Phase
Condition
Epilepsy
Anxiety Disorders
Panic Disorders
Treatment
Cannabidiol 100 MG/ML
Clinical Study ID
Ages 6-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Established diagnosis of epilepsy, characterized by focal or generalized seizures.All participants will have active epilepsy that requires treatment withanticonvulsant medication.
No episodes of seizure clusters of status epilepticus within 30 days prior to entryinto the study.
Established symptoms of anxiety with functional impairment.
Baseline behavioral criteria for inclusion will include subscale scores for anxietyabove the norm for age and gender inth e 60 days prior to the study on one of thefollowing:
Male or female participants equal to or above age 6 and below age 18 at the start ofthe 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 withdrewearly 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 fullycapable of monitoring the subject's disease process and compliance with treatment.
Participants who are sexually active, must agree to sexual abstinence, or, to use anapproved birth control method for the full duration of study participation.
No active use of CBD products within the 14 days prior to screening visit andcommitment to only use study product for the duration of the study.
Exclusion
Exclusion Criteria:
Baseline lab tests for liver specific transaminase, ALT, over the upper limit ofnormal (ULN).
Previous allergic or hypersensitivity reactions to Epidiolex® or cannabidiol
No access to a phone or internet to complete remote visits (in-person visitsacceptable for participants without devices)
Active substance abuse or dependence
Presence of psychotic illness or imminent risk of harm to self or others.
Current standing use of benzodiazepines (except as "rescue" medicine)
Serious unstable medical or neurologic conditions such as HIV, liver or kidneydisease, cancer or diabetes.
Presence of Epilepsy Syndrome such as Sturge-Weber Syndrome that will be moresuitable as a candidate in alternate research studies.
Participation in a previous experimental drug study within 30 days of baselinevisit.
Cognitive functional capacity or English literacy that is insufficient to assurevalidity of clinical rating scales
Insufficient capacity of caregiver or legal guardian to understand and appropriatelyconsent for study procedures
No exclusions for existing AEDs will be absolute, though consideration of additionalmonitoring will be in place for patients taking clobazam or valproate.
Pregnant, planning to become pregnant, breast feeding, or failing to use anappropriate method of contraception.
Study Design
Study Description
Connect with a study center
Kennedy Krieger Institute
Baltimore, Maryland 21205
United StatesActive - Recruiting
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