AnxietyPhase 4NCT05324449
Epidiolex® for Anxiety in Pediatric Epilepsy
A Phase 4 study testing Cannabidiol 100 MG/ML in people with Anxiety and Epilepsy, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 6 to 17 years
- What is being tested?
- Cannabidiol 100 MG/ML
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2022to 5 May 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
- 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:
- 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.
- Ability to administer medicine orally
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- 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.
Who cannot join
- 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)
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- 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
- No exclusions for existing AEDs will be absolute, though consideration of additional monitoring will be in place for patients taking clobazam or valproate.
- Pregnant, planning to become pregnant, breast feeding, or failing to use an appropriate method of contraception.
Trial locations and contacts
1 site in 1 country.
United States1 site
Kennedy Krieger Institute
Baltimore, Maryland, 21205
About this study
Official title: Epidiolex® For The Treatment Of Anxiety Comorbidity in Refractory Pediatric Epilepsy
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.
- Being tested
- Cannabidiol 100 MG/ML
- Medical subject headings
- Anxiety Disorders, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabidiol 100 MG/MLDrug
Also called Epidiolex
pharmaceutical grade cannabidiol
| Study group | Role | What they receive |
|---|---|---|
| treatment arm | Other | open label treatment intervention Receives: Drug: Cannabidiol 100 MG/ML |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start5 Apr 2022
- Primary completion17 Mar 2025
- Study completion5 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jay Salpekar, M.D., Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Investigators
- Jay Salpekar, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05324449
- Sponsor's protocol ID
- IRB00282248
- Status last verified
- Jun 2025
- First submitted
- 5 Apr 2022
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: data will be assembled and de-identified and analyzed in aggregate
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidiolex® For The Treatment Of Anxiety Comorbidity in Refractory Pediatric Epilepsy
- ClinicalTrials.gov ID
- NCT05324449
- Acronym / sponsor ID
- IRB00282248
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.University, hospital or other
- Study start
- 5 Apr 2022 (actual)
- Primary completion
- 17 Mar 2025 (actual)
- Study completion
- 5 May 2025 (actual)
- First posted
- 12 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment arm | Other | Drug: Cannabidiol 100 MG/MLopen label treatment intervention |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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.
- 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:
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabidiol 100 MG/MLAlso: Epidiolexpharmaceutical grade cannabidiol | Drug | treatment arm |
Primary outcome
CGI-I
Time frame: 16 weeks
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Background: PubMed 32839652Abu-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.
- Individual participant dataSharing planned: No. data will be assembled and de-identified and analyzed in aggregate
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jay Salpekar principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cannabidiol 100 MG/ML in people with Anxiety and Epilepsy, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CGI-I (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05324449, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.