Epidiolex® for Anxiety in Pediatric Epilepsy

NCT05324449 | Completed Phase 4 FDA Drug

• 1 other identifier: IRB00282248
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxiety; Epilepsy

Outcome Measures

Primary Outcomes (1)

• 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)

  16 weeks

Study Arms (1)

treatment arm

OTHER

open label treatment intervention

Drug: Cannabidiol 100 MG/ML

Interventions

Cannabidiol 100 MG/ML DRUG

pharmaceutical grade cannabidiol

Also known as: Epidiolex

treatment arm

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• Baseline lab tests for liver specific transaminase, ALT, over the upper limit of normal (ULN).
• Previous allergic or hypersensitivity reactions to Epidiolex® or cannabidiol
• No access to a phone or internet to complete remote visits (in-person visits acceptable 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 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.
• Participation in a previous experimental drug study within 30 days of baseline visit.
• 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
• Pregnant, planning to become pregnant, breast feeding, or failing to use an appropriate method of contraception.

Sponsors & Collaborators

• Hugo W. Moser Research Institute at Kennedy Krieger, Inc.: lead

Study Sites (1)

Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

Location

Related Publications (1)

• Abu-Sawwa R, Scutt B, Park Y. Emerging Use of Epidiolex (Cannabidiol) in Epilepsy. J Pediatr Pharmacol Ther. 2020;25(6):485-499. doi: 10.5863/1551-6776-25.6.485.

  PMID: 32839652 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Epilepsy

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Jay Salpekar

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: April 12, 2022
• Study Start: April 5, 2022
• Primary Completion: March 17, 2025
• Study Completion: May 5, 2025
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)