Your session is about to expire
← Back to Search
Cannabinoid
Epidiolex for Anxiety in Pediatric Epilepsy
Phase 4
Recruiting
Led By Jay Salpekar
Research Sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Established symptoms of anxiety with functional impairment
Established diagnosis of epilepsy, characterized by focal or generalized seizures requiring treatment with anticonvulsant medication
Must not have
Insufficient capacity of caregiver or legal guardian to understand and appropriately consent for study procedures
Current standing use of benzodiazepines (except as 'rescue' medicine)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights
Summary
This trial will test if a pharmaceutical-grade cannabidiol called Epidiolex can help treat anxiety in children with epilepsy that hasn't responded well to other medications.
Who is the study for?
This trial is for children and teens aged 6-18 with epilepsy and anxiety who are on anticonvulsant medication, haven't had severe seizures recently, can take oral medicine, and aren't using other CBD products. Participants need reliable caregivers for consent and must use birth control if sexually active.
What is being tested?
The study tests Epidiolex (cannabidiol) to see if it helps with anxiety in young patients with hard-to-treat epilepsy. It's an open label study where everyone knows they're getting the actual drug, not a placebo.
What are the potential side effects?
Epidiolex may cause side effects like sleepiness, decreased appetite, diarrhea, fever, vomiting, fatigue. More serious but less common side effects include liver issues or allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I experience anxiety that affects my daily activities.
Select...
I have epilepsy and need medication to control my seizures.
Select...
I can take medicine by mouth.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My caregiver or legal guardian cannot fully understand or consent to the study procedures for me.
Select...
I regularly use benzodiazepines, not just for emergencies.
Select...
I am allergic to Epidiolex® or cannabidiol.
Select...
I do not have serious conditions like HIV, liver or kidney disease, cancer, or diabetes.
Select...
I may have trouble understanding or speaking English well enough for medical assessments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
CGI-I
Trial Design
1Treatment groups
Experimental Treatment
Group I: treatment armExperimental Treatment1 Intervention
open label treatment intervention
Find a Location
Who is running the clinical trial?
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.Lead Sponsor
88 Previous Clinical Trials
24,927 Total Patients Enrolled
1 Trials studying Epilepsy
20 Patients Enrolled for Epilepsy
Jay SalpekarPrincipal InvestigatorPrincipal Investigator
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I experience anxiety that affects my daily activities.My caregiver or legal guardian cannot fully understand or consent to the study procedures for me.I have epilepsy and need medication to control my seizures.I haven't had any seizures or seizure clusters in the last 30 days.I am taking epilepsy drugs, but I'm open to extra monitoring if needed.I can take medicine by mouth.I haven't used CBD products in the last 14 days and will only use the study product.I regularly use benzodiazepines, not just for emergencies.I or my caregiver can make informed decisions and follow the treatment plan.I am allergic to Epidiolex® or cannabidiol.I do not have serious conditions like HIV, liver or kidney disease, cancer, or diabetes.I may have trouble understanding or speaking English well enough for medical assessments.I am between 6 and 18 years old.I have been more anxious than usual for my age and gender in the last 60 days.
Research Study Groups:
This trial has the following groups:- Group 1: treatment arm
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger