Clinical Trials for Epilepsy

Source: ClinicalTrials.gov — U.S. National Library of Medicine — A database of privately and publicly funded clinical studies conducted around the world (U.S. National Library of Medicine, public domain).

This page lists clinical trials related to Epilepsy from the ClinicalTrials.gov database.

Trial Summary

• Total studies: 50
• Recruiting: 25
• Active, not recruiting: 8
• Completed: 7
• Other: 10

Results are refreshed periodically and may not reflect the most current information available from ClinicalTrials.gov.

Recruiting Trials

NCT01273129 — Surgery as a Treatment for Medically Intractable Epilepsy

Background:

- Drug resistant epilepsy is the term used to describe epilepsy that cannot be controlled by medication. Many people whose seizures do not respond to medication will respond to surgical treatment, relieving seizures completely or almost completely in one-half to two-thirds of patients who qualify for surgery. The tests and surgery performed as part of this treatment are not experi…

NCT02107989 — Noninvasive Pre-surgical Evaluation of Patients With Focal Epilepsy and Establishment of a Normative Imaging Database

Objectives:

The overall study objective is to compare the sensitivities and specificities of morphometric analysis techniques using structural MRI images based on pre- and postsurgical localization of epileptic foci in patients undergoing presurgical evaluation for medically refractory epilepsy. To carry out these analyses, we aim to establish an age-stratified normative imaging database using…

NCT04462770 — A Study of EPX-100 (Clemizole Hydrochloride) in Participants With Dravet Syndrome

This is a multicenter, Phase 3, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of clemizole hydrochloride (EPX-100) as adjunctive therapy in children and adult participants with Dravet syndrome (DS).

NCT05283811 — Understanding Prefrontal and Medial Temporal Neuronal Responses to Algorithmic Cognitive Variables in Epilepsy Patients

Humans have a remarkable ability to flexibly interact with the environment. A compelling demonstration of this cognitive flexibility is human’s ability to respond correctly to novel contextual situations on the first attempt, without prior rehearsal. The investigators refer to this ability as ‘ad hoc self-programming’: ‘ad hoc’ because these new behavioral repertoires are cobbled together on th…

NCT05667142 — A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety, and tolerability of XEN1101 administered as adjunctive treatment in primary generalized tonic-clonic seizures (PGTCS).

NCT05854160 — Stimulation-Induced Changes in Fronto-Limbic Network

The purpose of this research is to better understand how emotion processing unfolds in the brain using stereoelectroencephalography (sEEG) and direct brain stimulation. This study will use standard behavioral emotion processing tasks combined with neural recording and direct brain stimulation to assess different aspects of emotion processing. Stimulation pulses during pre and post-test periods …

NCT06975800 — Effects of Social Feedback on Intracranial EEG

This study aims to assess the impact of social influence on direct neural recordings in human patients undergoing surgical treatment of epilepsy. 24 patients recruited from the Epilepsy Center at Dartmouth Health Medical Center (DHMC) will undergo electrode implantation throughout the brain to localize epileptogenic zones. Patients will be asked to rate their provider’s warmth, competence, and …

NCT05864547 — Predisposing Factors for Post-stroke Epilepsy

The goal of this observational study is to learn about epilepsy after a stroke (post-stroke epilepsy). The main questions it aims to answer are:

• What make some patients develop epilepsy after a stroke?
• Does sleep have an impact on the development of post-stroke epilepsy?

Participants will undergo:

• Electroencephalography (EEG)
• Magnetic resonance imaging (MRI)
• Polysomnography (only p…

NCT06019182 — MEHMO Natural History and Biomarkers

This observational natural history study will follow individuals with MEHMO (Mental disability, Epileptic seizure, Hypopituitarism/Hypogenitalism, Microcephaly, Obesity) syndrome or an eIF2-pathway related disorder, who have symptoms such as intellectual delay, seizures, abnormal hormone and blood sugar levels, and decreased motor skills.

No current treatment for these conditions is available….

NCT05419492 — A Clinical Study to Evaluate the Safety and Efficacy of ETX101 in Infants and Children With SCN1A-Positive Dravet Syndrome

ENDEAVOR is a Phase 1/2, 2-part, multicenter study to evaluate the safety and efficacy of ETX101 in participants with SCN1A-positive Dravet syndrome aged ≥6 to <36 months (Part 1A), aged ≥48 months to <18 years (Part 1B), and aged ≥6 to <48 months (Part 2). Part 1A follows an open-label, dose-escalation design, Part 1B follows an open-label design, and Part 2 is a randomized, double-blind, s…

NCT06608966 — Epilepsy Journey-An Executive Functioning Intervention for Teens With Epilepsy

The goal of this multi-site clinical trial is to determine the effectiveness of two components of a web-based intervention (Epilepsy Journey) to improve executive functioning in adolescents with epilepsy. The two components include web-based modules and problem-solving telehealth sessions with a therapist focused on executive functioning. This trial aims to answer the following questions:

1. W…

NCT06661759 — Clinic-based and Technology-Supported Sleep Intervention for Pediatric Epilepsy

Sleep problems are more common and more severe in children with epilepsy. The purpose of this study is to develop and evaluate the effect of a clinic-based and technology-supported sleep intervention for improving sleep and health in children with epilepsy and their parents.

