Nonconvulsive Electrographic Seizures Clinical Trial
Official title:
A Randomized, Open-label, Multicenter, Parallel-group, Exploratory Study to Evaluate the Efficacy of Intravenous Brivaracetam and Intravenous Phenytoin in Subjects Experiencing Nonconvulsive Electrographic Seizures
| NCT number | NCT02088957 |
| Other study ID # | N01394 |
| Secondary ID | |
| Status | Terminated |
| Phase | Phase 2 |
| First received | |
| Last updated | |
| Start date | March 2014 |
| Est. completion date | October 2014 |
| Verified date | July 2016 |
| Source | UCB Pharma |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The primary objective of this study is to compare the efficacy of Brivaracetam and Phenytoin, both administered intravenously, in adult subjects experiencing nonconvulsive electrographic seizures.
| Status | Terminated |
| Enrollment | 1 |
| Est. completion date | October 2014 |
| Est. primary completion date | October 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 16 Years and older |
| Eligibility |
Inclusion Criteria: - Subjects =16 years. Subjects under 18 years may only be included where legally permitted and ethically accepted - Subjects in the neurological intensive care unit (NICU) (or equivalent closely monitored environment) having brain insult including traumatic brain injury and having nonconvulsive electrographic seizures (NCES) confirmed by electroencephalogram (EEG), lasting a minimum of 10 seconds but not >30 minutes (minimum of 1 seizure in the last 6 hours) and treatment with an antiepileptic drug (AED) is required according to the physician's clinical judgment - Subject is expected to be under cEEG monitoring with video surveillance in the Neuro ICU for at least 36 hours from the first administration of study drug Exclusion Criteria: - Subject has history of severe adverse hematologic or cutaneous reaction to any drug - Subject presenting with status epilepticus or nonconvulsive status epilepticus (NCSE) (ie, 1 continuous, convulsive or nonconvulsive, unremitting seizure lasting >30 minutes during Visit 1) - Subject has been diagnosed with anoxic brain injury - Subject has a known history of status epilepticus during the 6 months preceding Visit 1 - Subject is currently treated with Levetiracetam (LEV) or Phenytoin (PHT) or has been treated within the last 30 days before Visit 1 with LEV or PHT - Subject is on felbamate with <18 months' exposure before Visit 1 - Subject has presence of any sign (clinical or imaging techniques) suggesting a rapidly progressing process such that the subject is not expected to survive >48 hours - Subject has any clinical condition that would impair reliable participation in the study or necessitate the use of medications not allowed by the protocol |
| Country | Name | City | State |
|---|---|---|---|
| United States | 1 | Jackson | Mississippi |
| United States | 3 | Lexington | Kentucky |
| Lead Sponsor | Collaborator |
|---|---|
| UCB BIOSCIENCES, Inc. | PRA Health Sciences |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Subjects With Seizure Freedom for 12 Hours Based on cEEG/vEEG Monitoring Which Starts 1 Hour After the End of the Last Acute iv Administration of Study Drug and Prior to the Initiation of Bid (Twice a Day) Dosing | Seizure freedom is based on cEEG/vEEG (continuous video electroencephalogram) monitoring. | From 1 hour after end of the last acute iv administration of study drug and prior to initiation of bid dosing (which begins 12 hours after the last acute iv administration of study drug) | |
| Secondary | Percentage of Subjects With Seizure Freedom for 12 Hours Based on cEEG/vEEG Monitoring Which Starts After the End of the Last Acute Intravenous (iv) Administration of Study Drug and Prior to the Initiation of Bid (Twice a Day) Dosing | Seizure freedom is based on cEEG/vEEG (continuous video electroencephalogram) monitoring. | From end of the last acute iv administration of study drug and prior to initiation of bid dosing (which begins 12 hours after the last acute iv administration of study drug) | |
| Secondary | Time to Achievement of 12 Hours of Seizure Freedom Relative to the Start of the First Acute Intravenous (iv) Administration | Seizure freedom is based on cEEG/vEEG (continuous video electroencephalogram) monitoring. | From start of first acute iv administration on Day 1 | |
| Secondary | 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 | Seizure freedom is based on cEEG/vEEG (continuous video electroencephalogram) monitoring. | From start of last acute iv administration prior to initiation of bid dosing (which begins 12 hours after the last acute iv administration of study drug) | |
| Secondary | Percentage of Subjects Requiring a Second Acute Intravenous (iv) Administration Between 15 Minutes to 12 Hours After First Acute iv Administration | Between 15 minutes to 12 hours after first acute iv administration | ||
| Secondary | Time to First Onset of Seizure Cessation Relative to the Start of the First Acute Intravenous (iv) Administration | Seizure cessation is based on cEEG/vEEG (continuous video electroencephalogram) monitoring. | From start of first acute iv administration |