Clinical Trials

This is a two-part, multicenter, double-blind, parallel-group, placebo controlled study to evaluate the effect of ZX008 when used as adjunctive therapy for the treatment of uncontrolled seizures in children and adults with Lennox-Gastaut syndrome (LGS).

The purpose of this study is to use micro-electrode (micro-ECoG) grids to record and map information from the brain to compare to the current standard of care - ECoG grids - in processing and decoding the fine motor movements of the hand in patients undergoing long-term monitoring for the surgical treatment of medically-refractory seizure disorder.

This study proposes to assess the efficacy of Cosyntropin Injectable Suspension, 1 mg/mL compared to vigabatrin. Additionally, this study proposes to determine efficacy of combination therapy of Cosyntropin Injectable Suspension, 1 mg/mL and vigabatrin to monotherapy Cosyntropin Injectable Suspension, 1mg/mL in children with new onset infantile spasms (IS).

The purpose of this study is to collect medical information from a group of infants in order to better understand West syndrome. EEG tests are usually ordered when infants have movements that look like seizures or infantile spasms. If there is hypsarhythmia, then the doctors know to give the specific treatment for West syndrome. We would like to see if there is EEG pattern that is always present even before the infantile spasms start and West syndrome diagnosed.

The primary purpose of this study is to investigate the effect on the frequency of all seizures (convulsive and drop) in patients treated with TAK-935 as an adjunctive therapy compared to placebo in the Maintenance Period.

A clinical study to evaluate the effectiveness, safety, and tolerability of adjunctive ganaxolone therapy compared to placebo for the treatment of seizures in children and young adults with genetically confirmed CDKL5 gene mutation.

This research is being done to observe the safety, tolerability, side effects, and effectiveness of the ketogenic diet in people with continuous seizures (status epilepticus) being treated in a neurointensive care unit.

The purpose of this study is to determine whether intravenous immunoglobulin (IVIG) treatment reduces significantly the number of epileptic seizures in cases of autoimmune epileptic seizures.

This study hypothesises that physical exercise in children with epilepsy will be associated with a significant reduction in interictal spikes and a significant reduction in spike burden.

This study aims to determine if vigorous physical exercise results in significant increases or reductions in spike frequency in children on continuous video EEG monitoring.

The purpose of this study is to evaluate the clinical effectiveness, safety and tolerability of XEN1101 administered as adjunctive treatment in adult patients diagnosed with focal epilepsy, followed by an optional open-label extension (OLE).

The purpose of this study is to develop a prospective status epilepticus registry among twelve tertiary care pediatric hospitals in the United States focused on standardizing status epilepticus outcome assessments.

The purpose of this study is to collect preliminary data related to the clinical utility of the SPEAC System in patients with a history of motor seizures.

The primary aim of this study is to compare the pre- and post-single photon emission computed tomography (SPECT) seizure frequency following an IV benzodiazepine protocol versus reinstitution of maintenance antiseizure drugs (ASDS).

The purpose of this study is to search for necessary changes in programming or assessment structure in order to reliably capture behavioral assessments from patients during their stay in the epilepsy monitoring unit. Behavioral assessments will be collected during period of time without seizure activity, during seizure activity, and immediately after a seizure event.

The purpose of this study is to demonstrate that the RNS® system is safe and effective as an adjunctive therapy in individuals age 12 through 17 with medically refractory partial onset epilepsy.

The purpose of this study is to evaluate the course of neurodevelopmental status, adaptive status, quality of life, seizure frequency, and sleep in patients with Dravet syndrome (DS) over the timespan of two years.

The purpose of this study is to passively collect data on body movements, heart rate, breathing, and sleep physiology using radio signal analysis in subjects in their home environment to determine if analysis of the radio signal data (as recorded by the Emerald device) may be eventually used to detect/predict nocturnal seizures.

To investigate the potential antiepileptic effects of cannabidiol (GWP42003-P) in children and young adults with Dravet or Lennox-Gastaut syndromes.

The purpose of this study is to document the effectiveness of ZX008 as adjunctive therapy by documenting percent reduction in convulsive seizures and drop seizures in subjects taking ZX008compared to baseline.