NCT02531880 — Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy

Background:

- The blood-brain barrier separates the brain from the rest of the body. Epilepsy is a neurological disease that causes seizures. It can affect this barrier. Researchers think a contrast agent called mangafodipir might be better able to show areas of the brain that epilepsy affects.

Objective:

- To see if mangafodipir is well tolerated and safe. To see if magnetic resonance ima…

NCT07668856 — Cannabidiol as add-on Therapy for Children With Refractory Epilepsy (CBD-uN1que), a High-quality Individualized Approach: a Series of N-of-1 Trials

The goal of this clinical trial is to learn if cannabidiol (“CBD-oil”) works to treat severe epilepsy in children. It will also learn about the safety of cannabidiol. The main questions it aims to answer are:

• Does cannabidiol lower the number of seizure in children with severe epilepsy?
• Does cannabidiol effect other outcomes such as behaviour, sleep, communication, activities?
• What medic…

NCT05066217 — An Efficacy and Safety Study of Clemizole HCl in Patients With Lennox-Gastaut Syndrome

This is a multicenter, Phase 3, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of clemizole HCL (EPX-100) as adjunctive therapy in children and adult participants with Lennox-Gastaut syndrome (LGS).

NCT06872125 — A Double-blind Study Evaluating the Efficacy, Safety, and Tolerability of Zorevunersen in Patients With Dravet Syndrome

The purpose of the study is to evaluate the efficacy, safety, and tolerability of zorevunersen in Patients with Dravet syndrome.

NCT07680842 — Non-Invasive Low Intensity Focused Ultrasound Stimulation for Drug-Resistant Epilepsy

The goal of this study is to investigate the effects of a non-invasive, low intensity focused ultrasound (LIFU) stimulation on seizure frequency and the epileptogenic network in drug-resistant epilepsy. LIFU uses focused sound waves to modulate deep brain regions and to enable changes in brain network activity. Encephalography (EEG) and behavioral tasks will also be used to study how LIFU affec…

NCT06700811 — Ketogenic Diet for Prevention of Epileptic Spasms in Infantile Onset Genetic Epilepsies

Epileptic spasms (ES) are a predominantly infantile seizure type observed frequently in certain genetic disorders. Ketogenic diet (high ratio of fat to carbohydrate/protein) is an established non-medication treatment for difficult to control seizures, including ES. Because ES are associated with worse developmental and cognitive outcomes if not detected or treated quickly and effectively, this …

NCT06455384 — The Genetics Navigator: Evaluating a Digital Platform for Genomics Health Services

Genetic testing (GT) (including targeted panels, exome and genome sequencing) is increasingly being used for patient care as it improves diagnosis and health outcomes. In spite of these benefits, genetic testing is a complex and costly health service. This results in unequal access, increased wait times and inconsistencies in care. The use of e-health tools to support genetic testing delivery c…

NCT07675746 — A Study to Evaluate the Safety and Pharmacokinetics of RC001 in Children With Dravet Syndrome

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.

NCT07224191 — Hippocampal Oscillations During Exploration

The objective of this study is to determine how visuomotor exploration relates to hippocampal activity along its long axis. The study will investigate the neurophysiological mechanisms in the hippocampus during (1) visual exploration in surgical patients using high-resolution iEEG, and (2) ambulatory exploration in patients implanted with RNS devices.

NCT07594119 — Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures

This is a clinical research study for an investigational drug called RAP-219 in adult participants with focal seizures. This study is being conducted to determine if RAP-219 is safe and effective in reducing focal seizure frequency.

NCT07399327 — Biomarkers of Response to SEEG Thermocoagulation

Drug-resistant focal epilepsy is a severe neurological disease that affects one-third of patients with epilepsy. Surgery is the only potentially curative treatment. Intracerebral exploration by stereo electroencephalography (SEEG) is an important step in the surgical pathway. It aims to establish the precise mapping of the epileptogenic network (EZN), including all the brain regions that genera…

NCT07656857 — High-density Flexible μECoG for Epilepsy Surgery - A Single-Arm ECT

What’s the clinical value of high-density flexible microelectrocorticography (μECoG) for guiding the resection of epileptogenic zone (EZ) in epilepsy surgery?

