Using Epidiolex to treat anxiety in children with epilepsy

Epidiolex® For The Treatment Of Anxiety Comorbidity in Refractory Pediatric Epilepsy

This study is testing if Epidiolex can help reduce anxiety in children aged 6 to 17 who have epilepsy.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 6 Years to 17 Years
• Sex: All
• Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc. (Academic / other)
• Locations: 1 site (Baltimore, Maryland)
• Trial ID: NCT05324449 on ClinicalTrials.gov

What this trial studies

This open label clinical trial evaluates the effectiveness and tolerability of Epidiolex, a pharmaceutical grade cannabidiol, for managing anxiety in pediatric patients suffering from epilepsy. Participants will be children aged 6 to 17 who have active epilepsy and significant anxiety symptoms. The study involves flexible dose titration of Epidiolex over a four-month period, with all participants receiving the active treatment. The trial is overseen by the Institutional Review Board at Johns Hopkins Hospital to ensure safety and compliance.

Who should consider this trial

Good fit: Ideal candidates are children aged 6 to 17 with a diagnosis of epilepsy and clinically significant anxiety symptoms.

Not a fit: Patients without active epilepsy or those who do not exhibit significant anxiety symptoms may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce anxiety symptoms in children with epilepsy, improving their overall quality of life.

How similar studies have performed: Other studies have shown promise in using cannabidiol for various conditions, suggesting potential success for this approach in treating anxiety in pediatric epilepsy.

Eligibility criteria

Inclusion Criteria:

1. Established diagnosis of epilepsy, characterized by focal or generalized seizures. All participants will have active epilepsy that requires treatment with anticonvulsant medication.
2. No episodes of seizure clusters of status epilepticus within 30 days prior to entry into the study.
3. Established symptoms of anxiety with functional impairment.
4. 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:
5. 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.
6. Ability to administer medicine orally
7. 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.
8. Participant or legal caregiver capable of providing informed consent and fully capable of monitoring the subject's disease process and compliance with treatment.
9. 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.
10. 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.

Exclusion Criteria:

1. Baseline lab tests for liver specific transaminase, ALT, over the upper limit of normal (ULN).
2. Previous allergic or hypersensitivity reactions to Epidiolex® or cannabidiol
3. No access to a phone or internet to complete remote visits (in-person visits acceptable for participants without devices)
4. Active substance abuse or dependence
5. Presence of psychotic illness or imminent risk of harm to self or others.
6. Current standing use of benzodiazepines (except as "rescue" medicine)
7. Serious unstable medical or neurologic conditions such as HIV, liver or kidney disease, cancer or diabetes.
8. Presence of Epilepsy Syndrome such as Sturge-Weber Syndrome that will be more suitable as a candidate in alternate research studies.
9. Participation in a previous experimental drug study within 30 days of baseline visit.
10. Cognitive functional capacity or English literacy that is insufficient to assure validity of clinical rating scales
11. Insufficient capacity of caregiver or legal guardian to understand and appropriately consent for study procedures
12. No exclusions for existing AEDs will be absolute, though consideration of additional monitoring will be in place for patients taking clobazam or valproate.
13. Pregnant, planning to become pregnant, breast feeding, or failing to use an appropriate method of contraception.

Where this trial is running

Baltimore, Maryland

• Kennedy Krieger Institute — Baltimore, Maryland, United States (Recruiting)

Study contacts

• Principal investigator: Jay Salpekar — Principal Investigator
• Study coordinator: Catherine Eliades

Conditions Anxiety; Epilepsy