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

Information source: UCB Pharma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Nonconvulsive Electrographic Seizures

Intervention: Brivaracetam intravenous solution (Drug); Brivaracetam oral tablets (Drug); Phenytoin intravenous solution (Drug); Phenytoin oral tablets (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: UCB BIOSCIENCES, Inc.

Official(s) and/or principal investigator(s):
UCB Clinical Trial Call Center, Study Director, Affiliation: +1 877 822 9493 (UCB)

Summary

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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

Secondary outcome:

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 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

Eligibility

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

3, Lexington, Kentucky, United States

1, Jackson, Mississippi, United States

Additional Information

Starting date: March 2014
Last updated: July 21, 2015

Page last updated: August 23, 2015

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