[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"dravet-syndrome-ds\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:dravet-syndrome-ds":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,48,76,105,131],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100644898","early-phase-1-a-study-to-evaluate-the-safety-and-pharmacokinetics-of-rc001-in-children-with-dravet-syndrome-100644898",false,"NCT07675746","A Study to Evaluate the Safety and Pharmacokinetics of RC001 in Children With Dravet Syndrome","An Investigator-Initiated Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RC001 in Patients With Dravet Syndrome Aged 2 to 18 Years","Inclusion Criteria:\n\n1. Patients aged 2-18 years with Dravet syndrome caused by SCN1A mutations, with onset before 12 months of age characterized by focal seizures, hemiclonic seizures, generalized tonic-clonic seizures, or myoclonic seizures, and with MRI excluding progressive neurological disease either historically or at screening. Enrolled participants will be assigned as follows: 1 participant aged 13-18 years, 1 aged 7-12 years, and 1 aged 2-6 years will undergo intra-subject dose escalation; 5 participants aged 2-12 years will receive fixed-dose multiple administrations.\n2. Seizure frequency requirements: at least 6 cumulative seizures within 12 weeks prior to the day of signing the ICF, and at least 2 seizures within 4 weeks prior to ICF signing. For participants in Stage 2 (fixed-dose multiple administration), seizure frequency must also be ≥4 within 4 weeks after ICF signing.\n3. Documented pathogenic or likely pathogenic variants in the SCN1A gene associated with Dravet syndrome.\n4. Prior treatment with at least one anti-epileptic intervention, including anti-seizure medications (ASM), ketogenic diet, or vagus nerve stimulation (VNS), with inadequate seizure control or discontinuation due to adverse events (AEs).\n5. Use of at least one ASM prior to screening, with a stable dose for at least 4 weeks before screening.\n6. All epilepsy-related treatments, including ASM and other interventions (ketogenic diet and VNS), must be stable for at least 4 weeks prior to screening and are expected to remain stable throughout the study (medications adjusted by body weight are allowed).\n7. Willingness to participate and provision of written informed consent.\n\nExclusion Criteria:\n\n1. Presence of other known pathogenic gene mutations causing Dravet syndrome, or SCN1A gain-of-function mutations reported in the literature and\u002For experimentally validated, including but not limited to: Ala23Glu, Thr162Ile, Thr226Met, Ser228Pro, Val229Leu, Ile236Val, Ile236Thr, Val250Leu, Leu263Val, Thr398Met, Ala420Val, Val422Leu, Ile883Thr, Leu893Phe, Ala989Thr, Thr1174Ser, Trp1204Arg, Ala1339Asp, Pro1345Ser, Pro1345Leu, Ser1346Pro, Ile1347Val, Val1481Ile, Ile1483Met, Gln1489Lys, Ile1498Thr, Ile1498Met, Phe1499Leu, Met1500Val, Arg1575Cys, Val1611Phe, Leu1624Pro, Arg1636Gln, Arg1648Cys, Leu1649Gln, Leu1660Ile, Phe1661Leu, Ala1669Glu, Leu1670Trp, Gly1674Arg, Phe1774Ser, Asp1866Tyr.\n2. Current maintenance treatment with anti-epileptic drugs primarily acting as sodium channel blockers, including but not limited to carbamazepine, oxcarbazepine, lamotrigine, lacosamide, or rufinamide.\n3. Ongoing neuromodulation therapy (e.g., responsive neurostimulation or deep brain stimulation), excluding vagus nerve stimulation (VNS).\n4. Receipt of gene therapy or cell therapy within 1 year prior to screening.\n5. Receipt of any vaccination within 12 weeks prior to screening.\n6. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>2× the upper limit of normal (ULN), or total bilirubin \\>1.5× ULN; renal insufficiency or serum creatinine \\>1.2× ULN.\n7. Presence of any severe uncontrolled disease other than Dravet syndrome.\n8. History of autoimmune disease, or uncontrolled infectious disease within 1 week prior to screening.\n9. History of brain or spinal cord disease (other than epilepsy, Dravet syndrome, or trauma), or history of bacterial meningitis.\n10. Spinal deformity or other conditions that may interfere with normal cerebrospinal fluid (CSF) flow, or implantation of a CSF shunt.\n11. Pregnant or breastfeeding females.