Efficacy Evaluation of Intravenous Brivaracetam and Phenytoin in Subjects With Nonconvulsive Electrographic Seizures

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02088957
• Date of registration: 20/02/2014
• Prospective Registration: Yes
• Primary sponsor: UCB BIOSCIENCES, Inc.
• Public title: Efficacy Evaluation of Intravenous Brivaracetam and Phenytoin in Subjects With Nonconvulsive Electrographic Seizures
• Scientific 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
• Date of first enrolment: March 2014
• Target sample size: 1
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02088957
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: UCB Clinical Trial Call Center
• Affiliation: [phone] (UCB)

Key inclusion & exclusion criteria

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



Age minimum: 16 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Nonconvulsive Electrographic Seizures

Intervention(s)

Drug: Phenytoin oral tablets

Drug: Brivaracetam intravenous solution

Drug: Phenytoin intravenous solution

Drug: Brivaracetam oral tablets

Primary Outcome(s)

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 [Time Frame: 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 Outcome(s)

Percentage of Subjects Requiring a Second Acute Intravenous (iv) Administration Between 15 Minutes to 12 Hours After First Acute iv Administration [Time Frame: 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 [Time Frame: From start of first acute 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 [Time Frame: 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)]

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 [Time Frame: 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)]

Time to Achievement of 12 Hours of Seizure Freedom Relative to the Start of the First Acute Intravenous (iv) Administration [Time Frame: From start of first acute iv administration on Day 1]

Secondary ID(s)

N01394

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

PRA Health Sciences

Results

• Results available: Yes
• Date Posted: 13/04/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02088957