Seizures clinical trials at UCSF
12 in progress, 7 open to eligible people
Seizures are sudden, uncontrolled movements of the body caused by abnormal electrical activity in the brain. At UCSF, there are several clinical trials recruiting patients with different types of seizures. Some trials are testing new medications, like "EPX-100" and "XEN496," while others are studying the long-term safety of existing medications. Additionally, there are studies that aim to better understand the causes of seizures and identify new ways to effectively treat them, such as the "Neonatal Seizure Registry" and the "RNS System LGS Feasibility Study."
An Open-Label Extension of the Study XEN496 (Ezogabine) in Children With KCNQ2-DEE
open to eligible people ages 1 month to 6 years
To assess the long-term safety and tolerability of XEN496 in pediatric subjects with KCNQ2 developmental and epileptic encephalopathy (KCNQ2-DEE) who had participated in the primary study (XPF-009-301).
San Francisco, California and other locations
EPX-100 (Clemizole Hydrochloride) as Add-on Therapy to Control Convulsive Seizures in Patients With Dravet Syndrome
open to eligible people ages 2 years and up
The purpose of this study is to evaluate the safety and efficacy of EPX-100 as adjunctive therapy in children and adult participants with Dravet Syndrome.
San Francisco, California and other locations
Pediatric Dose Optimization for Seizures in Emergency Medical Services
open to eligible people ages 6 months to 13 years
The Pediatric Dose Optimization for Seizures in Emergency Medical Services (PediDOSE) study is designed to improve how paramedics treat seizures in children on ambulances. Seizures are one of the most common reasons why people call an ambulance for a child, and paramedics typically administer midazolam to stop the seizure. One-third of children with active seizures on ambulances arrive at emergency departments still seizing. Prior research suggests that seizures on ambulances continue due to under-dosing and delayed delivery of medication. Under-dosing happens when calculation errors occur, and delayed medication delivery occurs due to the time required for dose calculation and placement of an intravenous line to give the medication. Seizures stop quickly when standardized medication doses are given as a muscular injection or a nasal spray. This research has primarily been done in adults, and evidence is needed to determine if this is effective and safe in children. PediDOSE optimizes how paramedics choose the midazolam dose by eliminating calculations and making the dose age-based. This study involves changing the seizure treatment protocols for ambulance services in 20 different cities, in a staggered and randomly-assigned manner. One aim of PediDOSE is to determine if using age to select one of four standardized doses of midazolam and giving it as a muscular injection or nasal spray is more effective than the current calculation-based method, as measured by the number of children arriving at emergency departments still seizing. The investigators believe that a standardized seizure protocol with age-based doses is more effective than current practice. Another aim of PediDOSE is to determine if a standardized seizure protocol with age-based doses is just as safe as current practice, since either ongoing seizures or receiving too much midazolam can interfere with breathing. The investigators believe that a standardized seizure protocol with age-based doses is just as safe as current practice, since the seizures may stop faster and these doses are safely used in children in other healthcare settings. If this study demonstrates that standardized, age-based midazolam dosing is equally safe and more effective in comparison to current practice, the potential impact of this study is a shift in the treatment of pediatric seizures that can be easily implemented in ambulance services across the United States and in other parts of the world.
San Francisco, California and other locations
RNS System LGS Feasibility Study
open to eligible people ages 15 years and up
To generate preliminary safety and effectiveness data for brain-responsive neurostimulation of thalamocortical networks as an adjunctive therapy in reducing the frequency of generalized seizures in individuals 12 years of age or older with Lennox Gastaut Syndrome (LGS) who are refractory to antiseizure medications. The intent is to determine the feasibility and the optimal design of a subsequent pivotal study in order to expand the indication for use for the RNS System as a treatment for patients with medically intractable LGS.
San Francisco, California and other locations
XEN496 (Ezogabine) in Children With KCNQ2 Developmental and Epileptic Encephalopathy
open to eligible people ages 1 month to 6 years
To investigate the potential antiseizure effects of adjunctive XEN496 (ezogabine) compared with placebo in children with KCNQ2 Developmental and Epileptic Encephalopathy (KCNQ2-DEE).
San Francisco, California and other locations
Neonatal Seizure Registry - Developmental Functional EValuation
open to eligible people ages 2-8
The NSR-DEV study is a longitudinal cohort study of around 280 Neonatal Seizure Registry participants that aims to evaluate childhood outcomes after acute symptomatic neonatal seizures, as well as examine risk factors for developmental disabilities and whether these are modified by parent well-being.
San Francisco, California and other locations
Neonatal Seizure Registry, GEnetics of Post-Neonatal Epilepsy
open to all eligible people
The NSR-GENE study is a longitudinal cohort study of approximately 300 parent-child trios from the Neonatal Seizure Registry and participating site outpatient clinics that aims to evaluate whether and how genes alter the risk of post-neonatal epilepsy among children with acute provoked neonatal seizures. The researchers aim to develop prediction rules to stratify neonates into low, medium, and high risk for post-neonatal epilepsy based on clinical, electroencephalogram (EEG), magnetic resonance imaging (MRI), and genetic risk factors.
San Francisco, California and other locations
A Study to Investigate the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) as an Adjunctive Therapy in Children and Adults With Lennox-Gastaut Syndrome
Sorry, in progress, not accepting new patients
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).
San Francisco, California and other locations
A Study to Investigate the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Children and Adults With Epileptic Encephalopathy Including Dravet Syndrome and Lennox-Gastaut Syndrome
Sorry, in progress, not accepting new patients
This is an international, multicenter, open-label, long-term safety study of ZX008 in subjects with Dravet syndrome, Lennox-Gastaut syndrome or epileptic encephalopathy
San Francisco, California and other locations
RESTORE: buRst-supprESsion TO Stop Refractory Status Epilepticus Post-cardiac Arrest
Sorry, not yet accepting patients
RESTORE is a randomized clinical trial investigating the safety and feasibility of using EEG treatment targets (burst suppression vs. seizure suppression) for post-cardiac arrest refractory status epilepticus treatment.
San Francisco, California
Roll-over Study to Collect and Assess Long-term Safety of Everolimus in Patients With TSC and Refractory Seizures Who Have Completed the EXIST-3 Study [CRAD001M2304] and Who Are Benefitting From Continued Treatment
Sorry, in progress, not accepting new patients
The purpose of this study is to evaluate the long-term safety in patients with TSC and refractory seizures who are currently receiving everolimus treatment in the Novartis-sponsored EXIST-3 study and who are determined to be benefiting from continued treatment as judged by the investigator at the completion of EXIST-3
Oakland, California and other locations
Evaluating the Role of Inflammation in Neonatal Epileptogenesis
Sorry, in progress, not accepting new patients
The purpose of this study evaluate the relationship between inflammation and epilepsy in neonates with seizures after birth.
Oakland, California and other locations
Our lead scientists for Seizures research studies include Ernesto Gonzalez-Giraldo, MD Adam L Numis, MD Hannah C. Glass, MDCM, MAS Nicolaus Glomb, MD, MPH.
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