Epidiolex® for Anxiety in Pediatric Epilepsy (NCT05324449) | Clinical Trial Compass
CompletedPhase 4
Epidiolex® for Anxiety in Pediatric Epilepsy
United States20 participantsStarted 2022-04-05
Plain-language summary
This is a prospective open label study assessing the efficacy and tolerability of pharmaceutical grade cannabidiol--Epidiolex (R), for the treatment of anxiety in pediatric patients with pediatric epilepsy that has been difficult to treat and requires ongoing use of anticonvulsant medication.
Who can participate
Age range6 Years – 17 Years
SexALL
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Inclusion criteria
✓. 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:
Exclusion criteria
✕. 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.
✕0. 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.
✕. Baseline lab tests for liver specific transaminase, ALT, over the upper limit of normal (ULN).
What they're measuring
1
CGI-I
Timeframe: 16 weeks
Trial details
NCT IDNCT05324449
SponsorHugo W. Moser Research Institute at Kennedy Krieger, Inc.