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Clinical Studies
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A 57-Week, Multicenter, Active-Treatment, Open-Label Extension Trial of CVL-865 as Adjunctive Therapy in Adults With Drug-Resistant Focal Onset Seizures
Jacksonville, Fla.
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.
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A Double-Blind, Placebo-Controlled, Inpatient, Dose-Ranging Efficacy Study of Staccato Alprazolam (STAP-001) in Subjects With Epilepsy With a Predictable Seizure Pattern (StATES)
Jacksonville, Fla.
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 study medication. The duration and timing of the seizure event and occurrence of subsequent seizures will be assessed by the Staff Caregiver(s)1 through clinical observation and confirmed with video electroencephalogram (EEG).
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A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Intravenous Ganaxolone in Status Epilepticus (RAISE)
Rochester, Minn.,
Jacksonville, Fla.
The purpose of this study is to establish the effectiveness and safety of IV ganaxolone for the treatment of Status Epilepticus (SE) after failure of first-line benzodiazepines and two second-line IV antiepileptic drugs (AEDs)
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A Phase IV, Prospective, Randomized, Open-Label, Parallel Study Evaluating the Effect of an Adjunctive Anti-Seizure Medication using a Glutaminergic Modulator in Patients with Drug-Resistant Focal Epilepsy and High-Grade Glioma
Jacksonville, Fla.
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.
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A Pivotal, Phase III Trial of Detecting Generalized Tonic-Clonic Seizures with a Seizure Detection and Warning System in Epilepsy Patients
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
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.
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A Randomized, Double Blind, Placebo Controlled, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of XEN1101 as Adjunctive Therapy in Focal Onset Epilepsy, with an Open-label Extension
Jacksonville, Fla.
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).
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A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Trial of CVL-865 as Adjunctive Therapy in Adults With Drug-Resistant Focal Onset Seizures (REALIZE Trial) (REALIZE)
Jacksonville, Fla.
The purpose of this study is to assess the effectiveness, safety, and tolerability profile of CVL-865 as adjunctive treatment in participants with drug-resistant focal onset seizures.
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Clinical Utility of the SPEAC® System: A Case Series (SPEAC®)
Jacksonville, Fla.
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.
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EEG Cap Placement for Expedited Identification of Non-Convulsive Status Epilepticus
Jacksonville, Fla.
Altered mental status (AMS) is one of the most common reasons for inpatient neurology consultation. Non-convulsive status epilepticus (NCSE) is frequently on the differential diagnosis of the patient with AMS. NCSE becomes more refractory to treatment after one hour of seizure activity, making rapid identification and treatment of NCSE of great clinical importance. Currently, an electroencephalogram (EEG) technologist must be called in from home during non-workday hours in order to obtain a stat EEG. The investigators propose the time required for diagnosis of NCSE at Mayo Clinic can be significantly decreased with rapid placement of an EEG cap by the onsite neurology residents.
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Feasibility Study on Laser Interstitial Thermal Therapy Ablation for the Treatment of Medical Refractory Epilepsy (FLARE) (FLARE)
Jacksonville, Fla.
The purpose of this study is to characterize the use of the Monteris NeuroBlate System for the performance of brain laser interstitial thermal therapy (LITT) ablation treatment of medial temporal lobe epilepsy that is resistant to medical tharapy.
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Microburst VNS Therapy Feasibility Study in Subjects With Refractory Epilepsy (Microburst)
Jacksonville, Fla.
The purpose of this study is to evaluate the initial safety and effectiveness of Microburst VNS stimulation in subjects with refractory epilepsy.
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Predictability of Smartphone Videos in an Outpatient Epilepsy Clinic
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.,
Rochester, Minn.
The purpose of this study is to find out if home-recorded Smartphone videos can be used to accurately diagnose epilepsy in patients seeking evaluation for seizures. The idea is to compare the home-recorded video to video-EEG monitoring, which is the current gold-standard for diagnosis.
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Prophylactic Benzodiazepine versus Reinstitution of Maintenance Antiseizure Drugs following Ictal SPECT
Jacksonville, Fla.
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).
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