Epidiolex® for Anxiety in Pediatric Epilepsy

Prior treatment

• Previous allergic or hypersensitivity reactions to Epidiolex® or cannabidiol
• Participation in a previous experimental drug study within 30 days of baseline visit.

Other illness

• Presence of psychotic illness or imminent risk of harm to self or others.
• Serious unstable medical or neurologic conditions such as HIV, liver or kidney disease, cancer or diabetes.
• Presence of Epilepsy Syndrome such as Sturge-Weber Syndrome that will be more suitable as a candidate in alternate research studies.

Lab values

• Baseline lab tests for liver specific transaminase, ALT, over the upper limit of normal (ULN).

Other

• No access to a phone or internet to complete remote visits (in-person visits acceptable for participants without devices)
• Active substance abuse or dependence
• Current standing use of benzodiazepines (except as "rescue" medicine)
• Cognitive functional capacity or English literacy that is insufficient to assure validity of clinical rating scales
• Insufficient capacity of caregiver or legal guardian to understand and appropriately consent for study procedures
• No exclusions for existing AEDs will be absolute, though consideration of additional monitoring will be in place for patients taking clobazam or valproate.
• Pregnant, planning to become pregnant, breast feeding, or failing to use an appropriate method of contraception.

• Established diagnosis of epilepsy, characterized by focal or generalized seizures. All participants will have active epilepsy that requires treatment with anticonvulsant medication.
• No episodes of seizure clusters of status epilepticus within 30 days prior to entry into the study.
• Established symptoms of anxiety with functional impairment.
• 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:
• 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.
• Ability to administer medicine orally
• 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.
• Participant or legal caregiver capable of providing informed consent and fully capable of monitoring the subject's disease process and compliance with treatment.
• 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.
• 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.