COMPLETED

Epidiolex® for Anxiety in Pediatric Epilepsy

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-04-05

Study Completion:2025-05-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05324449

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Principal Investigator

Jay Salpekar

PRINCIPAL_INVESTIGATOR

Principal Investigator

Study Locations (Sites)

Kennedy Krieger Institute

Baltimore, Maryland, 21205

United States

Collaborators and Investigators

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

Jay Salpekar, PRINCIPAL_INVESTIGATOR, Principal Investigator

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-05

Study Completion Date2025-05-05

Study Record Updates

Study Start Date2022-04-05

Study Completion Date2025-05-05

Terms related to this study

Additional Relevant MeSH Terms

Anxiety
Epilepsy