\n12. Any other significant disease or condition that, in the investigator's judgment, may pose a risk to the patient, interfere with study results, or affect the patient's ability to participate in the study.","ALL","2 Years","18 Years",{"count":20,"type":21},8,"ESTIMATED","INTERVENTIONAL",[24],"EARLY_PHASE1","This is an open-label, single-center study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of intrathecal RC001 in patients with Dravet syndrome aged 2 to 18 years. The study includes a dose-escalation part followed by a fixed dose treatment part, with participant progression based on investigator-assessed safety and efficacy.",[27],"Dravet Syndrome (DS)",[29,30,31,32,33,34],"Dravet syndrome","Developmental and epileptic encephalopathy","RC001","Oligonucleotide drugs","ADAR RNA editing","SCN1A gene","RECRUITING","2026-06-23",{"date":38,"type":39},"2026-06-30","ACTUAL",{"date":41,"type":39},"2025-12-22",{"date":43,"type":21},"2027-12-31",{"name":45,"class":46},"Second Affiliated Hospital of Guangzhou Medical University","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":47},"100562075","phase-4-assessment-of-safety-of-the-use-of-fenfluramine-in-children-with-dravet-syndrome-under-24-months-of-age-100562075","NCT06598449","Assessment of Safety of the Use of Fenfluramine in Children With Dravet Syndrome Under 24 Months of Age","Assessment of Safety of the Use of Fenfluramine in Children With Dravet Syndrome Under the Age of 24 Months","Inclusion Criteria:\n\nTreating physicians must submit a clinical statement of potential benefit, which includes patient's gender, age, diagnosis, genetic pathogenic variant, co-morbidities, seizure history, prior and current therapies, response to prior therapies and reason for request. Echocardiogram (ECHO) results must also be submitted to the lead site prior to final approval. Patients must be between 12 and 23 months old to be eligible. Additional inclusion criteria:\n\n1. SCN1A with a known or presumed pathogenic variant or VUS with a history of prolonged seizure or a clinical diagnosis of Dravet syndrome.\n2. Failure of at least one anti-seizure medication that is not a sodium channel blocker (lamotrigine, oxcarbazepine, carbamazepine, eslicarbazepine)\n\nExclusion Criteria:\n\n1. Patients with mild or greater mitral valve regurgitation and\u002For trace or greater aortic valve regurgitation will not be eligible for participation. The clinical statement can be submitted first for initial, conditional approval and then ECHO results can be submitted at a later date for final approval.\n2. Patients with failure to thrive will not be eligible for participation as fenfluramine can suppress appetite and has a risk for weight loss. Failure to thrive will be evaluated on the following criteria:\n\n   1. Weight less than the 2nd percentile.\n   2. Lack of weight gain that crosses two or more of the major percentile lines and is not congruent with length.","12 Months","24 Months",{"count":5,"type":21},[59],"PHASE4","Dravet syndrome is a genetic epilepsy associated with pathogenic variants in SCN1A that codes for Nav1.1, a protein necessary for sodium channels. Children with Dravet syndrome classically present in the first year of life with prolonged seizures, often hemiclonic and in the setting of fever or temperature changes such as getting in or out of bath water. Many anti-seizure medications are sodium channel blockers and exacerbate seizures in this patient population. This creates some limitations in medication choices for this patient population. Recently fenfluramine was approved for use in Dravet syndrome for people 2 years and older. Randomized studies demonstrated a 74.9% reduction of convulsive motor seizures compared to 19.2% in the placebo group. Additionally, 16% of children treated with fenfluramine were seizure free. Fenfluramine is likely to be as effective in children under the age of 2 years. The current study has proposed an intermediate size patient population expanded access protocol to allow access to fenfluramine for children under 24 months of age.",[27,62],"Children Under 2 Years",[64,65,66],"Fenfluramine","Dravet Syndrome","Children under 2 years","2026-05-13",{"date":69,"type":39},"2026-05-15",{"date":71,"type":39},"2024-10-22",{"date":73,"type":21},"2027-07",{"name":75,"class":46},"University of Colorado, Denver",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":47},"100587164","phase-4-a-study-to-investigate-the-transition-of-children-from-artisanal-cannabidiol-cbd-to-epidiolex-100587164","NCT06924827","A Study to Investigate the Transition of Children From 'Artisanal\" Cannabidiol (CBD) to Epidiolex","A Clinical Study of the Transition of Children From 'Artisanal' Cannabidiol to Epidiolex","CANN-SWITCH","Inclusion Criteria:\n\n* Male or female aged 2 through 18 years, inclusive.\n* Clinical diagnosis of Dravet or Lennox Gastaut Syndrome:\n\nClinical diagnosis of Dravet Syndrome supported by:\n\n1. Onset of seizures within the first year of life.\n2. Initial seizures present as fever-induced or fever-triggered seizures, hemi-clonic, generalized tonic-clonic, prolonged seizures (more than 15 minutes).\n3. Emergence of other seizure types after 1 year of age.\n4. Normal development within the first year of age, then emergence of neurodevelopmental difficulties or delay.