The mechanisms behind how we experience the world, form memories, and make future decisions is poorly understood. We perform an observational study of rare epilepsy patients implanted with electrocorticrographic (ECoG) and stereoencephalographic (sEEG) devices in our epilepsy monitor unit to record brain signals during cognitive and memory tasks. The neural signals recorded during these computerized tasks will be invaluable for not only to discover the mysteries of our cognition, but to also advance the next generation of future diagnostic or therapeutic strategies in countless neurological diseases that affect human cognition.

The purpose of this study is to develop and validate all components of a minimally-invasive seizure detection and forecasting system.

The purpose of this study is to identify genetic causes for epilepsy (sometimes referred to as seizure disorders) and associated co-morbidities such as developmental delay (DD), intellectual disability (ID), and other neurological or neurodevelopmental disorders. We are collecting genetic and clinical information from individuals who have undergone exome/genome sequencing as part of their regular medical care or as part of a research study.

The purpose of this study is to confirm the results of a University of Pennsylvania pilot study indicating that the EvoScoreDX algorithm can differentiate patients suffering from psychogenic nonepileptic seizures (PNES) and epileptic seizures (ES) using identified proteins, demographics, and clinical data.

The purpose of this study is to demonstrate that the RNS® System for thalamic stimulation is safe and effective as an adjunctive therapy for the reduction of primary generalized seizures in individuals 12 years of age or older who have drug-resistant idiopathic generalized epilepsy.

Epilepsy is a common condition which affects over 3 million people in the US. Patients with uncontrolled epilepsy have a lifetime risk of sudden unexpected death (SUDEP) of 35%, which is greatest in those under 40 years of age. The exact mechanisms and causes are not understood but can be due to underlying conditions which affect the heart and brain, which may lead to dangerous heart rhythms and death. Some of these conditions which affect heart and brain have an identifiable genetic cause. This study aims to identify known genetic causes of heart rhythm and sudden death related disorders in ...

The purpose of this extension study is to investigate the safety of using cannabidiol in children and young adults with Dravet or Lennox-Gastaut syndromes that are not well controlled.

The purpose of the study is to evaluate the effectiveness, safety and tolerability of the 3 selected dose regimens of padsevonil (PSL) administered simultaneously with up to 3 anti-epileptic drugs (AEDs) compared with placebo for treatment of observable focal-onset seizures in adult subjects with drug-resistant epilepsy.

The seizure detection and warning system is an ambulatory system designed to monitor and analyze EMG data to detect the onset of GTC seizures and to provide a warning signal to alert caregivers that a seizure is occurring.

Clinical decision support in neurology will be using the EpiFinder tool during the assessment of patients who are being evaluated for possible epileptic seizures and syndromes.  A formal knowledge representation has been created that incorporates existing accepted classifications and peer-reviewed papers in the domain from the International League Against Epilepsy.  A heuristic algorithm has been developed that uses the knowledge representation in an algorithm that attempts to guide the assessment and provide a differential diagnosis of specific epilepsy syndromes encountered at Mayo Clinic Hospital’s Epilepsy Monitoring Unit in Arizona.  The aim is to improve the knowledge representation, term usage, assessment process, and ...

This is a multi-center, double-blind, randomized, parallel group, dose-ranging study to investigate the efficacy and clinical usability of STAP-001 in adult (18 years of age and older) subjects with epilepsy with a predictable seizure pattern. These subjects have an established diagnosis of focal or generalized epilepsy with a documented history of predictable seizure episodes. This is an in-patient study. The subjects will be admitted to a Clinical Research Unit (CRU) or Epilepsy Monitoring Unit (EMU) for study participation. The duration of the stay in the in-patient unit will be 2-8 days. One seizure event per subject will be treated with ...

The purpose of this study is to determine if adjunctive therapy of natalizumab 300 mg intravenous (IV) every 4 weeks reduces the frequency of seizures in adult participants with drug-resistant focal epilepsy. The secondary efficacy objective is to assess the effects of natalizumab versus placebo in drug-resistant focal epilepsy on additional measures of seizure frequency.

The purpose of this study is to evaluate the long-term safety and tolerability of NBI-921352 when administered for up to 106 weeks. Also, to investigate the effect of NBI-921352 on long-term seizure control.

The primary purpose of this study is to investigate the long-term safety and tolerability of TAK-935/OV935 as an adjunctive therapy in patients with epileptic seizures.

The purpose of this study is to search for reproducible changes in a wide range of physiological signals, including photoplethysmography, accelerometry, heart rate, muscle tone and activity and EEG preceding and at the onset of seizures in patients with epilepsy.

The purposes of this study are to passively collect data on body movements, heart rate, breathing, and sleep physiology using radio signal analysis in subjects who are being monitored in the Mayo Clinic Epilepsy Monitoring Unit for clinical purposes, and to determine if analysis of the radio signal data (as recorded by the Emerald device) may be eventually used to detect/predict nocturnal seizures.

The purpose of this study is to assess how accurately a portable single-channel EEG device (Epilog™ by Epitel) detects generalized non-convulsive seizures, and to determine the feasibility of use of this device in an acute setting such as the Emergency Department (ED).

The purpose of this post-approval study is to further evaluate the long-term safety and effectiveness of Medtronic DBS therapy for epilepsy on seizure reduction in newly implanted participants through 3 years of follow-up in different geographic populations.

The purpose of this study is to assess the thalamus area of the brain using stereotactic electroencephalography (an EEG with deep electrode placement inside the brain) to better understand its role in the starting and spreading of epileptic seizure activity.

The purpose of this study is to provide patients with Dravet Syndrome, who do not qualify for participation in one of the ongoing ZX008 clinical trials, to receive treatment.

The purpose of this study is to assess the long-term safety and tolerability of CVL-865 as adjunctive therapy in participants with focal onset seizures.

The primary purpose of this study is to evaluate the safety and tolerability of cenobamate in pediatric subjects 2 to ≤ 18 years of age with partial-onset (focal) seizures.

The seconday objectives of this study are to evaluate the efficacy of cenobamate tablets and suspension in pediatric subjects with partial onset (focal) seizures, to collect plasma samples of cenobamate to support the evaluation of the pharmacokinetics of cenobamate tablets and suspension in pediatric subjects with partial onset (focal) seizures, to collect plasma samples of cenobamate to support the evaluation of the PK/pharmacodynamics of cenobamate in pediatric subjects with partial onset (focal) seizures, and the acceptability and palatability assessment (determined by a ...

The purpose of this study is to investigate the effectiveness and safety of the potential anti-seizure effects of cannabidiol (GWP42003-P) in children and adults with Lennox-Gastaut syndrome.

The primary objective of this study is to create common data elements collected at all centers participating in this collaborative allowing for direct data comparison amongst participating centers. Secondary objectives will compare how Pediatric Epilepsy Centers evaluate surgery candidates in order to inform future studies to compare and potentially standardize the process.

The purpose of this study is to identify clinical characteristics and biomarkers predictive of disease outcome, progression, and treatment response in participants with treatment-resistant focal epilepsy.

The purpose of this study is to evaluate the effectiveness of Lacosamide (LCM) vs. an Active Comparator chosen based on Standard-of-Care (StOC) in severe and nonsevere seizure burden (defined as total minutes of electroencephalographic neonatal seizures (ENS) per hour) in neonates with seizures that are not adequately controlled with previous anti-epileptic drug (AED) treatment.

The purpose of this study is to evaluate the custom made Stealth Arc Delivery device versus a commercially available device to improve the precision, efficiency and workflow of implanting Stereo electroencephalography (sEEG) electrodes into patients who have medically unmanageable epilepsy. Successful sEEG monitoring can identify areas of the brain where epileptic seizures originate for later surgical removal.

This study will assess long-term safety and tolerability of repeat dose diazepam nasal spray in adolescents and adults with cluster seizures, with a focus on potential local effects (changes in nasal mucosa, olfaction, and taste).

The purpose of this study is to gather additional information on the long-term safety, tolerability, and impact on seizure frequency and duration of repeated doses of STK-001 administered every 4 months by intrathecal (IT) injection.

The purpose if this study  to combine state of the art cerebral signal processing techniques and localization methods with intracranial electrode recordings to investigate the interaction of local hippocampal and neocortical networks with distributed brain activity.

The purpose of this study is to determine the rate of motor vehicle collisions (MVCs) due to spells in patients diagnosed with psychogenic, non-epilepic seizures (PNES) and compare to those diagnosed with epilepsy and to the general population.

The purpose of this study is to document the effectiveness of  ZX008 as adjunctive therapy by documenting percent reduction in convulsive seizures and drop seizures in subjects taking ZX008 compared with baseline.

The purpose of the study is to evaluate the long-term safety and tolerability of Staccato alprazolam.

