Epidiolex® for Anxiety in Pediatric Epilepsy

Last updated: May 22, 2024
Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Overall Status: Active - Recruiting

Phase

4

Condition

Epilepsy

Anxiety Disorders

Panic Disorders

Treatment

Cannabidiol 100 MG/ML

Clinical Study ID

NCT05324449
IRB00282248
  • Ages 6-17
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Established diagnosis of epilepsy, characterized by focal or generalized seizures.All participants will have active epilepsy that requires treatment withanticonvulsant medication.

  2. No episodes of seizure clusters of status epilepticus within 30 days prior to entryinto the study.

  3. Established symptoms of anxiety with functional impairment.

  4. 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:

  5. 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.

  6. Ability to administer medicine orally

  7. 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.

  8. Participant or legal caregiver capable of providing informed consent and fullycapable 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 anapproved 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 andcommitment to only use study product for the duration of the study.

Exclusion

Exclusion Criteria:

  1. Baseline lab tests for liver specific transaminase, ALT, over the upper limit ofnormal (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 visitsacceptable 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 kidneydisease, cancer or diabetes.

  8. Presence of Epilepsy Syndrome such as Sturge-Weber Syndrome that will be moresuitable as a candidate in alternate research studies.

  9. Participation in a previous experimental drug study within 30 days of baselinevisit.

  10. Cognitive functional capacity or English literacy that is insufficient to assurevalidity of clinical rating scales

  11. Insufficient capacity of caregiver or legal guardian to understand and appropriatelyconsent for study procedures

  12. No exclusions for existing AEDs will be absolute, though consideration of additionalmonitoring will be in place for patients taking clobazam or valproate.

  13. Pregnant, planning to become pregnant, breast feeding, or failing to use anappropriate method of contraception.

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Cannabidiol 100 MG/ML
Phase: 4
Study Start date:
April 05, 2022
Estimated Completion Date:
April 04, 2026

Study Description

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.

Connect with a study center

  • Kennedy Krieger Institute

    Baltimore, Maryland 21205
    United States

    Active - Recruiting

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