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Epidiolex for Anxiety in Pediatric Epilepsy
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: treatment arm
- 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.
- 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.
Frequently Asked Questions
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."
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."
Are geriatric patients eligible for this experimental research?
"Based on the outlined requirements, participants must fall between 6 and 17 years old."
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."
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"
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