This trial consists of 2 parts: a double-blinded phase and an open-label extension phase. The blinded phase only will be described in this record. Participants will receive 1 of 2 doses of GWP42003-P or matching placebo. The primary clinical hypothesis is that there will be a difference between GWP42003-P and placebo in their effect on seizure frequency.

The purpose of this study is to determine the changes to visual fields and to neuropsychological assessments after laser ablation procedures  for temporal lobe epilepsy.

The purpose of this study is to evaluate the long-term safety of ZX008 in subjects with Dravet syndrome, Lennox-Gastaut syndrome or epileptic encephalopathy.

The purpose of this trial is to assess the safety and effectiveness of Ganaxolone (GNX) compared to placebo as adjunctive therapy for seizures associated with Tuberous Sclerosis Complex (TSC) in children and adults as assessed by the change from baselinea in the frequency of countable major motor and focal seizures (primary endpoint seizuresb) during the double-blind phase.

The purpose of the study is to assess the success of a single administration of Staccato alprazolam compared with placebo both in rapidly terminating a seizure episode within 90 seconds and with no recurrence of seizure(s) up to 2 hours after investigational medicinal product (IMP) administration.

The primary objective of this study is to investigate the safety, tolerability, and effectiveness of multiple doses of LP352 in adult subjects with developmental and epileptic encephalopathies.

This study is designed to use new MRI techniques to better understand and treat seizure disorders

The purpose of this study is to evaluate the initial safety and effectiveness of Microburst VNS stimulation in subjects with refractory epilepsy.

The purpose of this study is to evaluate the effectiveness of Perampanel on seizure frequency in adult patients with brain-tumor with and without seizures associated with glioma.

The purpose of this study is to establish a patient and clinical information database, and a genetic material biobank to better characterize the symptoms and unknown genetic causes of Angelman syndrome

The purpose of this study is to investigate if blood and/or MRI markers of inflammation and immune system activation may show changes in relation to when you have a seizure, and to noninvasively detect seizure related structural and functional alterations in acute seizure by MRI.

The purpose of this study is to connect brain inflammation measured by biomarkers, with data from advanced EEG technology, and clinical outcomes to provide new predictive information about seizure activity in children with critical brain injuries and epilepsy.

The investigators believe epilepsy alters the way the body controls blood pressure, heart rate and breathing, and these changes increase the risk of sudden unexpected death in patients with epilepsy (SUDEP). SUDEP-7 is a risk scoring tool which may correlate with these changes to the heart and blood vessels. This research study measures those differences which may help identify new markers to help predict those patients at greatest risk in the future.

The objectives of this study are to assess the effectiveness of NBI-921352 as adjunctive therapy on the frequency of countable motor seizures (defined as generalized tonic-clonic seizure [GTCS], tonic, atonic or focal onset   seizures [FOS] with noticeable motor component), to evaluate the effectiveness of NBI-921352 using the Clinical and Parent/Caregiver Global Impression of Change scales and the Clinical and Parent/Caregiver Global Impression of Severity scales, to explore the effect of NBI-921352 on symptoms and seizure activity, physical activity, quality of life, as well as seizure freedom. to characterize the pharmacokinetics (PK) of NBI-921352 and determine the effect of NBI-921352 on plasma levels of concomitant antiseizure ...

The purpose of this study is to identify clinical characteristics and biomarkers predictive of disease outcome, progression, and treatment response in participants with idiopathic generalized epilepsy (IGE).

The purpose of the study is to assess the efficacy of rozanolixizumab as measured by seizure freedom, change in cognitive function, use of rescue medication, onset of seizure freedom and to assess safety and tolerability.

The purpose of this study is to develop and test the effectiveness of an investigational imaging technique called magnetic resonance elastography (MRE) to measure the stiffness (mechanical properties) of tissues.

The purpose of the study is:

1. To determine the incidence of subclinical electrographic seizures and electrographic status epilepticus in children admitted to the PICU for head trauma, traumatic brain injury (TBI), and/or child abuse at National Children’s Hospital in Hanoi, Vietnam.

2. To determine whether a correlation exists between length of stay, morbidity, and mortality with incidence of subclinical SE and seizures.

The purpose of this study is to characterize and study the relationship of the clinical risk factors and predictors of seizures and epilepsy in patients with Early Onset Alzheimer's Disease (EOAD) using a 48-hour CAA-EEG.