharma.com
Participants with DEE will be randomized to CBD-OS up to 10 mg/kg twice daily for a 6-week treatment period.
Participants with DEE will be randomized to matching placebo for a 6-week treatment period.
Participants with DEE who completed the double-blind phase of the study and enter the optional OLE will begin a 22-week open-label treatment period with CBD-OS up to 10 mg/kg twice daily following a 2-week Blinded Transition Period.
A Study to Investigate LP352 in Children and Adults With Developmental and Epileptic Encephalopathies (DEE)
A Study to Evaluate the Efficacy and Safety of Cannabidiol Oral Solution (CBD-OS [GWP42003-P, JZP926]) for the Treatment of Focal-Onset Seizures
A Study to Investigate LP352 in Children and Adults With Developmental and Epileptic Encephalopathy (DEE)
A Study to Investigate the Effect of Gradual Titration to Optimize Cannabidiol Treatment in Adults With LGS
Efficacy and Safety of GWP42003-P Oral Solution in Children With Epilepsy With Myoclonic-atonic Seizures
A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P; CBD) as Adjunctive Treatment for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults
A Clinical Trial of PRAX-562 in Subjects With Developmental and Epileptic Encephalopathies (DEE)
Efficacy and Safety of GWP42003-P for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults