Clinical trials: Drug-Resistant Epilepsy
Perinatal Stroke, Epilepsy
Long-Term Epilepsy Outcomes in Children With a History of Perinatal Stroke
Perinatal stroke is a rare condition affecting approximately 20-40 births per 100,000. It may be ischemic or hemorrhagic and can occur before or around birth, with diagnosis sometimes delayed until motor or cognitive symptoms…
- Conditions
- Perinatal Stroke, Epilepsy, Post-Stroke Epilepsy
- Trial name
- EPI-STROKE (NCT07898397)
- Where
- France
- Volunteers
- 120 people
- Sponsor
- University Hospital, Strasbourg, France
Tuberous Sclerosis Complex
Placebo Controlled Study to Assess the Efficacy and Safety of Rapamycin in Drug Resistant Epilepsy Associated With Tuberous Sclerosis Complex
The purpose of the RaRE-TS study is to determine safety, tolerability and efficacy of rapamycin versus placebo in a drug resistant epilepsy associated with tuberous sclerosis complex (TSC).
- Trial name
- RaRE-TS (NCT05534672)
- Testing
- Rapamycin
- Where
- 2 sites in Poland
- Volunteers
- 200 people
- Sponsor
- Katarzyna Kotulska
Epilepsy Intractable
Add-on Clioquinol in Drug-resistant Childhood Epilepsy: an Exploratory Study
In this exploratory trial, the potential anti-seizure activity of clioquinol in a small cohort of adolescents with drug-resistant epilepsy will be examined.
- Trial name
- CLIOKID (NCT05727943)
- Testing
- Clioquinol
- Where
- Belgium
- Volunteers
- 10 people
- Sponsor
- KU Leuven
Epilepsies, Myoclonic, Drug Resistant Epilepsy
Extended Access Program With Lorcaserin For The Treatment of Dravet Syndrome and Other Refractory Epilepsies
The primary purpose of this study is to provide continued access of lorcaserin to participants with Dravet syndrome and other refractory epilepsies.
- Trial name
- NCT04457687
- Testing
- Lorcaserin
- Where
- 22 sites in United States, Canada
- Sponsor
- Eisai Inc.
Drug Resistant Epilepsy, Refractory Epilepsy
Post-Market Real-World Evidence Registry for the NeuroOne OneRF® Ablation System for Epilepsy
This is a multi-site registry study that aims to collect real-world clinical outcomes and device performance of the OneRF Ablation System.
- Trial name
- NCT07546253
- Testing
- Participants are not assigned an intervention as part of the study.
- Where
- 3 sites in United States
- Volunteers
- 100 people
- Sponsor
- NeuroOne Medical Technologies Corporation
Developmental and Epileptic Encephalopathies, Epileptic Spasms
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…
- Conditions
- Developmental and Epileptic Encephalopathies, Epileptic Spasms, Genetic Epilepsy, Neonatal and Infant Epilepsy
- Trial name
- NCT06700811
- Testing
- Ketogenic diet
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Heather Olson
Epilepsy, Rare Diseases
Cannabidiol in Children and Young Adults With Rare Disease-associated Severe Epilepsy
This is a pilot, open-label, phase II study. The main objective of the study is to demonstrate that Cannabidiol (CBD), used in addition to current anti-seizure medications (ASMs) reduces the number and/or severity of motor…
- Trial name
- CBD_RE (NCT05803434)
- Testing
- Cannabidiol oral solution
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- Meyer Children's Hospital IRCCS
CDKL5 Deficiency Disorder
Efficacy and Safety Evaluation of Hyperthermic Baths in the Treatment of Seizures in CDKL5 Deficiency Disorder
The primary objective of this research is to study the efficacy and safety of hyperthermic baths as adjunctive therapy for reducing the frequency of seizures in CDKL5 deficiency.
- Trial name
- NCT06447675
- Testing
- Hyperthermic Baths
- Where
- China
- Volunteers
- 8 people
- Sponsor
- Xuanwu Hospital, Beijing
Epilepsy Intractable
Pediatric Epilepsy
The purpose of the research is to better understand how the human brain accomplishes the basic cognitive tasks of learning new information, recalling stored information, making decisions or choices about presented information and…
- Trial name
- NCT07350551
- Testing
- Cedrus RB series response pad; Adtech Behnke-Fried micro-electrodes; Neuralynx or Blackrock electrophysiology system; Blackrock Cerestim or Natus Nicolet stimulator
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- University of Texas Southwestern Medical Center
Epilepsy
ESIS in Pediatric DRE
The main reason for this research study is to gain information about how the brain makes seizures by causing seizures using very small amounts of current, or electrical stimulation.
