NCT02088957

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: UCB BIOSCIENCES, Inc. · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nonconvulsive Electrographic Seizures

Interventions

Type	Name	Description
DRUG	Brivaracetam intravenous solution	* Active Substance: Brivaracetam * Pharmaceutical Form: Solution for infusion * Concentration: 10 mg/mL * Route of Administration: Intravenous bolus use
DRUG	Brivaracetam oral tablets	* Active Substance: Brivaracetam * Pharmaceutical Form: Film-coated tablet * Concentration: 10 mg and 25 mg tablets; Daily Dose: 200 mg/day (100 mg bid) * Route of Administration: Oral use
DRUG	Phenytoin intravenous solution	* Active Substance: Phenytoin * Pharmaceutical Form: Solution for infusion * Concentration: 50 mg/mL * Route of Administration: Intravenous use
DRUG	Phenytoin oral tablets	* Active Substance: Phenytoin * Pharmaceutical Form: Tablet * Concentration: Weight based * Route of Administration: Oral use

Timeline

• Start date: 2014-03-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2014-03-17
• Last updated: 2018-07-11
• Results posted: 2016-04-13

Locations

2 sites across 1 country: United States