Epidiolex and Drug Resistant Epilepsy in Children

• Status: Available
• Trial end date: 2020-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This open-label, multi-center study is open to patients 1 to 18 years of age at time of enrollment with medication resistant epilepsy.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Augusta University
• Collaborator: State of Georgia
• Treatments: Cannabidiol

Criteria

Inclusion Criteria:

• Patient should have history of trying at least four antiepileptic drugs (AEDs), including one trial of a combination of two concomitant drugs, without successful seizure control. Vagal nerve stimulation, RNS deep brain stimulation, or the ketogenic diet can be considered equivalent to a drug trial.

• Patient must be taking two or more AEDs at a dose which has been stable for at least four weeks.

• A State of Georgia resident.

Exclusion Criteria:

• Patient is diagnosed as having Dravet Syndrome or Lennox-Gastaut Syndrome and eligible for a GW Pharmaceutical-Sponsored Clinical Trial.

• Patients who have been part of a clinical trial involving another investigational product in the previous six months.