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
This trial does not accept healthy volunteersQualifiers
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)
DrugDaily dosage up to 25 mg/kg/day with an optional up titration to a maximal daily dosage up to 50 m/kg/day until End of Treatment.
Treatment groups
No treatment groups listed
Trial outcomes
This trial has no outcomes listed.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Augusta University
Lead sponsor
State of Georgia
Collaborator
Source ClinicalTrials.gov