- Trial name
- NCT05469373
- Where
- United States
- Volunteers
- 86 people
- Sponsor
- Sarah Katie Ihnen
Refractory Epilepsy, SYNGAP1 Encephalopathy
Fenfluramine for the Treatment of Different Types of Developmental and Epileptic Encephalopathies: a Pilot Trial Exploring Epileptic and Non-epileptic Outcomes
This study is a pilot non-controlled clinical trial with adjunctive fenfluramine for the treatment of five different types of developmental and epileptic encephalopathies (DEEs) focused on epileptic and "non-epileptic outcomes"…
- Conditions
- Refractory Epilepsy, SYNGAP1 Encephalopathy, STXBP1 Encephalopathy With Epilepsy, Inv Dup(15) Encephalopathy
- Trial name
- FENDEEP (NCT05232630)
- Testing
- Fenfluramine
- Where
- Spain
- Volunteers
- 20 people
- Sponsor
- Hospital Ruber Internacional
Tuberous Sclerosis Complex, Epilepsy
Safety and Efficacy of AV078 in Participants With Tuberous Sclerosis Complex (TSC) Refractory Epilepsy (RESTOR-1)
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).
- Trial name
- RESTOR-1 (NCT07680322)
- Testing
- AV078
- Where
- Canada
- Volunteers
- 42 people
- Sponsor
- Aeovian Pharmaceuticals, Inc.
Other Forms of Epilepsy, Treatment Resistant
TDCs to Treat Drug-resistant Epilepsy
Epilepsy is the fourth overall neurologic disorder, regardless of age and gender, affecting more than 50 million people worldwide.
- Trial name
- NCT05825274
- Testing
- Active Cathodal tDCS
- Where
- United Kingdom
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Spanish Foundation for Neurometrics Development
Drug Resistant Epilepsy
Feasibility Study of the iVEAcare Neuromodulation System for the Treatment of Drug-Resistant Epilepsy
The purpose of this study is to assess the safety and performance of the iVEAcare Neuromodulation System for the treatment of drug-resistant epilepsy.
- Trial name
- iVEAcare-FS (NCT07640191)
- Testing
- iVEAcare Neuromodulation System
- Where
- 7 sites in Australia
- Volunteers
- 30 people
- Sponsor
- iVEAcare
Epilepsy Intractable
Neuronal Mechanisms of Human Episodic Memory
The purpose the research is to better understand how the human brain accomplishes the basic cognitive tasks of learning new information, recalling stored information, and making decisions or choices about presented information.
- Trial name
- NCT04500119
- Testing
- Cedrus RB-844 response pad; Adtech Behnke-Fried micro-electrodes; Neurolynx electrophysiology system; Blackrock Cerestim stimulator
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Cedars-Sinai Medical Center
Focal Epilepsy, Drug-resistant Focal Epilepsy
RNS System for Drug-Resistant Focal Epilepsy in Adolescents: A Real-World Study
The NeuroPace RNS System is FDA-approved for adults with drug-resistant focal epilepsy but is not yet approved for adolescents. This study uses real-world data to evaluate the RNS System's safety and effectiveness in adolescents…
- Trial name
- AURORA (NCT07823465)
- Testing
- NeuroPace RNS System
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- NeuroPace
Epilepsy Intractable
Sleep Disruption Pattern - Epilepsy Monitoring Unit
Epilepsy affects millions worldwide, with 40% of patients experiencing uncontrolled seizures despite medication. Comprehensive epilepsy centers recommend continuous video-electroencephalography monitoring to define seizure type…
- Trial name
- NCT06581133
- Testing
- Alarm system
- Volunteers
- 75 people
- Sponsor
- Duke University
Refractory Epilepsy
Optimal Stimulation Parameters to Disrupt Epileptiform Activity
Open-loop electrical stimulation has been found to reduce spike activity and seizures, but determining the optimal parameters to achieve these effects requires a brute force trial-and-error approach that relies on subjective…
- Trial name
- NCT06141668
- Testing
- Neurostimulation
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Massachusetts General Hospital
Drug-Resistant Epilepsy, ARX-Related Epilepsy
Occupational Therapy Approach in ARX-Related Epilepsy
This study evaluated the effects of medical ketogenic diet therapy combined with occupational therapy in children with ARX-related epilepsy. Twenty children were included.
- Trial name
- NCT07745608
- Testing
- Occupational Therapy, Medikal Ketogenic Diet Therapy
- Where
- Turkey (Türkiye)
- Volunteers
- 20 people
- Sponsor
- Uskudar University
Epilepsy Intractable
A Multifaceted Assessment of Eating Behaviors, Anthropometric Measurements and Body Composition in Pediatric Patients With Drug-resistant Epilepsy on a Ketogenic Diet and Healthy Children
The goal of this observational study is to compare the prevalence and severity of eating behaviors-such as food neophobia, picky eating, food fussiness, meal repetition and variety, and food texture preferences-between healthy…
- Trial name
- NCT07714226
- Where
- 2 sites in Poland
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Wroclaw Medical University