| Rank |
Status |
Study |
| 1 |
Recruiting
|
Efficacy of Intravenous Levetiracetam in Neonatal Seizures
| Condition: |
Neonatal Seizures |
| Interventions: |
Drug: Intravenous levetiracetam; Drug: Intravenous phenobarbital |
| Outcome Measures: |
To determine the efficacy of intravenous LEV in terminating neonatal seizures when given as first line therapy compared to phenobarbital; To obtain dose escalation data by studying the additional efficacy of a further dose in non responders.; To evaluate the benefit of remote EEG monitoring; Evaluation of the accuracy of neonatal seizure detection algorithm |
|
| 2 |
Recruiting
|
Efficacy Evaluation of Intravenous Brivaracetam and Phenytoin in Subjects With Nonconvulsive Electrographic Seizures
| Condition: |
Nonconvulsive Electrographic Seizures |
| Interventions: |
Drug: Brivaracetam intravenous solution; Drug: Brivaracetam oral tablets; Drug: Phenytoin intravenous solution; Drug: Phenytoin oral tablets |
| Outcome Measures: |
Percentage of subjects with seizure freedom for 12 hours starting 1 hour after the end of the last acute intravenous (iv) administration of study drug and prior to the initiation of bid (twice a day) dosing; Percentage of subjects with seizure freedom for 12 hours starting after the end of the last acute intravenous (iv) administration of study drug and prior to the initiation of bid (twice a day) dosing; Time to achievement of 12 hours of seizure freedom relative to the start of the first acute intravenous (iv) administration; Time to achievement of 12 hours of seizure freedom relative to the start of the last acute intravenous (iv) administration that occurred prior to the initiation of bid (twice a day) dosing; Percentage of subjects requiring a second acute intravenous (iv) administration between 15 minutes to 12 hours after first acute iv administration; Time to first onset of seizure cessation relative to the start of the first acute intravenous (iv) administration |
|
| 3 |
Recruiting
|
Remegal Fixed Dose as Adjunctive Therapy in Patients With Partial Seizures
| Conditions: |
Epilepsy; Simple Partial Seizures; Complex Partial Seizures; Partial Seizures With Secondary Generalization |
| Intervention: |
Drug: Remegal |
| Outcome Measures: |
Seizure Frequency Reduction; Number of Seizure's-Free Days; CGI; PGI; QOLIE |
|
| 4 |
Recruiting
|
Seizure Detection and Warning System for Epilepsy Patients
| Condition: |
Epilepsy |
| Intervention: |
Device: Night Watch Seizure Detection Device and Warning System |
| Outcome Measures: |
Primary outcome is accuracy of device to detect GTC seizures when compared to video EEG.; Comparison of study device to self reporting of seizures using a seizure diary. |
|
| 5 |
Recruiting
|
Phase 2 Study of Adjunctive Ganaxolone in Adults With Drug-resistant Partial Onset Seizures, With Long-term Open-label Extension
| Condition: |
Drug Resistant Partial Onset Seizure |
| Interventions: |
Drug: ganaxolone; Drug: Placebo |
| Outcome Measures: |
Percentage change in seizure frequency per 28 days in the double blind period relative to baseline; Change in seizure frequency per 28 days; Proportion of responders experiencing a ≥50% reduction from baseline to the end of the period, in total partial seizure frequency per 28 days; Proportion of seizure free subjects; Clinical Global Impression of change; Patient Global Impression of change; Change in the number of seizure-free days |
|
| 6 |
Recruiting
|
Respiratory Physiology in Children With Febrile Seizures.
| Conditions: |
Febrile Illness in Children; Seizures, Febrile |
| Intervention: |
|
| Outcome Measures: |
Change of transcutaneous pCO2 per change of body temperature [mmHg/degree C]; Change of respiratory rate per change of body temperature [1/sec * degree C]; Change of transcutaneous pCO2 per change of respiratory rate [mmHg * sec] |
|
| 7 |
Not yet recruiting
|
A Safety, Efficacy, and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric Subjects <4 Years of Age With Partial Onset Seizures.
| Condition: |
Partial Onset Seizures |
| Interventions: |
Drug: Pregabalin Dose Level 1; Drug: Pregabalin Dose Level 2; Drug: Placebo |
| Outcome Measures: |
Percent reduction of 24 hour seizure rate for all partial onset seizures relative to placebo during the double-blind assessment phase.; Responder rate, defined as the proportion of subjects who had at least a 50% reduction in 24 hour partial onset seizure rate. |
|
| 8 |
Recruiting
|
A 12-Month Study To Evaluate The Safety And Tolerability Of Pregabalin As Add-On Therapy In Pediatric Subjects 1 Month To 16 Years Of Age With Partial Onset Seizures And Pediatric And Adult Subjects 5 To 65 Years Of Age With Primary Generalized Tonic-Clonic Seizures
| Condition: |
Epilepsy, Partial Seizures |
| Intervention: |
Drug: Pregabalin |
| Outcome Measures: |
SAE's (serious adverse event) and AE's (adverse events); Vital signs; Physical exams to assess change from baseline for physical state of limbs, torso, and organs and Neurological exams to assess change from baseline for measures of peripheral and central nervous system function.; Clinical laboratory data (hematology , chemistry, urinalysis; Electrocardiograms; Suicidality assessments; Cognitive testing |
|
| 9 |
Recruiting
|
Pilot Study of Bumetanide for Newborn Seizures
| Condition: |
Seizures |
| Interventions: |
Drug: Bumetanide; Other: Normal Saline |
| Outcome Measures: |
The primary outcome is determination of the pharmacokinetics and safety of bumetanide in newborns with refractory seizures.; A secondary outcome is determination of the feasibility of a novel study design to test antiepileptic drugs to treat neonatal seizures caused by acute hypoxic-ischemic encephalopathy in a clinical trial. |
|
| 10 |
Recruiting
|
Intravenous Lacosamide Compared With Fosphenytoin in the Treatment of Patients With Frequent Nonconvulsive Seizures
| Condition: |
Nonconvulsive Seizures |
| Interventions: |
Drug: Lacosamide - 'Crossover'; Drug: Fosphenytoin - 'crossover' |
| Outcome Measures: |
Percentage of subjects who experience no NCSs for 24 hours following treatment with LCM vs. fPHT, as measured by continuous electroencephalography (cEEG) monitoring.; Percentage of subjects who require a rebolus of the initial antiepileptic drug (AED) to control NCSs in the LCM vs fPHT arms.; Percentage of subjects who require a second AED to control NCSs.; Percent change in seizure time (defined as the number of minutes of electrographic seizure (ESz) activity per hour) before treatment and at the end of the first treatment arm.; Percent change in seizure time (defined as the number of minutes of ESz activity per hour) before treatment and at the end of the second treatment arm.; Time from bolus to time of the end of the last seizure for both first (initial bolus/rebolus)and second (crossover bolus/rebolus) treatment arms.; Frequency of predefined adverse events (AEs) in the LCM vs fPHT arms.; Percentage of subjects in whom study drug is withdrawn early; Days in the intensive care unit/hospital from start of treatment in the LCM vs fPHT arms.; Functional status as measured by the Functional Disability Scale at Day 7 to 9 postrandomization and Day 30 post-randomization in the LCM vs fPHT arms.; Percentage of all subjects who have had a seizure, are on AED therapy, and are alive/dead at the 6-, 12-, and 24-month post-randomization follow-ups. |
|
| 11 |
Recruiting
|
A Safety, Efficacy and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric and Adult Subjects With Primary Generalized Tonic-Clonic (i.e., Grand Mal) Seizures.
| Condition: |
Generalized Tonic Clonic Seizures |
| Interventions: |
Drug: Pregabalin Dose Level 1; Drug: Pregabalin Dose Level 2; Drug: Placebo |
| Outcome Measures: |
Percent reduction of 28 day seizure rate for all PGTC seizures relative to placebo during the double blind assessment phase.; Responder rate, defined as the proportion of subjects who had at least a 50% reduction in 28 day PGTC seizure. |
|
| 12 |
Unknown †
|
Safety and Feasibility of Using Epicall for Monitoring Pre-seizure Biomarkers
| Condition: |
Seizure |
| Intervention: |
Device: Epicall |
| Outcome Measures: |
Lack of adverse events; Epicall feasibility for monitoring pre-seizure biomarkers |
|
| 13 |
Unknown †
|
Efficacy and Safety of Levetiracetam in Partial Seizures Control, With or Without Secondary Generalization
| Conditions: |
Epilepsy; Partial Seizures |
| Interventions: |
Drug: Levetiracetam; Drug: Placebo |
| Outcome Measures: |
Partial onset seizure frequency per week.; Safety descriptive about occurence of adverse events, evaluation of results of clinical/physical examination and ECG and laboratory tests results.; Proportions of response between the groups of treatment. (Responders defined as number of patients with at least 50% reduction in the number of weekly partial seizures); Percentage reduction from baseline in partial seizure frequency of days a week.; Proportion of response between the groups of treatment. (Responders defined as number of subjects with at least 50% reduction in the number of days per week with partial seizures); Proportion between the groups of treatment without any kind of seizures. (seizure free) |
|
| 14 |
Recruiting
|
A Study of the Efficacy and Safety of Pregabalin as Add-On Therapy for Partial Onset Seizures in Children Ages 4-16 Years
| Condition: |
Epilepsy, Partial Seizures |
| Intervention: |
Drug: Pregabalin add-on therapy |
| Outcome Measures: |
Log transformed (loge) 28 day seizure rate for all partial onset seizures collected during the 12 week double-blind treatment phase, reported as "percent reduction in seizures" relative to placebo.; Responder Rate, defined as subjects who have a 50% or greater reduction in partial seizure rate from baseline during the double-blind treatment phase. |
|
| 15 |
Recruiting
|
A Placebo-controlled Study of Efficacy & Safety of 2 Trough-ranges of Everolimus as Adjunctive Therapy in Patients With Tuberous Sclerosis Complex (TSC) & Refractory Partial-onset Seizures
| Condition: |
Tuberous Sclerosis Complex-associated Refractory Seizures |
| Interventions: |
Drug: RAD001; Drug: Placebo |
| Outcome Measures: |
European Medicine Agency (EMA): Response rate; Food & Drug Administration (FDA): Percentage reduction in partial onset seizure frequency; Seizure free rate; Proportion of patients with at least a 25% reduction in partial onset seizure frequency; Categorical variable of six levels of reduction from baseline in partial-onset seizure frequency; Frequency of seizure free days; Treatment duration; Overall Quality of Life global scores; Sub-test scores for neurocognitive, neurodevelopmental, and neurobehavioral tests; Percentage reduction in seizure frequency/frequency of selected adverse events; Pre-dose concentrations of anti-epileptic drugs (AEDs) alone and post-baseline (AEDs plus everolimus); 50% response rate from Baseline by time interval over the extension phase; Seizure free days in partial onsent seizure by time interval over the extension phase; Frequency of adverse events; Frequency of abnormal laboratory values; Frequency of Columbia Suicide Severity Rating Scale (C-SSRS) outcomes; Frequency of serious adverve events (SAEs) referring to a positive suicidal evaluation |
|
| 16 |
Recruiting
|
Open-label, Randomized, Active-controlled Study of LEV Used as Monotherapy in Patients With Partial-Onset Seizures
| Conditions: |
Epilepsy; Partial Seizures |
| Interventions: |
Drug: Levetiracetam; Drug: Carbamazepine |
| Outcome Measures: |
Proportion of subjects remaining seizure free during the 6-months Evaluation Period; Proportion of subjects retained in the study for the duration of the period covering the Up Titration Period, Stabilization Period, and Evaluation Period; Time to first seizure or discontinuation due to an Adverse Event (AE) / Lack of Efficacy (LOE) during the Evaluation Period; Time to first seizure during the Evaluation Period; Time to first seizure during the period covering the Up Titration Period, Stabilization Period, and Evaluation Period from the first dose of study drug |
|
| 17 |
Not yet recruiting
|
Evaluating the Efficacy of Magnetic Seizure Therapy in Treatment Resistant Depression.
| Condition: |
Depressive Disorder |
| Interventions: |
Device: Magnetic seizure therapy; Device: Electroconvulsive therapy |
| Outcome Measure: |
Hamilton Rating Scale for Depression, 24-item (HRSD-24) |
|
| 18 |
Unknown †
|
Seizures After Cardiac Surgery -- A Study With Continuous EEG Monitoring
| Condition: |
Non-convulsive Seizures |
| Intervention: |
|
| Outcome Measure: |
Frequency of non-convulsive seizures in postoperative cardiac surgery patients |
|
| 19 |
Recruiting
|
A Study With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Perampanel (E2007) Administered as an Adjunctive Therapy in Subjects With Refractory Partial-onset Seizures
| Condition: |
Partial-onset Seizures |
| Interventions: |
Drug: E2007; Drug: Placebo |
| Outcome Measure: |
The percent change in seizure frequency per 28 days in the Randomization Phase relative to the Prerandomization Phase |
|
| 20 |
Unknown †
|
Efficacy of Keppra in Acute Alcohol Related Seizure Control--A Pilot Study
| Condition: |
Seizure, Alcohol Related |
| Intervention: |
Drug: levetiracetam |
| Outcome Measure: |
Decreased seizures |
|
