Back to search results

CBD Delivery with GT4 Transdermal System for Dravet and Lennox-Gastaut Syndromes

This study is looking at a new way to deliver cannabidiol (CBD) using a skin patch called the GT4 Transdermal Delivery System. It's for people aged 2 to 55 who have Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS). Researchers want to see how safe and effective this CBD skin patch is. Delivering CBD through the skin might avoid some problems with other ways of taking medicine, like drug interactions, and could lead to more steady levels of CBD in the body. The study will enroll 25 participants and will measure how well people use the patch and any side effects over 112 days.

Study design
This is a preliminary open-label, single-arm Phase II study, meaning all 25 participants will receive the CBD GT4 Transdermal Delivery System. There is no comparison group or blinding.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 112 days to assess compliance and any side effects.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06738732

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

Not Yet Recruiting
PHASE1Ages 2–55InterventionalTreatment
Alexander Rotenberg
~25 participants
Updated 2024-12-18 on ClinicalTrials.gov
What's tested:CBD: GT4 Transdermal Delivery System

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Compliance
Measured over 112 Days
+1 more outcome measured

Conditions

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

Explore related trials

Developmental and Epileptic Encephalopathy 6ALennox-Gastaut Syndrome

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Alexander Rotenberg, MD, PhD · PRINCIPAL_INVESTIGATOR · Boston Children's Hospital

Who to contact

Clinical Research Manager
[email protected]
617-919-4617
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
Double-barrier method
Intrauterine devices
Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
Vasectomy of partner at least 6 months prior to screening
Abstinence and agrees to use contraception if planning on becoming sexually active 3. 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 4. Reported ≥4 countable seizures during the 28-day run in period 5. Participants taking ≥1 AED at a stable dose for ≥4 weeks prior to screening, and participants and/or caregivers willing to maintain dose for duration of study period 6. Non-pharmacological therapies (e.g., vagus nerve stimulation, ketogenic diet, modified Atkins diet) stable for ≥4 weeks prior to screening, and participants and/or caregivers willing to maintain a stable regimen for the duration of the study period 7. 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 8. Otherwise healthy as determined by medical history, laboratory results, electroencephalogram (EEG), vital signs, and physical examination, as assessed by the QI/MD

What this trial measures

  • Compliance112 Days

    Proportion of participants compliant with study dosing regimen for visits at baseline, 7, 14, 21, 28, 56, 84, and 112 days post treatment;

  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]112 Days

    Pre-emergent and post-emergent adverse events will be described in separate frequency tables. The description, frequency, type, severity, causality, and outcome of each adverse event will also be listed.