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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Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
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 ≥…
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=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=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=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=6 VIGABatrin in Post-anoxic STATus Epilepticus - Phase IIa
Status Epilepticus, Electrographic · Coma
Primary: Primary Pharmacologic Outcome - Absorption — 6; 0 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=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 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=358 Intranasal Midazolam Versus Rectal Diazepam for Treatment of Seizures
Seizures
Primary: Length of Seizure After Study Medication Administration — 3.0; 4.3 Minutes
Phase 3 N=653 Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) as Adjunctive Therapy for Refractory Partial Seizures
Partial Epilepsy
Primary: Seizure Frequency Over the 12-week Maintenance Period. — 7.88; 6.54; 6.00 Nº Standardized Seizures by 4 weeks — p=0.058
Phase 2 N=39 Electroconvulsive Therapy in Clozapine Refractory Schizophrenia
Schizophrenia
Primary: Response Rates in the ECT Plus Clozapine Group vs the Pharmacotherapy Group. — 50; 0 Percentage of responders
Phase 3 N=539 Retigabine Efficacy and Safety Trial for Partial Onset Refractory Seizures in Epilepsy
Seizures
Primary: Percent Change in the 28-day Total Partial Seizure (PS) Frequency From Baseline (BL) to the End of the Double-blind (DB) Phase (Titration and Maintenance Phases)…
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 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=304 Eslicarbazepine Acetate (BIA 2 093) as Therapy for Refractory Partial Seizures in Children
Partial Epilepsy in Children and Adolescents
Primary: Change From Baseline in Seizure Frequency — 62.0; 36.6 seizures/month — p=0.2490
Phase 3 N=306 Retigabine (Adjunctive Therapy) Efficacy and Safety Study for Partial Onset Refractory Seizures in Epilepsy
Seizures
Primary: Percent Change in the 28-day Total Partial Seizure (PS) Frequency From Baseline (BL) to the End of the Double-blind (DB) Phase (Titration and Maintenance Phases)…
Phase 3 N=422 The MENDS2 Study, Maximizing the Efficacy of Sedation and Reducing Neurological Dysfunction and Mortality in Septic Patients With Acute Respiratory Failure
Sepsis · Delirium · Impaired Cognition
Primary: Delirium/Coma Free Days (DCFDs) — 8; 7.5 days
Phase 3 N=130 Safety and Tolerability Study of Diazepam Buccal Film (DBF) in Subjects With Epilepsy
Epilepsy
Primary: Number of Subjects in the Safety Analysis Set With at Least 1 Treatment-emergent Adverse Event (TEAE) — 84; 14; 10; 1 Participants
Phase 2 N=22 Abnormal Ventilatory Response to Carbon Dioxide: a Potential Biomarker for Seizure Induced Respiratory Depression & Modification by SSRI
Epilepsy · SUDEP
Primary: Study Recruitment Rate — 3.8 participants/3 months
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 2 N=46 A Study to Assess the Efficacy and Safety of Brivaracetam as Treatment for Increased Seizure Activity in an Epilepsy Monitoring Unit Setting
Epilepsy
Primary: Time to Next Seizure (Per Clinical Observation With Electroencephalogram [EEG] Confirmation) or Rescue Medication — NA; NA; NA hours
Phase 3 N=402 Efficacy and Safety of Eslicarbazepine Acetate as Adjunctive Therapy for Refractory Partial Seizures
Refractory Partial Epilepsy
Primary: Part I: Seizure Frequency — 7.64; 6.73; 5.66; 5.35 ln (Seizures) per 4 weeks
N/A N=20 Treatment Resistant Depression (Pilot)
Depressive Disorder, Treatment-Resistant
Primary: Montgomery-Asberg Depression Rating Scale (MADRS) Total Score — -9.0; -6.4 Scores on a scale — p=0.53
Phase 2 N=21 A Long-term Extension Study of E2007 in Patients With Refractory Partial Seizures Uncontrolled With Other Anti-Epileptic Drugs (AEDs)
Refractory Partial Seizures
Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel — 21; 11…
Phase 2 N=7 Mechanisms of Refractory Hypertension (Reserpine)
Refractory Hypertension
Primary: Change Ambulatory Systolic Blood Pressure — -29.3 mmHg
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=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 2 N=30 An add-on Study of E2007 in Patients With Refractory Partial Seizures Uncontrolled With Other Anti-epileptic Drugs (AEDs)
Refractory Partial Seizures
Primary: Maximum Tolerated Dose (MTD) — 0; 2; 1; 6 Participants