Phase 3 N=478 Established Status Epilepticus Treatment Trial
Benzodiazepine Refractory Status Epilepticus
Primary: Number of Participants With Clinical Cessation of Status Epilepticus - Intention to Treat — 53; 56; 68 Participants
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Phase 3 N=100 Randomized Therapy In Status Epilepticus
Status Epilepticus
Primary: Percentage of Participants With SE Cessation Within 30 Minutes of Investigational Product (IP) Initiation Without Medications for the Acute Treatment of SE — 79.59…
Phase 3 N=26 Lorazepam for the Treatment of Status Epilepticus or Repetitive Status Epilepticus in Japan
Status Epilepticus
Primary: Percentage of Participants Who Achieved Seizure Free Interval of At Least 30 Minutes After Initial Dose (Dose 1) of Study Drug — 48.0 percentage of participants
Phase 2 N=17 Intravenous Ganaxolone as Adjunctive Therapy to Treat Subjects With Status Epilepticus
Status Epilepticus · Convulsive Status EPILEPTICUS · Non Convulsive Status Epilepticus
Primary: Number of Participants Who Did Not Require an IV Anesthetic Drug for SE Treatment — 5; 4; 8 Participants
Phase 3 N=132 A Study With SAGE-547 for Super-Refractory Status Epilepticus
Super-Refractory Status Epilepticus
Primary: Number of Participants Able to be Weaned Off All Third-Line Agents Prior to End of Double-Blind SAGE-547 or Placebo Infusion, and Remain Off All Third-Line Agents for ≥…
N/A N=20 EEG Cap for Identification of Non-Convulsive Status Epilepticus
Nonconvulsive Status Epilepticus · Subclinical Seizure · Altered Mental Status
Primary: Time Difference Between EEG Cap and Standard EEG Results Reporting — 103.4 minutes — p=0.0005
Phase 2 N=6 VIGABatrin in Post-anoxic STATus Epilepticus - Phase IIa
Status Epilepticus, Electrographic · Coma
Primary: Primary Pharmacologic Outcome - Absorption — 6; 0 Participants
Phase 2 N=25 Study to Evaluate SAGE-547 Injection as Adjunctive Therapy for the Treatment of Super-Refractory Status Epilepticus
Super-refractory Status Epilepticus
Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) — 17; 6 Participants
Phase 3 N=3 Study of Midazolam Hydrochloride Oromucosal Solution (MHOS/SHP615) in Pediatric Patients With Status Epilepticus (Convulsive) in the Community Setting
Nervous System Diseases
Primary: Efficacy: Number of Participants With Therapeutic Success — 3 Participants
Phase 3 N=25 Open-label Study of Midazolam Hydrochloride Oromucosal Solution (MHOS/SHP615) in Children With Status Epilepticus (Convulsive) in a Healthcare Setting in Japan
Nervous System Diseases
Primary: Percentage of Participants With Response Rate — 80.0 Percentage of participants
Phase 3 N=893 Paramedic Treatment of Prolonged Seizures by Intramuscular Versus Intravenous Anticonvulsant Medications
Status Epilepticus
Primary: Number of Subjects With Termination of Seizures at ED Arrival With no Rescue Therapy Given — 329; 282 participants — p=<0.001
Phase 2 N=125 Anti-epileptogenic Effects of Eslicarbazepine Acetate
Post Stroke Epilepsy
Primary: Proportion of Patients Who Experience the First Unprovoked Seizures (US) Within the First 6 Months After Randomisation (Failure Rate) — 2; 7; 3; 0 Participants
N/A N=12,386 Clinical and Economic Burden of Uncontrolled Epilepsy: Analyses From a Medicaid Database and a Private Health Plan Database
Epilepsy
Primary: Average Annualized Costs — 1352; 462; 1357; 1050 United States dollars — p=<0.0001
Phase 3 N=62 Study to Evaluate the Safety and Efficacy of USL261 in Patients With Increased Bouts of Seizure Activity in the EMU
Epilepsy
Primary: Number of Participants That Were Seizure-free — 17; 12 Participants — p=0.1972
Phase 3 N=251 A Double-blind, Placebo-controlled Study of Levetiracetam in Epilepsy Patients With Generalized Tonic-clonic Seizures (Except Partial Seizures Evolving to Secondarily Generalized Seizures)
Epilepsy · Generalized Tonic-Clonic Seizures
Primary: Percentage Change From the Combined Baseline in the Generalized Tonic-clonic Seizure Frequency Per Week Over the 28-week Treatment Period (Dose Adjustment + Evaluation…
