Transdermal CBD for Epilepsy
Trial Summary
Will I have to stop taking my current medications?
Participants must be on a stable dose of at least one anti-epileptic drug (AED) for at least 4 weeks before the study and must maintain this dose during the study. However, if you are taking more than four AEDs or any other medications that might affect the study, you may need to stop or adjust them as assessed by the study doctor.
What data supports the effectiveness of the drug GT4 Transdermal Delivery System for epilepsy?
Research shows that CBD, the active ingredient in the GT4 Transdermal Delivery System, has been effective in reducing seizures in people with treatment-resistant epilepsy. Studies have demonstrated that CBD can lead to significant improvements in seizure frequency, with some patients becoming seizure-free or experiencing more than a 50% reduction in seizures.12345
Is transdermal CBD safe for humans?
How is the GT4 Transdermal Delivery System for CBD different from other epilepsy treatments?
The GT4 Transdermal Delivery System for CBD is unique because it delivers CBD through the skin, which may offer a more consistent absorption compared to oral formulations that have variable bioavailability. This method could potentially reduce the side effects associated with oral CBD, such as gastrointestinal issues, by bypassing the digestive system.1391011
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive transdermal CBD using the GT4 system, with dosing beginning at Visit #2
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- CBD: GT4 Transdermal Delivery System
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alexander Rotenberg
Lead Sponsor
A-Synaptic
Collaborator