Safety and Efficacy Study of Cenobamate in Pediatric Subjects 2-17 Years of Age With Partial-onset (Focal) Seizures
Recruiting
Primary objective: To evaluate the safety and tolerability of cenobamate in pediatric subjects 2-17 years of age with partial-onset (focal) seizures
Gender:
All
Ages:
Between 2 years and 18 years
Trial Updated:
11/22/2023
Locations: Mayo Clinic - Rochester, Rochester, Minnesota
Conditions: Partial Epilepsy
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Lacosamide in Neonates With Repeated Electroencephalographic Neonatal Seizures
Recruiting
The purpose of the study is to evaluate the efficacy of lacosamide (LCM) versus 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.
Gender:
All
Ages:
28 days and below
Trial Updated:
11/20/2023
Locations: Sp0968 103, Rochester, Minnesota
Conditions: Electroencephalographic Neonatal Seizures, Epilepsy
Medtronic Deep Brain Stimulation (DBS) Therapy for Epilepsy Post-Approval Study (EPAS)
Recruiting
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.
Gender:
All
Ages:
18 years and above
Trial Updated:
11/13/2023
Locations: Mayo Clinic (Rochester MN), Rochester, Minnesota
Conditions: Epilepsy
Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Cenobamate Adjunctive Therapy in PGTC Seizures
Recruiting
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 cenobamate or placebo (study drug) and increase the dose every two weeks until they reach a target dos... Read More
Gender:
All
Ages:
12 years and above
Trial Updated:
10/27/2023
Locations: Minneapolis Clinic of Neurology Golden Valley, Golden Valley, Minnesota
Conditions: Primary Generalized Epilepsy
Optimization of Deep Brain Stimulation Parameters in Patients With Medically Refractory Epilepsy
Recruiting
Deep brain stimulation (DBS) is used to treat epilepsy in cases where patients are medically refractory and are not candidates for surgical resection. This therapy has been shown to be effective in seizure reduction, yet very few patients achieve the ultimate goal of seizure freedom. Implantable neural stimulators (INSs) have many parameters that may be adjusted, and could be tuned to achieve very patient specific therapies. This study will develop a platform for stimulation setting optimization... Read More
Gender:
All
Ages:
18 years and above
Trial Updated:
10/06/2023
Locations: University of Minnesota, Minneapolis, Minnesota
Conditions: Refractory Epilepsy, Deep Brain Stimulation
RNS System NAUTILUS Study
Recruiting
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.
Gender:
All
Ages:
12 years and above
Trial Updated:
08/10/2023
Locations: Mayo Clinic - Rochester, Rochester, Minnesota
Conditions: Epilepsy, Idiopathic Generalized Epilepsy, Generalized Tonic Clonic Seizure
Genetic Markers of Cardiovascular Disease in Epilepsy
Recruiting
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... Read More
Gender:
All
Ages:
Between 18 years and 50 years
Trial Updated:
08/01/2023
Locations: Mayo Clinic, Rochester, Minnesota
Conditions: Epilepsy, Seizures, Syncope, Channelopathy, Cardiomyopathies
Pivotal-Safety and Therapeutic Measures of tDCS in Patients With Refractory Focal Epilepsy
Recruiting
This is a multiple site, randomized, double blinded parallel-group controlled study. The purpose of this study is to evaluate efficacy, safety, and tolerability of repeated, daily sessions with the STARSTIM device, which delivers transcranial cathodal direct current stimulation (tDCS). Subjects will be treated with STARTSTIM or sham device for 10 sessions over a 2-week period. The subjects will be followed for an additional 10 weeks post treatment. Quality of Life questionnaires and adverse even... Read More
Gender:
All
Ages:
9 years and above
Trial Updated:
07/21/2023
Locations: Mayo Clinic, Rochester, Minnesota
Conditions: Refractory Epilepsy, Focal Seizure, Seizures, Focal, Seizures, Epilepsy in Children, Epilepsy, Epilepsy, Tonic-Clonic
Intracranial Stimulation Mapping In Epilepsy
Recruiting
This is a single group prospective study to determine the feasibility for generating brain maps that localize cerebral functions and inter-regional information flow in partial epilepsy in adult patients.
Gender:
All
Ages:
18 years and above
Trial Updated:
06/21/2023
Locations: University of Minnesota, Minneapolis, Minnesota
Conditions: Epilepsy
Neural Circulatory Control and SUDEP Risk.
Recruiting
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.
Gender:
All
Ages:
Between 18 years and 90 years
Trial Updated:
06/05/2023
Locations: Mayo Clinic, Rochester, Minnesota
Conditions: Epilepsy, Seizures
Study of Transcranial Direct Current Stimulation to Treat Epilepsy
Recruiting
The purpose of this research is to see to what extent electrical stimulation applied to the scalp (transcranial direct current stimulation or tDCS) can reduce the number and intensity of epileptic seizures.
Gender:
All
Ages:
18 years and above
Trial Updated:
05/22/2023
Locations: Mayo Clinic Minnesota, Rochester, Minnesota
Conditions: Focal Epilepsy
Human Epilepsy Project 3
Recruiting
By carrying a careful, large-scale and ambitious prospective study of a cohort of participants with generalized epilepsy, the study team hopes to clarify the likelihood of response and remission in this type of epilepsy, and try to explore the underlying biological drivers of treatment response, including novel realms of exploration such as impact of the microbiome, and genetics. The identification of biomarkers that predict the likelihood of disease response would allow epilepsy patients to mak... Read More
Gender:
All
Ages:
13 years and above
Trial Updated:
03/28/2023
Locations: Mayo Clinic, Rochester, Minnesota +1 locations
Conditions: Idiopathic Generalized Epilepsy