MedTrace Logo

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

NCT02088957 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2018-07-11

Study results available
· View outcomes & findings →

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

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

Sponsors & Collaborators

  • PRA Health Sciences

    collaborator INDUSTRY

  • UCB BIOSCIENCES, Inc.

    lead INDUSTRY

Principal Investigators

  • UCB Clinical Trial Call Center · +1 877 822 9493 (UCB)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02088957 on ClinicalTrials.gov