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Safety and Tolerability of Intravenous Brivaracetam (Infusion or Bolus) as Adjunctive Antiepileptic Therapy | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Safety and Tolerability of Intravenous Brivaracetam (Infusion or Bolus) as Adjunctive Antiepileptic Therapy

A Multi-center, Open-label, Four-arm, Randomized Trial Evaluating the Safety and Tolerability of Brivaracetam Intravenous Infusion and Bolus, Administered in BID Regimen as an Adjunctive Antiepileptic Treatment in Subjects From 16 to 70 Years Suffering From Epilepsy

NCT01405508•UCB Pharma

View on ClinicalTrials.gov

Summary

This is a multicenter, open-label, 4-arm, randomized, parallel-group study to evaluate safety and tolerability of Brivaracetam Intravenous (BRV iv) as adjunctive treatment for adults with epilepsy according to an initiation or a conversion scheme, during repeated dosing (100 mg/administration twice daily for 4.5 days).

Detailed Description

Eligible subjects will be randomized in a 1:1:1:1 ratio to the 4 treatment arms

Eligibility

Age

16 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•An Institutional Review Board/Independent Ethics Committee (IRB/IEC) approved written Informed Consent form signed and dated by the subject or by parent(s) or legal representative
•Subjects from 16 to 70 years
•Subjects with a body weight of \>/= 40 kg
•Female subjects without childbearing potential or female subjects with childbearing potential if they use a medically accepted contraceptive method
•Subject/legal representative considered as reliable and capable of adhering to the protocol
•Subjects with well-characterized focal or generalized epilepsy or epileptic syndrome
•Subjects with a history of partial-onset seizures whether or not secondarily generalized or primary generalized seizures
•Subjects being uncontrolled while treated with 1 to 2 permitted concomitant antiepileptic drugs (AEDs)
•Permitted concomitant antiepileptic drugs (AEDs) and vagus nerve stimulation (VNS) being stable and at optimal dosage for the subject from at least 1 month before Visit 1 and expected to be kept stable during the Run-In and Evaluation Periods

Exclusion Criteria

•Mentally impaired subjects unable to understand the study purpose
•History or presence of status epilepticus during 1 year preceding Visit 1 or Baseline
•Subjects on felbamate with less than 18 months continuous exposure before Visit 1
•Subjects currently on vigabatrin
•Subject taking any drug with possible relevant central nervous system effects except is stable from at least 1 month before Visit 1 and expected to be kept stable during the trial
•Subjects taking any drug that may significantly influence the metabolism of Brivaracetam (BRV) except if the dose has been kept stable at least 1 month before Visit 1, and is expected to be kept stable during the trial
•History of cerebrovascular accident in the last 6 months
•Subjects suffering from severe cardiovascular disease or peripheral vascular disease
•Presence of any sign suggesting rapidly progressing brain disorder or brain tumor
•Any clinical conditions which impair reliable participation in the study or necessitate the use of medication not allowed by protocol
+19 more criteria

Locations (17)

001

Phoenix, Arizona, United States

775

Little Rock, Arkansas, United States

780

Lexington, Kentucky, United States

008

Bethesda, Maryland, United States

778

Columbus, Ohio, United States

776

Nashville, Tennessee, United States

777

Dallas, Texas, United States

036

Charlottesville, Virginia, United States

917

Brno, Czechia

915

Hradec Králové, Czechia

Key Dates

Start Date

August 1, 2011

Primary Completion Date

July 1, 2012

Completion Date

July 1, 2012

Last Updated

July 11, 2018

Enrollment

105

ACTUAL participants

Conditions

Epilepsy

Interventions

Brivaracetam tablets

DRUG

Brivaracetam bolus

DRUG

Brivaracetam infusion

DRUG

Placebo

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 11, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety and Tolerability of Intravenous Brivaracetam (Infusion or Bolus) as Adjunctive Antiepileptic Therapy

Inclusion Criteria

Exclusion Criteria

Thalamus Seizure Detection With a Deep Brain Stimulator System

Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy

Intracranial Investigation of Neural Circuity Underlying Human Mood

Late-Onset Seizures: Trial of Vascular Risk Investigation and Treatment

AI-Based Mobile Intervention on Medication Non-Adherence and Transition

MEHMO Natural History and Biomarkers