CBD Delivery with the A-Synaptic GT4 Transdermal Delivery System in with Dravet Syndrome And/or Lennox-Gastaut Syndrome

Phase 1 & 2

Waitlist Available

Led By Alexander Rotenberg, MD, PhD

Research Sponsored by Alexander Rotenberg

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

1. Males and females between the age of 2-55 years, inclusive

2. Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation), have been post-menopausal for at least 1 year prior to screening, or have not reached menarche Or

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 112 days

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed, transdermal CBD could potentially cause skin irritation at the application site, allergic reactions, fatigue, changes in appetite or weight, diarrhea, or affect liver enzymes.