\n\nClinical diagnosis of Lennox Gastaut Syndrome supported by:\n\na. History of an EEG with slow\u002Fdisorganized background and slow (\\\u003C2.5 Hz or less) spike and wave activity or generalized paroxysmal fast activity (GPFA).\n\nb. History of more than 1 type of generalized seizures, including drop seizures (tonic, atonic or tonic-clonic).\n\n* Participant must be willing and able to give written informed consent for participation. If the participant is not qualified or unable to provide written consent based on age, development, intellectual capacity or other factors, the parent or legally authorized representative must provide written informed consent on their behalf.\n* Must be on a stable dose of a licensed artisanal cannabidiol (CBD) product as maintenance therapy for seizure control for a minimum of 3 months prior to screening (visit 1).\n* 'Artisanal' CBD dose must be between 5 mg\u002Fkg\u002Fday and 20mg\u002Fkg\u002Fday.\n* 'Artisanal' CBD preparation must be a high CBD to THC formulation defined as a minimum CBD:THC ratio of 20:1.\n* Must be taking a minimum of 1 other anti-seizure medication (ASM) in addition to an 'artisanal' form of CBD.\n* Must be on a stable dose of ASMs for a minimum of 28 days prior to screening (visit 1) and remain on a stable dose throughout the entire study unless medically necessary change(s) are required for safety events.\n* Participants with a vagal nerve stimulator (VNS) must have the following conditions met:\n\n  1. The VNS has been in place for a minimum of 3 months prior to screening (visit 1).\n  2. The settings have remained constant for 28 days prior to screening (visit 1) and are expected to remain constant throughout the entire study.\n  3. The battery is expected to last for the duration of the study.\n* Participants on the ketogenic diet must be on a stable regime for a minimum of 28 days prior to screening (visit 1) and expected to remain stable throughout the entire study.\n* Participant and\u002For caregiver must be willing to maintain a seizure diary throughout the duration of the study.\n\nExclusion Criteria:\n\n* Previous or current exposure to Epidiolex.\n* Supplemental use of cannabinoid-containing products, including but not limited to:\n\n  1. Recreational use of cannabis.\n  2. Use of artisanal CBD as a seizure rescue medication.\n  3. Use of more than one formulation of 'artisanal' CBD (e.g. THC supplementation).\n* Pregnant or breastfeeding.\n* Any clinically significant, unstable medical condition other than epilepsy that, in the opinion of the investigator, could place the participant at increased risk or interfere with the results of the study.\n* Hepatic impairment at screening (visit 1) defined as either of the following conditions:\n\n  1. ALT or AST \\> 5x upper limit of normal (ULN).\n  2. ALT or AST \\> 3x ULN and total bilirubin \\>2x ULN (or international normalized ratio \\>1.5).\n* Known sensitivity to any ingredient in Epidiolex, including sesame and sesame oil.\n* Unwillingness to refrain from alcohol consumption throughout the duration of the study.\n* Unwillingness of females of childbearing potential to use a highly effective form of birth control. Acceptable methods include: hormonal contraceptives, intra-uterine devices, bilateral tube occlusion, vasectomized partner and sexual abstinence.\n* Currently enrolled in another clinical trial.\n* Have suicidal plan\u002Fintent, active suicidal thoughts, or a suicide attempt in the past 6 month prior to screening.",{"count":85,"type":21},25,[59],"The goal of this clinical trial is to learn the best way to switch children with Lennox-Gastaut Syndrome (LGS) or Dravet Syndrome (DS) taking 'artisanal' (non pharmaceutical-grade) cannabidiol (CBD) to Epidiolex for treatment of seizures. The main questions it aims to answer are:\n\n* How well does a gradual switch from 'artisanal' CBD to Epidiolex work?\n* Does the same dose of Epidiolex as 'artisanal' CBD work best?\n* What side-effects or medical problems do participants have when switching from 'artisanal' CBD to Epidiolex?\n\nResearchers will examine how successful switching from 'artisanal' CBD to Epidiolex is.