NCT07102524 — Intrathecal Gene Therapy For SLC13A5 Citrate Transporter Disorder

Phase 1/2, open-label study to assess the efficacy and safety of a single lumbar intrathecal administration of TSHA-105 in individuals with SLC13A5 Citrate Transporter Disorder

Active, Not Recruiting

NCT03655223 — Early Check: Expanded Screening in Newborns

Early Check provides voluntary screening of newborns for a selected panel of conditions. The study has three main objectives: 1) develop and implement an approach to identify affected infants, 2) address the impact on infants and families who screen positive, and 3) evaluate the Early Check program. The Early Check screening will lead to earlier identification of newborns with rare health condi…

NCT04015141 — A Study to Evaluate Efficacy and Safety of Perampanel Administered as an Adjunctive Therapy in Pediatric Participants With Childhood Epilepsy

The purpose of the study is to evaluate the efficacy of perampanel as measured by the 50 percent (%) responder rate during the maintenance period of the core study for seizure frequency in participants with pediatric epileptic syndrome (Cohort 1) and partial-onset seizures (POS) (Cohort 2).

NCT05044819 — Assessment of Potential for Chronic Liver Injury in Participants Treated With Epidiolex (Cannabidiol) Oral Solution

This study will monitor for potential chronic liver injury and liver fibrosis, in participants treated with cannabidiol oral solution.

NCT05283200 — Creating a Healthy L.I.F.E: Lifestyle Interventions For Epilepsy

A prospective controlled, randomized study to examine the effects of behavioral and wellness-based interventions on seizure frequency for adult patients with medication resistant epilepsy who are still experiencing 1 or more seizures per month.

NCT06143293 — RESEARCH EVALUATING VAGAL EXCITATION AND ANATOMICAL LINKS

The acute and chronic effects of VNS stimulation on various on the autonomic nervous, cardiovascular, immune, and metabolic systems will be compared from noninvasive and minimally invasive physiological recordings and blood draws at various time points throughout the study. These interventions and assessments will be performed in individuals 18 years of age and older who are implanted with a VN…

NCT06346262 — Seizure Rescue Medication (RM) as Part of a Comprehensive Epilepsy Self-management Package of Care

This study will be done in two phases. Using stakeholder input (community advisory board (CAB)), the study team will adapt the SMART program to incorporate education and self-management support for use of Rescue Medication (RM) to manage seizure occurrence among Persons With Epilepsy (PWE) who have repetitive seizures. Additional content/support materials, pending input stakeholder might includ…

NCT06309966 — Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy

The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.

NCT07676539 — Adapting the STRW Intervention for Adolescents and Young Adults With Epilepsy (ARGOS)

The goal of this clinical trial is to learn if a telehealth intervention (Surviving and Thriving in the Real World; STRW) is helpful to improve daily living skills for teens and young adults with epilepsy. It will also learn about the acceptability, feasibility, and satisfaction of the intervention. The main questions it aims to answer are:

• Is STRW an acceptable, feasible, and satisfactory i…

Not Yet Recruiting

NCT07520955 — Lily’s Grace Temporal Interference

This study is to evaluate the effectiveness of targeted Transcranial Electrical Stimulation with Temporal Interference (TES-TI) interventions to boost Non-Rapid Eye Movement (NREM) sleep, decrease seizures and promote emotional health in patients with epilepsy. Up to 24 participants (8 control participants for technical optimization prior to recruitment and 16 patients with epilepsy) will be en…

NCT07531511 — SLC6A1-NDD Prospective Longitudinal Natural History Study

The overall objective of this prospective longitudinal natural history study is to collect clinical data to characterize and evaluate the natural course of SLC6A1-NDD and assess the feasibility of certain assessments for the purpose of conducting future clinical studies in patients with this disease.

NCT07680322 — A Phase 2 Study of the Safety and Efficacy of AV078 in Participants With Tuberous Sclerosis Complex (TSC) Refractory Epilepsy

This Phase 2, randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability, and efficacy of oral AV078 in participants with refractory epilepsy due to tuberous sclerosis complex (TSC). Approximately 42 participants will be randomized in a 5:1 ratio to receive AV078 or placebo.

The study will include a Screening Period collecting 4 weeks of pre-treatment Baseline da…

NCT07458217 — Combined CM and STN Stimulation for Motor Epilepsy

This self-crossover, randomized controlled, pilot study aims to collect clinical data of bilateral stimulation of subthalamic nucleus (STN) combined with centromedian (CM) thalamus deep brain stimulation (DBS) for drug resistant epilepsy with motor symptom in adults.

