A Mobile Health Application to Detect Absence Seizures Using Hyperventilation and Eye-Movement Recordings
This study is being done to find out if a smartphone app can identify absence seizures. Children who have a history of absence seizures, as well as children without any seizure history, will be testing out the app. If participating the child will be guided through hyperventilation, an activity that asks the child to take quick, deep breaths. The app will record video of the child's face and sounds they make during hyperventilation. Hyperventilation is a safe and established technique frequently used during EEG (electroencephalogram) to encourage seizure occurrence. The App will be used during a regularly scheduled EEG.
NCT06093490 — Seizures
Status: Recruiting
http://inclinicaltrials.com/seizures/NCT06093490/
Safety and Efficacy of CBD (Epidiolex) in Idiopathic Generalized Epilepsy With Typical Absence Seizures
This is a Pilot study, open-label study consisting of a screening period of up to 4 weeks, a 4-week dose-titration treatment period to dose of up to 20 mg/kg/day BID of CBD (Epidiolex), and a 30 day safety follow-up period following the last dose of study medication.
NCT04899050 — Study the Efficacy of Epidiolex for Typical Absence Seizures
Status: Completed
http://inclinicaltrials.com/study-the-efficacy-of-epidiolex-for-typical-absence-seizures/NCT04899050/
Detecting Absence Seizures Using Eye Tracking
The goal of this study is to develop a comfortable system that uses a wearable eye-tracker similar to eyeglasses to assist people with epilepsy in counting and measuring the severity of seizures. Participants will wear an eye-tracker during a routine EEG.
NCT04439656 — Seizures
Status: Completed
http://inclinicaltrials.com/seizures/NCT04439656/
A Phase 2a, Safety, Tolerability, Pharmacokinetics, and Quantitative EEG Study of CX-8998 in Adolescents and Adults With Idiopathic Generalized Epilepsy With Absence Seizures
This is a Phase 2a, open-label study consisting of a screening period of up to 4 weeks and a 4-dose-titration treatment period to a dose of up to 10 mg twice daily (BID) of CX-8998, followed by a 1-week safety follow-up period after the last dose of study medication.
NCT03406702 — Epilepsy
Status: Completed
http://inclinicaltrials.com/epilepsy/NCT03406702/
A Phase 2, Open-label, Dose-finding Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution in Pediatric Patients With Treatment-Resistant Childhood Absence Seizures
The primary purpose of this study is to assess the efficacy of Cannabidiol Oral Solution in the treatment of pediatric participants with treatment-resistant childhood absence seizures. This study will also assess safety, tolerability and pharmacokinetics of Cannabidiol Oral Solution, and any improvement in qualitative assessments of participant status over the duration of the study in pediatric participants with treatment-resistant childhood absence seizures. The study will include a 4-week Screening Period, a 5 or 10 day Titration Period (depending study Cohort), a 4-week Treatment Period followed by 5-day Tapering for doses >20 mg/kg/day and a 4-week Follow-up Period.
NCT03336242 — Childhood Absence Epilepsy
Status: Terminated
http://inclinicaltrials.com/childhood-absence-epilepsy/NCT03336242/
A Multi-center, Uncontrolled, Open-label, Evaluation of Lamotrigine Monotherapy on Newly Diagnosed Typical Absence Seizures in Children and Adolescents
This is a multi-center, uncontrolled, open-label study to evaluate the efficacy and safety of lamotrigine monotherapy on newly diagnosed typical absence seizure in children and adolescents in Japan and South Korea. The study period is composed the baseline, fixed escalation phase, escalation phase, maintenance phase, taper phase, and post study examination. During the fixed escalation phase, the investigational product is administered at 0.3 mg/kg/day for 2 weeks (Week 1 to 2), followed by 0.6 mg/kg/day for 2 weeks (Week 3 to 4). Subjects thereafter visit the clinic once every 1 to 2 weeks during the escalation phase to increase the dose by 0.6 mg/kg/day up to a maximum of 10.2 mg/kg/day or 400 mg/day (whichever was less) until patients are confirmed to be seizure-free by HV tests for clinical signs. After seizure free is confirmed by HV-clinical signs, the dose is increased by one level and HV-EEG (electroencephalography) test (first test) is assessed at the next visit. If seizure free is observed by HV-EEG, the same dose is administered. Thereafter, HV-EEG (second test) is assessed at the next visit and if seizure free is confirmed again, the subjects enter the 12-week maintenance phase. During the maintenance phase, patients visit the clinic once every 4 weeks. The dose can be adjusted as necessary within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day (whichever was less) taking into account the status of seizures and the safety. The investigational product is administered once daily (in the evening). However, if the number of tablets is large, twice-daily administration (in the morning and evening) is also allowed. After the completion of maintenance phase, subjects who have responded to lamotrigine without tolerability issues are eligible to enter the extension phase of the study if clinically indicated.