Phase 3 N=193 Safety and Efficacy of Eslicarbazepine Acetate Monotherapy in Subjects With Partial Epilepsy Not Well Controlled by Current Antiepileptic Drugs
Epilepsy With Simple or Complex Partial Onset Seizures
Primary: Cumulative 112-day Exit Rate as Estimated by Kaplan-Meier Method — 0.444; 0.287 proportion of participants
Phase 3 N=172 Safety & Efficacy of Eslicarbazepine Monotherapy in Sub.w/Partial Epilepsy Not Well Controlled by Current Antiepileptic
Epilepsy
Primary: Cumulative 112-day Exit Rate as Estimated by Kaplan-Meier Method — 0.156; 0.128 proportion of participants
Phase 2 N=24 Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-827104 in Pediatric Subjects With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep
Epileptic Encephalopathy · Continuous Spike and Wave During Sleep
Primary: Ratio of Spike-Wave Index (SWI) During First Hour of Nonrapid Eye Movement (NREM) Sleep at Week 6 — -0.02; 0.01 Log-transformed ratio — p=0.4326
N/A N=44 Seizure Detection Using SEDline During Therapeutic Hypothermia in Cardiac Arrest Victims
Cardiac Arrest
Primary: Percentage of Seizure-positive and Seizure-negative That Were Correctly Classified by the SEDline in All Evaluated Cases — 100 percentage of seizures
Phase 3 N=44 An Open Label Study of L059 (Levetiracetam) in Japanese Epilepsy Subjects With Generalized Tonic-clonic Seizures
Epilepsy · Generalized Tonic-clonic Seizures
Primary: Incidence of Treatment Emergent Adverse Events During the Entire Study Period — 626 Treatment Emergent Adverse Events
Phase 2 N=7 Thalidomide Low Threshold in Epilepsy
Refractory Epilepsy
Primary: Change From Baseline in the Mean Number of Daily Seizures at 1 Year. — 9 Number of Seizures — p=<0.02
Phase 2 N=156 Inpatient, Dose-Ranging Study of Staccato Alprazolam in Epilepsy With Predictable Seizure Pattern
Epilepsy
Primary: Percentage of Participants in Each Treatment Group Achieving Seizure Activity Cessation Within 2 Minutes and no Recurrent Seizure Within 2 Hours — 62.5; 42.5; 65.8; 65.8…
Phase 2 N=7 PF-06372865 in Subjects With Photosensitive Epilepsy
Reflex Epilepsy, Photosensitive
Primary: The Standardized Photosensitivity Range (SPR) in the Subject's Most Sensitive Eye Condition — 0.57; 1.38; 1.58; 6.80 Units on a scale
N/A N=20 The Effect on Cognition of Terminating ECT Induced Seizures With Propofol
Major Depression
Primary: Wechsler Memory Scale-III (WMS-III) Auditory Delayed Index
Phase 3 N=239 Safety and Efficacy of Lacosamide as Additional Therapy in Patients Suffering From Epileptic Tonic-Clonic Seizures
Epilepsy
Primary: Number of Study Participants With Treatment-emergent Adverse Events (TEAEs) Over the Duration of the Treatment Period — 222 Participants
Phase 2 N=147 A Randomized, Controlled Trial of Ganaxolone in Adult Uncontrolled Partial-Onset Seizures
Partial Epilepsy · Catamenial Epilepsy
Primary: Mean Weekly Log-transformed Seizure Frequency During Weeks 1 Through 10 — 5.20; 10.77 log[seizures per week]
Phase 2 N=74 Intravenous Lacosamide Compared With Fosphenytoin in the Treatment of Patients With Frequent Nonconvulsive Seizures
Nonconvulsive Seizures
Primary: Percentage of Subjects Who Experience no Nonconvulsive Seizures (NCS) for 24 Hours Following Treatment With LCM vs. fPHT, as Measured by Continuous…
Phase 3 N=234 Efficacy and Safety of Diazepam in the Management of Refractory Epilepsy in Selected Patients Who Require Intermittent Medical Intervention for Acute Repetitive Seizures.
Seizures · Epilepsies, Partial · Epilepsy, Complex Partial
Primary: Time to Next Seizure or Rescue Medication During the Double-blind Period (Kaplan-Meier 50th Percentile) — 5.92; NA Hours — p=0.012
Phase 3 N=253 Efficacy and Safety of Eslicarbazepine Acetate as Adjunctive Therapy for Refractory Partial Epilepsy
Partial Epilepsy
Primary: Seizure Frequency — 7.3; 5.7; 5.5 ln (Seizures) per 4 weeks
Phase 4 N=103 Levetiracetam Versus Valproate in Idiopathic Generalized Tonic-clonic Seizures
Epilepsy, Idiopathic Generalized
Primary: Time to First Seizure — 169; 178 Days