Enrolling by Invitation

NCT05152992 — Spatiotemporal Dynamics of the Human Emotion Network

The overall goal of this study is to elucidate how emotion network dynamics relate to the behavioral, autonomic, and experiential changes that accompany emotions and to investigate how emotion network dysfunction relates to affective symptoms. Affective symptoms are a common feature of neuropsychiatric disorders that reflect dysfunction in a distributed brain network that supports emotion. How …

NCT05435859 — Functional Organization of the Superior Temporal Gyrus for Speech Perception

The basic mechanisms underlying comprehension of spoken language are still largely unknown. Over the past decade, the study team has gained new insights to how the human brain extracts the most fundamental linguistic elements (consonants and vowels) from a complex and highly variable acoustic signal. However, the next set of questions await pertaining to the sequencing of those auditory element…

NCT05718817 — An Open-label Study of XEN1101 in Epilepsy

This study will evaluate the long term safety, tolerability, pharmacokinetics (PK), and efficacy of XEN1101 in subjects with Focal Onset Seizures (FOS) or Primary Generalized Tonic-Clonic Seizures (PGTCS) for the treatment of seizures for up to 6 years.

NCT07663240 — Epilepsy Emergency Department High Utilizer Program

We believe that there are many reasons that people with epilepsy get their health care through the emergency department (ED) instead of through primary care or neurology. Our goal is to create program that will address these reasons. The creation of this program will be informed by use of the Grady electronic health records (EHR). We will use the EHR to describe people with epilepsy coming the …

Completed Trials

NCT03678753 — Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Cenobamate Adjunctive Therapy in PGTC Seizures

This trial is intended to study the safety and effectiveness of an new anti-epileptic drug (AED) on Primary Generalized Tonic-Clonic (PGTC) Seizures. Eligible Subjects, adults and adolescents, will continue to take their usual AEDs and receive either cenobamate or placebo. Subjects will have a 50% chance or receiving cenobamate or placebo (sugar pill). Subjects will initially receive 12.5 mg of…

NCT03961568 — Cenobamate Open-Label Extension Study for YKP3089C025

52 Week Open-Label Safety Study of Cenobamate for Subjects who Complete YKP3089C025 (core study)

NCT04117425 — Pharmacokinetic and Placental Transfer of Levetiracetam

Hypotheses: The treatment of epilepsy during pregnancy is difficult because of the risk of anti-epileptic drugs on the one hand and the risk of destabilization of epilepsy in the mother on the other hand. There is limited data on the pharmacokinetics (concentration study) and pharmacodynamics (efficacy and toxicity effects study) of levetiracetam in pregnant women. The few studies focus on few …

NCT07689617 — Ultrasound-Guided Intermediate Cervical Plexus Block for Postoperative Analgesia in Vagus Nerve Stimulation Surgery

This prospective, randomized, double-blind, placebo-controlled clinical trial aims to evaluate the analgesic efficacy of ultrasound-guided intermediate cervical plexus block (ICB) in patients undergoing vagus nerve stimulation (VNS) implantation surgery under general anesthesia. Participants are randomly assigned to receive either an ultrasound-guided ICB with 10 mL of 0.25% bupivacaine or a pl…

NCT07667075 — Role-Playing Method in Epilepsy Teaching Among Nursing Students

This study aims to evaluate the effects of a role-playing method in epilepsy teaching on nurse-patient communication skills, self-efficacy, and knowledge among undergraduate nursing students in Hainan Province, China. Participants will be undergraduate nursing students who meet the eligibility criteria. They will be assigned to either an intervention group or a control group. The intervention g…

NCT07684352 — Slow Oscillatory Transcranial Direct Current Stimulation for Refractory Focal Epilepsy

This pilot study evaluated whether a type of non-invasive brain stimulation called slow-oscillatory transcranial direct current stimulation (so-tDCS) can reduce seizure frequency in patients with drug-resistant focal epilepsy. Ten patients received 14 days of so-tDCS (2 mA, 1 Hz) for 20 minutes twice daily, guided by their individual seizure focus identified by EEG and MRI. Seizure frequency an…

NCT07689084 — Training Program to Improve EEG Competence

The goal of this clinical trial is to investigate the extent to which a practice-oriented training program for intensive care nursing staff and non-physician treatment teams can contribute to the earlier detection of epileptic seizures, with particular emphasis on SE.

Further objectives include enhancing competence in EEG interpretation and minimizing existing communication and procedural barr…

Available Studies

NCT03778424 — An Extended Access Program (EAP) for Participants Who Have Completed Rufinamide Study E2080-G000-303

This is an extended access study for participants who have completed Rufinamide Study E2080-G000-303 to continue to have access to rufinamide until it becomes commercially available in Poland or until no participants remain in the EAP.

Other (Withdrawn)

NCT04569708 — Sleep Spindles and Memory in Rolandic Epilepsy

The investigators are recruiting children with Rolandic epilepsy and children without epilepsy (aged 4 years old and above) for a non-invasive brain imaging study using Magnetic Resonance Imaging (MRI), Magnetoencephalography/Electroencephalography (MEG/EEG), and experimental tasks. The investigators hope to determine the brain circuits and brain rhythms affected in these children and ultimatel…