A Phase 4 interventional study of Cannabidiol 100 MG/ML in Anxiety and Epilepsy, sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.. Completed at 1 site in United States. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2025-07-02.
Sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. · Phase 4, Interventional, and Treatment
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.
This study is an open label, adjunctive, proof of concept clinical trial. Prospective participants will be considered for the study if neurologic status suggests the need for continued treatment, and behavioral characteristics are clinically significant. All participants will receive active treatment, involving flexible dose titration of Epidiolex® and will be monitored for a period of four months. The study will be monitored and overseen by the Johns Hopkins Hospital Institutional Review Board.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's enrollment of 20 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Hugo W. Moser Research Institute at Kennedy Krieger, Inc. is the lead sponsor of 76 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
open label treatment intervention
Drug: Cannabidiol 100 MG/ML
pharmaceutical grade cannabidiol
Also known as: Epidiolex
CGI-I
Mean of Clinical Global Impression-Improvement (CGI-I) from baseline. The CGI is rated on a 7-point scale. (lower score represents a better outcome: 1/ High score represents minimum improvement: 7)
Time frame: 16 weeks
Plan to share: No — data will be assembled and de-identified and analyzed in aggregate
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Hugo W. Moser Research Institute at Kennedy Krieger, Inc.