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

Conditions

• Dravet Syndrome (DS)
• Lennox-Gastaut Syndrome (LGS)

Eligibility Criteria

Sex

ALL

Age

2 Years - 55 Years

Healthy Volunteers

Not accepted

Interventions

• CBD: GT4 Transdermal Delivery System — DRUG
  CBD: GT4 Transdermal Delivery System

Study Details

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.

Key Dates

Start date

Jan 31, 2025

Status verified

Nov 2024

Primary completion

Jan 31, 2027

Completion

Jan 31, 2027

Study Design

Enrollment

25 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Active Therapy
  CBD: GT4 Transdermal Delivery System

Primary Outcome Measure

Compliance [ Time Frame: 112 Days ]

Central Contacts

• Clinical Research Manager
  617-919-4617
  [email protected]

Locations (1)

Find similar trials in Boston, MA

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• Assessment of Safety of the Use of Fenfluramine in Children With Dravet Syndrome Under 24 Months of Age
  PHASE4 · Recruiting · University of Colorado, Denver · Aurora, Colorado