\n\nParticipants will:\n\n* Gradually increase their dose of Epidiolex and reduce their dose of 'artisanal' CBD until they are taking just Epidiolex\n* Visit the clinic five times over 20 weeks for checkups and tests\n* Keep a diary of their seizures, symptoms and the number of times they use a rescue seizure medication",[27,89],"Lennox-Gastaut Syndrome (LGS)",[91,92,93,94,89,27],"Cannabidiol (CBD)","Epidiolex","Seizures","Epilepsy","NOT_YET_RECRUITING","2026-03-13",{"date":98,"type":39},"2026-03-17",{"date":100,"type":21},"2026-06-01",{"date":102,"type":21},"2029-06",{"name":104,"class":46},"Elizabeth Donner",{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":16,"minAge":113,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":116,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":4},"100610257","clinical-utility-of-reduced-eeg-home-monitoring-in-fenfluramine-titration-for-dravet-and-lgs-100610257","NCT07225231","Clinical Utility of Reduced EEG Home Monitoring in Fenfluramine Titration for Dravet and LGS","Byteflies Real-world Data Study: Assessing the Clinical Utility of Reduced EEG Montage Home Monitoring for Clinician-driven Fenfluramine Titration in Dravet Syndrome and Lennox-Gastaut Syndrome","TETRIS","Inclusion Criteria:\n\n* Patients with a confirmed Dravet syndrome or Lennox-Gastaut syndrome diagnosis who are eligible for Fenfluramine.\n* Patients for which the neurologist decided to prescribe Fenfluramine as a relevant treatment approach and who have not been prescribed Fenfluramine before.\n* Patients or caregivers should be able and willing to maintain a seizure diary e.g. using a digital seizure diary.\n\nExclusion Criteria: Patients who\n\n* Have been diagnosed with or are suspected to have life-threatening conditions that could result in immediate danger;\n* Need to undergo an MRI scan or cardiac defibrillation;\n* Have an active implanted device such as a pacemaker, defibrillator, or vagal nerve, or brain stimulator;\n* Are unable to provide written informed consent, either directly or via a legal guardian.\n* Have known allergy or skin-sensitivity to the materials used in the Byteflies Adhesives\n* Are between 0 and 3 years of age;\n* Are above weight allowing variable titration\n* The patient is on any medication that would be contra-indicated for use with Fenfluramine at the execution of the study eg. LP352 (bexicaserin), loracaserin, monoamine-oxidase inhibitors, SSRIs, SNRIs, tricyclic antidepressants or other serotonergic agonists or antagonists (antipsychotics).\n* Have a prescribed concomitant use of Stiripentol\n* Have any other condition or finding that would compromise the safety of the participant or the quality of the data, or otherwise interfere with achieving the objectives.\n* A history of cardiovascular or cerebrovascular disease, aortic or mitral valve regurgitation diagnosed by echography\n* Patients\u002Fcaregivers who have only reported\u002Fdetected non-motor seizures","3 Years",{"count":115,"type":21},20,[117],"NA","The goal of this real world data study is to evaluate the clinical utility of remote patient monitoring solution (using Byteflies' EpiCare@Home with reduced EEG montage and other vital signs) with Dravet and LGS patients (ages 3 and up with the exclusion of adults above weight allowing variable titration) to identify an optimal Fenfluramine treatment.\n\nPatients will wear one or more small portable and medically certified measuring devices. Through these devices, electroencephalography (EEG) signals, as well as electro-cardiography (ECG), heart rate, respiration rate, and physical activity are measured, which allows the patient's physician to detect potential seizures, and thus gain more insights.\n\nParticipants will be asked to wear the devices three times at home for remote monitoring periods lasting between 3 and 7 consecutive days. The duration of each monitoring period will be determined by the physician based on the type of epilepsy and the frequency of seizures.",[27,120],"Lennox Gastaut Syndrome (LGS)","2025-11-03",{"date":123,"type":39},"2025-11-06",{"date":125,"type":21},"2025-12-15",{"date":127,"type":21},"2026-12-31",{"name":129,"class":130},"Byteflies","INDUSTRY",{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":138,"enrollmentInfo":139,"targetDuration":4,"studyType":22,"phases":140,"briefSummary":143,"conditions":144,"keywords":145,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":47},"100572858","phase-1-cbd-delivery-with-the-a-synaptic-gt4-transdermal-delivery-system-in-with-dravet-syndrome-andor-lennox-gastaut-syndrome-100572858","NCT06738732","CBD Delivery with the A-Synaptic GT4 Transdermal Delivery System in with Dravet Syndrome And\u002For Lennox-Gastaut Syndrome","Preliminary Evaluation of the Safety and Efficacy of CBD Delivery with the A-Synaptic GT4 Transdermal Delivery System in Individuals Diagnosed with Dravet Syndrome And\u002For Lennox-Gastaut Syndrome","Inclusion Criteria:\n\n1. Males and females between the age of 2-55 years, inclusive\n2. 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,\n\n   Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:\n   * 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)\n   * Double-barrier method\n   * Intrauterine devices\n   * Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)\n   * Vasectomy of partner at least 6 months prior to screening\n   * Abstinence and agrees to use contraception if planning on becoming sexually active\n3. Clinically confirmed and documented diagnosis of refractory DS and\u002For LGS. Documentation of diagnosis must be provided by a neurologist, pediatrician, or primary care practitioner\n4. Reported ≥4 countable seizures during the 28-day run in period\n5. Participants taking ≥1 AED at a stable dose for ≥4 weeks prior to screening, and participants and\u002For caregivers willing to maintain dose for duration of study period\n6. Non-pharmacological therapies (e.g., vagus nerve stimulation, ketogenic diet, modified Atkins diet) stable for ≥4 weeks prior to screening, and participants and\u002For caregivers willing to maintain a stable regimen for the duration of the study period\n7. 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\n8. Otherwise healthy as determined by medical history, laboratory results, electroencephalogram (EEG), vital signs, and physical examination, as assessed by the QI\u002FMD\n\nExclusion Criteria:\n\n1. Individuals who are pregnant, breast feeding, or planning to become pregnant during the study\n2. Allergy, sensitivity, or intolerance to the investigational product's active and\u002For inactive ingredients\n3. 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\u002FMD\n4. Etiology of participant seizures is related to progressive neurologic disease, as assessed by the QI\u002FMD.\n5. Currently prescribed \\>4 concurrent AEDs\n6. Current unstable significant psychiatric or psychological condition (e.g., schizophrenia, bipolar disorder, clinical depression, eating disorders) and\u002For history of suicidal behavior or any suicidal ideation as assessed by the C-SSRS at screening, as appropriate, as assessed by the QI\u002FMD (See Section 9.13.2)\n7. History of psychosis in immediate family including schizophrenia and affective psychosis\n8. Anoxic episode requiring resuscitation in the past 6 months\n9. Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI\u002FMD\n10. Type I or Type II diabetes\n11. Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI\u002FMD on a case-by-case basis\n12. History of or current diagnosis with kidney and\u002For liver diseases as assessed by the QI\u002FMD on a case-by-case basis, with the exception of history of kidney stones in participants who are symptom free for 6 months\n13. Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI\u002FMD\n14. Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI\u002FMD\n15. Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable\n16. Individuals with an autoimmune disease or are immune compromised\n17. Self-reported confirmation of a HIV-, Hepatitis B- and\u002For C-positive diagnosis\n18. Self-reported confirmation of blood\u002Fbleeding disorders as assessed by QI\u002FMD\n19. Use of medical or recreational cannabinoid products prior to screening (see Section 7.3). Participants must agree to abstain for the duration of the run-in and study period\n20. Regular use of tobacco or nicotine products in the past 6 months and during the run-in and study period, as assessed by the QI\u002FMD\n21. Alcohol intake average of \\>2 standard drinks per day, as assessed by the QI\u002FMD. Occasional consumers required to abstain for the duration of the run-in and study period\n22. Alcohol or drug abuse within the last 24 months\n23. Current use of any prescribed or over-the counter medications and\u002For supplements that may affect the safety and\u002For efficacy of the investigational product, as assessed by the QI\u002FMD (See Sections 7.3.1 and 7.3.2)\n24. Plans to travel outside country of residence during the study period\n25. Clinically significant abnormal laboratory results, adverse events, or abnormalities in the EEG at screening, as assessed by the QI\u002FMD\n26. Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI\u002FMD\n27. Any other condition, chronic disease, or lifestyle factor, that, in the opinion of the QI\u002FMD, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant","55 Years",{"count":85,"type":21},[141,142],"PHASE1","PHASE2","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\u002For Lennox-Gastatu syndrome (DS and\u002For LGS). We aim to enroll 25 participants between the ages of 2 and 55 diagnosed with DS and\u002For LGS.\n\nTransdermal 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.\n\nThe 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\u002ForLGS. 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.\n\nThe study consists of 11 visits over \\~160 days, dosing begins at Visit #2.",[89,27],[146,147],"CBD","transdermal","2024-12-13",{"date":150,"type":39},"2024-12-18",{"date":152,"type":21},"2025-01",{"date":154,"type":21},"2027-01",{"name":156,"class":46},"Alexander Rotenberg"]