UAB Cannabidiol Program

Overview

The UAB Epilepsy Center at the University of Alabama at Birmingham will be conducting a study of cannabidiol, or CBD, in children and adults with severe seizure disorders that are not controlled by existing treatments. CBD is a plant-based supplement derived from the cannabis plant. It is a light, oily liquid that will be delivered orally. All those enrolled in the study will receive CBD.

Access to the program

If you are interested in being considered for the UAB CBD Adult or Pediatric Programs, you will need to submit a cover letter checklist, referral letter from your primary treating neurologist, and the medical record information included in these instructions. The letter should state your primary treating neurologist’s referral for you to be treated in the CBD study. Templates of the cover letter checklist and primary treating neurologist referral letter are available through the links at the bottom of this page. A printable copy of these instructions is also included in the links at the bottom.

You will need to have your medical history/records mailed with the cover letter checklist, and referral letter from your primary treating neurologist. The medical records should include, at the very least, the following information:

Report of most recent Brain MRI (Include date of MRI report)

Report of most recent Electrocardiogram (ECG) (Include date of ECG report)

Report of video/EEG monitoring confirming the diagnosis of epilepsy,

Digital copy of a routine EEG along with the formal written report performed within 3 months prior to submitting these records for CBD Treatment Approval Committee review,

Documentation of failed AEDs, including one trial of a combination of two concomitant AEDs, without successful seizure control.

Documentation of between 1-4 baseline anti-epileptic drugs at stable doses for a minimum of 4 weeks prior to submitting these records for CBD Treatment Approval Committee review.

Current Medication List

If applicable, documentation of VNS or RNS implantation and evidence that settings have not been adjusted within 3 months prior to submitting these records for CBD Treatment Approval Committee review,

If applicable, provide report of Corpus Callostomy or other prior epilepsy surgery (Include the date of the surgery).

If on ketogenic diet, documentation that you have been on stable ratio for a minimum of 3 months.

Documentation indicating seizure type(s), and number of seizures of each type per month

Documentation of seizure calendar for at least 3 months prior to submitting these records for CBD Treatment Approval Committee review; the patient will need to provide an updated calendar at the time of enrollment.

Results of routine laboratory studies, including but not limited to CBC, CMP, LFTs, renal panel, UA, and levels of all AEDs within 3 months prior to submitting these records for CBD Treatment Approval Committee review. If any AED dose was adjusted within 3 months prior to submitting these records for review by the CBD Treatment Approval Committee, level on the new dose will need to be provided.

Results of any metabolic or genetic testing that have been completed, including any laboratory diagnostic genetic testing that have confirmed the diagnosis for the epilepsy (Dravet Syndrome, etc.)

If your referring neurologist has any questions, please have them call the Program Manager at 205-975-8883.

**Please note, you have to contact your current treating neurologist to obtain this documentation and you or your referring neurologist are responsible for getting this information to the CBD Program Manager for review.**

Instructions for Submitting Documentation/Proof of Alabama Residency

In addition to the above medical history/records documentation, you will need to submit documentation of Alabama residency. Acceptable documentation of Alabama residency includes the following:

a state issued ID, such as a driver's license, from patient or patient’s parent/ legally authorized representative (LAR),

documents showing the patient or patient’s parent/LAR rents/owns property in the state,

state voter registration from patient or patient’s parent/LAR, or

a recent state tax return from patient or patient’s parent/LAR.

When you have all information ready, including the Alabama residency verification, cover letter checklist, primary care neurologist’s referral letter, and your medical records/history information, send to the address listed below.

All documentation should be mailed (US Postal Service; email will not be accepted/considered) to the following address:

Attention: CBD Program Manager

1719 6th Avenue South

Civitan International Research Center, Suite 312

Birmingham, AL 35294

**Please understand and make note, your information will not be forwarded to the CBD Treatment Approval Committee for review until you have submitted all the required documentation. Packets are reviewed for CBD treatment consideration on a first come, first serve basis.**

Once your records have been reviewed, you will be contacted (either by phone or mail) to inform you about the decision and discuss the next steps. You and your referring neurologist will both receive written notification of the CBD Treatment Approval Committee’s decision.

Study visits

For all participants, CBD will be adjusted according to a schedule with a goal of controlling their seizures. The first patient visit will be lengthy, up to 5 hours. It is anticipated that subsequent visits will follow every two weeks for the first 10 weeks, then followed at month 4, and again at month 6. Patients will then be evaluated quarterly with additional visits scheduled as needed.

Contact

For questions about participation in the study, please contact the UAB Cannabidiol Program at 205-975-8883.