NCT01431976 — Epilepsy
Status: Completed
http://inclinicaltrials.com/epilepsy/NCT01431976/
Magnetoencephalography in Absence Seizures
Background: - An absence seizure is a type of seizure that usually begins in childhood and goes away by early adulthood. Scientists do not yet know where absence seizures begin in the brain. Some evidence suggests that these seizures begin in the thalamus, a structure deep in the brain, but other studies suggest that they begin in the frontal cortex, at the front part of the brain. - Magnetoencephalography is a type of brain scanning procedure that is useful in determining information about what happens to the brain during epileptic seizures. Understanding where absence seizures come from may help doctors find new treatments for them. Objectives: - To gain a better understanding of which parts of the brain are affected in absence seizures. Eligibility: - Patients 7 to 35 years of age who have been diagnosed with absence seizures. Design: - Procedures are for research purposes only, not to diagnose or treat a particular medical condition. - Two outpatient visits to the National Institutes of Health Clinical Center: evaluation and scanning. - Researchers will evaluate potential participants with a medical history, physical examination, and electroencephalography (EEG). These tests will be performed under another protocol, 01-N-0139. - Patients will undergo magnetoencephalography (MEG) and magnetic resonance imaging (MRI) of the brain. The study procedures will be performed one time; however, an MEG or MRI scan may need to be repeated for technical reasons. Researchers will not do more than two MEG or MRI scans. - The MEG will record very small magnetic field changes produced by the activity of the brain. An EEG will be recorded at the same time as the MEG. - The MRI will use a magnetic field to take pictures of the inside of the brain. - The MEG will take 3 hours to complete (2 hours for preparation, 1 hour in the scanner). The MRI will take approximately 1 hour.
NCT00884351 — Seizures
Status: Completed
http://inclinicaltrials.com/seizures/NCT00884351/
Evaluation of Lamotrigine in Subjects With Absence Seizures
This is an open-label study evaluating the efficacy and safety of lamotrigine (LTG) for the treatment of newly-diagnosed typical absence seizures. Subjects will be children and adolescents < 13 years of age. It will be conducted at multiple sites in the US. The study will consist of 4 phases: Screen Phase (up to 1 week), Baseline Phase (24 hours), Escalation Phase (up to 20 weeks) and Maintenance Phase (12 weeks). Subjects will receive increasing doses of LTG according to the dosing schedule until attaining seizure freedom as confirmed by hyperventilation (HV) for clinical signs and a 1-hr EEG at 2 consecutive weekly visits. At that point, subjects will move into the 12-week Maintenance Phase. Subjects who do not achieve seizure freedom upon reaching the maximum dose (10.2mg/kg/day) with the specified dose escalation will be discontinued from the study. During the Maintenance Phase, the investigators will use their best effort to maintain the subjects at the efficacious dose reached. If the subjects have unacceptable side effects or inadequate seizure control, the doses of study drug can be increased or decreased as specified in the dosing schedule. Safety will be assessed by monitoring adverse events, laboratory assessments, and serum lamotrigine levels. Health outcomes assessments will also be conducted.
NCT00144872 — Seizure, Absence
Status: Completed
http://inclinicaltrials.com/seizure-absence/NCT00144872/
Mutual Interactions Between Absence Epilepsy Seizures and the Integration of Sensory Stimuli
Epileptic seizures arise from neuronal defects that often alter the capacity of the brain to process sensory information. During absence seizures, a frequent epileptic syndrome in children, the normal conscious and perceptual processes are temporarily interrupted. This is the result of abnormal synchronized neural activities in the thalamo-cortical loops, leading to bilateral spike-and-wave discharges (SWDs) in the cortical electroencephalograms (EEGs). The brain mechanisms underlying the lack of sensory experience during absence seizures are disputed. Based on preliminary data, the investigators hypothesize that the alternation of 'spike' and 'wave' patterns during seizure could cause a time-to-time inconstancy in cortical responsiveness, preventing conscious perception. Using a real-time closed-loop stimulation system, the investigators will research how the S- and W-patterns specifically alter the sensory-evoked responses in the EEG. During a standard EEG, visual stimulations will be applied between and during absence seizures to test the hypothesis that repeated sensory stimuli, applied with an appropriate timing relative to the seizure-related oscillatory cycle, could negatively interfere with the regenerative network mechanisms involved in the occurrence of SWDs. The completion of this project should permit to unveil a new neuronal mechanism supporting the lack of conscious experience during absences and pave the way for new clinical non-invasive strategies to interrupt ongoing seizure activity.
NCT03676543 — Childhood or Juvenile Absence Epilepsy
Status: Terminated
http://inclinicaltrials.com/childhood-or-juvenile-absence-epilepsy/NCT03676543/
A Multicenter, Open-Label, Flexible Dose Study to Assess the Long-Term Safety of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution in Pediatric Patients With Treatment-Resistant Childhood Absence Seizures
The primary purpose of this study is to assess the long-term safety and tolerability of Cannabidiol Oral Solution (CBD) in pediatric participants with treatment-resistant childhood absence seizures.
NCT03355300 — Childhood Absence Epilepsy
Status: Terminated
http://inclinicaltrials.com/childhood-absence-epilepsy/NCT03355300/