CClinicalTrials.gg
CompletedNCT05324449Updated Jul 2, 2025

Epidiolex® for Anxiety in Pediatric Epilepsy

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

From the registry’s dates

  • Primary completion was Mar 2025, 1 year 6 months ago, and no results have been posted to the registry.
Phase
Phase 4
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
6 Years to 17 Years
Sex
All
01

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.

Read the detailed 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.

02

Conditions studied

  • Anxiety
  • Epilepsy
03

In context

Anxiety Disorders

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
6 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Other
    treatment arm

    open label treatment intervention

    Drug: Cannabidiol 100 MG/ML

Interventions

  • DrugCannabidiol 100 MG/ML

    pharmaceutical grade cannabidiol

    Also known as: Epidiolex

06

What researchers measure

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)

    Time frame: 16 weeks

07

Study locations

1 site
  • Kennedy Krieger Institute
    Baltimore, Maryland 21205, United States
08

References and documents

Publications

  • 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. PubMed 32839652 ↗

Individual participant data

Plan to share: No — data will be assembled and de-identified and analyzed in aggregate

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05324449
Lead sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Responsible party
Jay Salpekar, M.D. (Principal Investigator, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.) — Principal investigator
First posted
Apr 12, 2022
Start date
Apr 5, 2022
Primary completion
Mar 17, 2025
Completion
May 5, 2025
Last update
Jul 2, 2025

Study contacts

Jay Salpekar
principal investigator · Principal Investigator

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion