[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lennox-gastaut-syndrome-lgs\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lennox-gastaut-syndrome-lgs":91},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,43,75,105,129],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100636682","sleep-driven-adaptive-neuromodulation-in-lennox-gastaut-syndrome-100636682",false,"NCT07568860","Sleep-Driven Adaptive Neuromodulation in Lennox-Gastaut Syndrome","ADAPT LGS","Inclusion Criteria:\n\n* 18-65 years of age\n* Diagnosis of Lennox-Gastaut Syndrome (LGS) with confirmed generalized seizures, including generalized tonic or tonic-clonic (GTC) seizures. Participants may also have complex partial, atypical absences or atonic seizures, but these will not count toward minimum seizure frequency eligibility.\n* Diagnosis is based on prior video EEG confirmation performed in the last 3 years. Scalp EEG showing slow spike-wave discharges and paroxysmal fast activity.\n* At least four seizures per month (GTC or tonic) on average during the three months preceding enrollment.\n* Medically intractable epilepsy, defined as failure to achieve acceptable seizure control despite trials of at least two antiseizure medications (ASMs).\n* Nonlocalized seizures, as determined by standard diagnostic studies.\n* Stable doses of two or more ASMs for at least one month prior to enrollment (rescue benzodiazepines for acute seizure clusters permitted).\n* Participants with vagus nerve stimulation (VNS) must have stable settings for at least two months prior to enrollment and throughout the study.\n* Subjective reporting of sleep disturbances.\n* Participant or legal guardian can provide informed consent and maintain an online seizure log, alone or with assistance.\n* Participant is willing to remain on a stable ASM regimen (except use of variable dose of rescue medications permitted) throughout the study and able to attend scheduled clinic visits.\n* Reliable caregiver is available to assist with seizure diary maintenance.\n\nExclusion Criteria:\n\n* Predominant seizure type is focal-onset seizures.\n* Anatomical brain abnormalities precluding DBS implantation, or discrete brain lesions on MRI (e.g., cortical malformation, tuber, or sclerosis).\n* Unable to obtain brain MRI due to metal that is not compatible with 3T MRI.\n* History of psychogenic non-epileptic seizures or unstable psychiatric disorders, including suicidal ideation or intent within the last six months.\n* Clinically significant medical conditions increasing risk for pre- or postoperative complications (e.g., significant cardiac or pulmonary disease, uncontrolled hypertension).\n* Participant is pregnant or plans to become pregnant during the study.\n* Participation in another therapeutic investigational drug or device study.\n* Requirement for diathermy treatments during physical or occupational therapy.\n* In the opinion of the investigator or eligibility adjudication committee, the subject is unsuitable for the procedure.","ALL","18 Years","65 Years",{"count":20,"type":21},4,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to explore a new type of personalized brain stimulation that works during day time and night time hours using the Medtronic Percept Deep Brain Stimulation (DBS) device in patients with Lennox-Gastaut Syndrome. The main question(s) this study aims to answer is:\n\n1. Does using the personalized DBS reduce motor seizures compared to conventional DBS?\n2. Is the number of seizures reported by caregivers different for patients using the personalized DBS?\n3. How often do patients using the personalized DBS experience undesired side effects?\n\nResearchers will compare the personalized DBS that works night time, personalized DBS device that works during the day time, and conventional DBS.\n\nParticipants will:\n\n1. Have their seizures and sleep patterns recorded for 3-months\n2. Assess their neurocognitive function\n3. Answer questionnaires about communication, movement, and sleep quality\n4. Wear a sleep headband and seizure warning watch for 5 nights\n5. Complete a mood and sleep assessment\n6. Have a 3T and possibly 7T MRI\n7. Be implanted with stereo-encephalography and undergo 3\\~5 days of monitoring\n8. Have the stereo-encephalography taken out\n9. Receive DBS implantation through surgery and have several months of stimulation and no stimulation periods\n10. Have routine clinical visits to check on healing after surgery\n11. Have their caregiver help them keep a dairy about their seizures, sleep and quality of life",[27,28],"Lennox Gastaut Syndrome (LGS)","Epilepsy",[30],"deep brain stimulation","NOT_YET_RECRUITING","2026-05-06",{"date":34,"type":35},"2026-05-08","ACTUAL",{"date":37,"type":21},"2026-10-01",{"date":39,"type":21},"2031-09-30",{"name":41,"class":42},"University of Minnesota","OTHER",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100587107","the-childrens-adaptive-deep-brain-stimulation-for-epilepsy-trial-100587107","NCT06924086","The Children's Adaptive Deep Brain Stimulation for Epilepsy Trial","The Children's Adaptive Deep Brain Stimulation for Epilepsy Trial (CADET): a Pivotal, Randomized, Controlled, Double-blinded Multi-site Clinical Trial of Deep Brain Stimulation to Treat Children With Lennox-Gastaut Syndrome","CADET","Children enrolled in this study must:\n\n* Be 5-14 years of age at consent.\n* Have a diagnosis of LGS, as determined by:\n\n  * Slow (\\\u003C3.0Hz) spike-and-wave pattern and\u002For fast wave pattern (tonic seizures) detected on EEG at least six-months prior to the enrolment into the baseline period\n  * History of drop seizures (tonic, atonic, or tonic-clonic) that precedes at least six-months prior to the enrolment into the baseline period\n* Have experienced at least 10 seizures in the four weeks prior to enrolment.\n* Have tried and not responded to two or more antiseizure medications prior to enrolment.\n* Be taking one or more anti-seizure medication(s) at a stable dose for at least the four weeks prior to enrolment.\n* Have a carer who is willing for their child's maintenance anti-seizure medications and ketogenic diet (if relevant) to be unaltered for the trial duration.\n* Have a carer who is willing and able to comply with all the requirements of the study, including the completion of the seizure diary and periodic device charging.\n\nChildren enrolled in this study must not:\n\n* Have received prior deep brain stimulation insertion.\n* Have an active ('on') vagus nerve stimulator (or active within the six months prior to the baseline period).\n* Have had a change in their anti-seizure medication prescription or stopped their ketogenic diet within the last 4 weeks\n* Have started or made changes to the prescription of a ketogenic diet within the last 12-weeks\n* Have abnormal thalamic anatomy detected on imaging that would render DBS either unsafe or unfeasible.\n* Have a bleeding disorder(s).\n* Have a medical condition(s)\u002Ffactor(s) that would increase their anaesthetic risk to an unacceptable level.\n* Have a nickel allergy.\n* Be pregnant.","5 Years","14 Years",{"count":54,"type":21},22,[24],"The CADET Trial will investigate the effectiveness of deep brain stimulation (DBS) to reduce the frequency of seizures in children with Lennox-Gastaut syndrome (LGS). The CADET Trial will use a non-CE\u002FUKCA marked device - the Picostim DBS system.\n\nThe SMART-DBS study is a sub-study of the CADET Trial. SMART-DBS will investigate the application of adaptive DBS for the treatment of children with LGS. Children will be recruited after they exit from either the prior 'CADET Pilot Study' or 'CADET Trial' - meaning that these children will already be receiving therapy with an already implanted Picostim device.",[27],[59,30,60,61,62,63],"epilepsy","Lennox-Gastaut Syndrome","pediatric","paediatric","children","RECRUITING","2026-04-01",{"date":67,"type":35},"2026-04-07",{"date":69,"type":35},"2026-03-24",{"date":71,"type":21},"2028-01-31",{"name":73,"class":42},"University College, London",1,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":83,"maxAge":17,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":88,"conditions":89,"keywords":92,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":74},"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.","2 Years",{"count":85,"type":21},25,[87],"PHASE4","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",[90,91],"Dravet Syndrome (DS)","Lennox-Gastaut Syndrome (LGS)",[93,94,95,28,91,90],"Cannabidiol (CBD)","Epidiolex","Seizures","2026-03-13",{"date":98,"type":35},"2026-03-17",{"date":100,"type":21},"2026-06-01",{"date":102,"type":21},"2029-06",{"name":104,"class":42},"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":117,"conditions":118,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"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,[24],"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.",[90,27],"2025-11-03",{"date":121,"type":35},"2025-11-06",{"date":123,"type":21},"2025-12-15",{"date":125,"type":21},"2026-12-31",{"name":127,"class":128},"Byteflies","INDUSTRY",{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":16,"minAge":83,"maxAge":136,"enrollmentInfo":137,"targetDuration":4,"studyType":22,"phases":138,"briefSummary":141,"conditions":142,"keywords":143,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":74},"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},[139,140],"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.",[91,90],[144,145],"CBD","transdermal","2024-12-13",{"date":148,"type":35},"2024-12-18",{"date":150,"type":21},"2025-01",{"date":152,"type":21},"2027-01",{"name":154,"class":42},"Alexander Rotenberg"]