Epidiolex® for Anxiety in Pediatric Epilepsy

Eligibility Criteria

• 1. Established diagnosis of epilepsy, characterized by focal or generalized seizures. All participants will have active epilepsy that requires treatment with anticonvulsant medication.
• 2. No episodes of seizure clusters of status epilepticus within 30 days prior to entry into the study.
• 3. Established symptoms of anxiety with functional impairment.
• 4. Baseline behavioral criteria for inclusion will include subscale scores for anxiety above the norm for age and gender inth e 60 days prior to the study on one of the following:
• 5. Male or female participants equal to or above age 6 and below age 18 at the start of the study. No exclusion will be made on the basis of gender or minority status.
• 6. Ability to administer medicine orally
• 7. Previous subjects who failed at any point to meet continuation criteria and withdrew early may be considered for re-enrollment by the PI on a case-by-case basis.
• 8. Participant or legal caregiver capable of providing informed consent and fully capable of monitoring the subject's disease process and compliance with treatment.
• 9. Participants who are sexually active, must agree to sexual abstinence, or, to use an approved birth control method for the full duration of study participation.
• 10. No active use of CBD products within the 14 days prior to screening visit and commitment to only use study product for the duration of the study.
• 1. Baseline lab tests for liver specific transaminase, ALT, over the upper limit of normal (ULN).
• 2. Previous allergic or hypersensitivity reactions to Epidiolex® or cannabidiol
• 3. No access to a phone or internet to complete remote visits (in-person visits acceptable for participants without devices)
• 4. Active substance abuse or dependence
• 5. Presence of psychotic illness or imminent risk of harm to self or others.
• 6. Current standing use of benzodiazepines (except as "rescue" medicine)
• 7. Serious unstable medical or neurologic conditions such as HIV, liver or kidney disease, cancer or diabetes.
• 8. Presence of Epilepsy Syndrome such as Sturge-Weber Syndrome that will be more suitable as a candidate in alternate research studies.
• 9. Participation in a previous experimental drug study within 30 days of baseline visit.
• 10. Cognitive functional capacity or English literacy that is insufficient to assure validity of clinical rating scales
• 11. Insufficient capacity of caregiver or legal guardian to understand and appropriately consent for study procedures
• 12. No exclusions for existing AEDs will be absolute, though consideration of additional monitoring will be in place for patients taking clobazam or valproate.
• 13. Pregnant, planning to become pregnant, breast feeding, or failing to use an appropriate method of contraception.