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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
24,918 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being admitted to this research project?

"Affirmative. According to the records on clinicaltrials.gov, this research is currently onboarding participants. The investigation was initially released on April 5th 2022 and most recently updated a few weeks later, in late April of 2022. This particular trial requires 20 subjects from one location for completion."

Answered by AI

Are any volunteers being sought for this research endeavor?

"The most recent post on clinicaltrials.gov confirms that the trial is still recruiting participants, having been originally posted in April 5th 2022 and last updated on April 29th of the same year."

Answered by AI

Are geriatric patients eligible for this experimental research?

"Based on the outlined requirements, participants must fall between 6 and 17 years old."

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Has this particular treatment received the necessary authorization from the Food and Drug Administration?

"The safety of this treatment is rated 3 on our scale, as the Phase 4 clinical trial indicates that it has been approved."

Answered by AI

May I partake in this clinical trial?

"This medical trial is enrolling 20 minors aged 6-17 with aura. The eligibility criteria include: a diagnosed form of epilepsy characterized by focal or generalized seizures; absence of seizure clusters for the last 30 days; symptoms and functional impairment caused by anxiety, ability to take medicine orally; prior subjects who dropped out early may be reenrolled on a case-by-case basis; capable caregiver that can provide informed consent and monitor the patient's illness and compliance with treatment ; sexually active participants must practice sexual abstinence or use approved contraceptive methods throughout the study duration; no CBD products in two weeks preceding screening visit with commitment to only use study product"

Answered by AI
~7 spots leftby Apr 2025