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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
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

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 below
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I experience anxiety that affects my daily activities.
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I have epilepsy and need medication to control my seizures.
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I can take medicine by mouth.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My caregiver or legal guardian cannot fully understand or consent to the study procedures for me.
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I regularly use benzodiazepines, not just for emergencies.
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I am allergic to Epidiolex® or cannabidiol.
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I do not have serious conditions like HIV, liver or kidney disease, cancer, or diabetes.
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I may have trouble understanding or speaking English well enough for medical assessments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
CGI-I

Awards & Highlights

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.

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
89 Previous Clinical Trials
24,843 Total Patients Enrolled
1 Trials studying Epilepsy
20 Patients Enrolled for Epilepsy
Jay SalpekarPrincipal InvestigatorPrincipal Investigator

Media Library

Epidiolex (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT05324449 — Phase 4
Epilepsy Research Study Groups: treatment arm
Epilepsy Clinical Trial 2023: Epidiolex Highlights & Side Effects. Trial Name: NCT05324449 — Phase 4
Epidiolex (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05324449 — Phase 4
~2 spots leftby Apr 2025
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