Epidiolex and Drug Resistant Epilepsy in Children
ConditionEpilepsy
Trial statusAvailable
Trial phaseNot listed
Trial typeExpanded Access
Biological sexAll
Age1-18
SponsorAugusta University
About this trial
This open-label, multi-center study is open to patients 1 to 18 years of age at time of enrollment with medication resistant epilepsy.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Cannabidiol (Epidiolex)
Treatment groups
No treatment groups listed
Sponsors and collaborators
Augusta University
Lead sponsor
State of Georgia
Collaborator
Source ClinicalTrials.gov