CBD Delivery with the A-Synaptic GT4 Transdermal Delivery System in with Dravet Syndrome And/or Lā¦ (NCT06738732) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
CBD Delivery with the A-Synaptic GT4 Transdermal Delivery System in with Dravet Syndrome And/or Lennox-Gastaut Syndrome
United States25 participantsStarted 2025-01
Plain-language 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 can participate
Age range2 Years ā 55 Years
SexALL
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Inclusion criteria
ā. Males and females between the age of 2-55 years, inclusive
ā. 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,
ā. Clinically confirmed and documented diagnosis of refractory DS and/or LGS. Documentation of diagnosis must be provided by a neurologist, pediatrician, or primary care practitioner
ā. Reported ā„4 countable seizures during the 28-day run in period
ā. Participants taking ā„1 AED at a stable dose for ā„4 weeks prior to screening, and participants and/or caregivers willing to maintain dose for duration of study period
ā. Non-pharmacological therapies (e.g., vagus nerve stimulation, ketogenic diet, modified Atkins diet) stable for ā„4 weeks prior to screening, and participants and/or caregivers willing to maintain a stable regimen for the duration of the study period
ā. Adults to provide voluntary, written, informed consent to participate in the study. If under the age of consent or unable to consent due to cognitive impairment, the participant and the participant's parent(s), legal guardian(s), or caregiver(s) to provide voluntary, written, informed assent and consent, respectively, for participation in the study
What they're measuring
1
Compliance
Timeframe: 112 Days
2
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
ā. Otherwise healthy as determined by medical history, laboratory results, electroencephalogram (EEG), vital signs, and physical examination, as assessed by the QI/MD
Exclusion criteria
ā. Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
ā. Allergy, sensitivity, or intolerance to the investigational product's active and/or inactive ingredients
ā. Acute or chronic skin disease (e.g., atopic dermatitis, eczema, rosacea, psoriasis) or dermatological conditions (scars, moles, etc.) in the proposed area of application that may interfere with the application and absorption of the investigational product, as assessed by the QI/MD
ā. Etiology of participant seizures is related to progressive neurologic disease, as assessed by the QI/MD.
ā. Currently prescribed \>4 concurrent AEDs
ā. Current unstable significant psychiatric or psychological condition (e.g., schizophrenia, bipolar disorder, clinical depression, eating disorders) and/or history of suicidal behavior or any suicidal ideation as assessed by the C-SSRS at screening, as appropriate, as assessed by the QI/MD (See Section 9.13.2)
ā. History of psychosis in immediate family including schizophrenia and affective psychosis
ā. Anoxic episode requiring resuscitation in the past 6 months