Transdermal CBD for Epilepsy

Overseen By Clinical Research Manager

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Alexander Rotenberg

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study is a preliminary open-label, single-arm Phase II investigation into the safety and efficacy of transdermal cannabidiol (CBD) delivered using GT4 skin bream technology in individuals diagnosed with Dravet and/or Lennox-Gastatu syndrome (DS and/or LGS). We aim to enroll 25 participants between the ages of 2 and 55 diagnosed with DS and/or LGS. Transdermal delivery of cannabinoids may provide advantages over other traditional routes of administration. Noted advantages include avoidance of first pass metabolism which mitigates potentially dangerous drug-drug interactions due to delayed cannabinoid accumulation, and more stable and constant plasma cannabinoid concentrations. GT4 technology, uses emulsion technology containing penetrating agents, basement membrane disruptors, and vasodilators to overcome hydrophilic and lipophilic structures to open channels and transport cannabinoids deep into the dermis layer of the skin. Once in the dermis, vasodilators dilate the capillary bed to increase fluid dynamic flow into and out of the application site, delivering cannabinoids into the blood stream. The primary objective is to investigate the safety and efficacy of CBD delivery with the A-Synaptic GT4 Transdermal Delivery System in individuals diagnosed with DS and/orLGS. Dr. Rotenberg will apply for and hold the expanded access IND for this study, as the sponsor is running this study as an investigator-initiated study. The study consists of 11 visits over \~160 days, dosing begins at Visit #2.

Research Team

Alexander Rotenberg, MD, PhD

Principal Investigator

Boston Children's Hospital

Eligibility Criteria

This trial is for individuals aged 2 to 55 with Dravet Syndrome (DS) and/or Lennox-Gastaut Syndrome (LGS), which are forms of epilepsy. Participants must be diagnosed with one or both conditions to qualify.

Inclusion Criteria

I had 4 or more seizures in the last 28 days.

My non-drug treatments have been the same for the last 4 weeks and I can keep them stable.

Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study

Exclusion Criteria

I have or had a thyroid condition.

I have not had major surgery in the last 3 months and have no plans for surgery during the study.

I needed revival from a severe lack of oxygen in the last 6 months.

Treatment Details

Interventions

• CBD: GT4 Transdermal Delivery System (Cannabinoid)

Trial Overview The study tests a new way to deliver CBD through the skin using GT4 technology in patients with DS and/or LGS. It aims to see if this method is safe and works well by providing stable CBD levels in the blood without traditional drug interactions.

Participant Groups

Group I: Active Therapy Experimental Treatment 1 Intervention

CBD: GT4 Transdermal Delivery System

Who Is Running the Clinical Trial?

Alexander Rotenberg

Lead Sponsor

Trials

1

Recruited

30+

A-Synaptic

Collaborator

Trials

1

Recruited

30+