A Study to Assess the Efficacy and Safety of Brivaracetam as Treatment for Increased Seizure Activity in an Epilepsy Monitoring Unit Setting

Completed · Phase 2

Conditions studied: Epilepsy

In brief

The purpose of this study is to assess the efficacy of intravenous brivaracetam (BRV) compared to intravenous lorazepam (LZP) in subjects with epilepsy undergoing Epilepsy Monitoring Unit (EMU) evaluation who experience seizures that require prompt treatment.

Key facts

Study ID: NCT03021018
Run by: UCB Biopharma S.P.R.L.
People needed: 46
Starts: 2017-02-06
Expected to finish: 2018-04-27
Last updated by the study team: 2020-12-16

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subject is male or female, 18 to 70 years of age, inclusive
Subject has an established diagnosis of epilepsy
Subject has been admitted to the institution's Epilepsy Monitoring Unit (EMU) for seizure characterization or noninvasive presurgical evaluation or such admission is planned within 21 days of Screening

You may not qualify if…

Subject has previously participated in this study and was treated with study drug. Re-screen is permitted
Subject has participated in another study of an investigational medicinal product (IMP) or a medical device within the previous 30 days of Epilepsy Monitoring Unit (EMU) admission or is currently participating in another study of an IMP or a medical device
Subject has taken brivaracetam (BRV) in the 21 days prior to EMU admission
History or presence of status epilepticus during the 6 months prior to EMU admission
Subject has a medical or psychiatric condition that in the opinion of the Investigator could jeopardize or would compromise the subject's ability to participate in this study
Subject has > 2x upper limit of normal (ULN) of any of the following: alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, or > ULN total bilirubin
Subject has chronic liver disease
Subject has hypersensitivity to BRV or any of its excipients
Subject has a history of alcohol or drug abuse during the 6 months prior to EMU admission
Subject with a history of psychogenic seizures
Subject is a pregnant or lactating female
Subject has a history of a significant Adverse Event (AE) due to a benzodiazepine in the opinion of the Investigator
Subject has respiratory failure (or is at risk for respiratory failure), untreated sleep apnea, or other severe cardiorespiratory disease with New York Heart Association Class III or IV functional status, or requires supplemental oxygen
Subject has acute narrow-angle glaucoma or myasthenia gravis
Subject is receiving benzodiazepine treatment (defined as an average of >=4 administrations per week) that started less than 28 days prior to EMU admission
Subject has a known allergic reaction or intolerance to benzodiazepines or benzodiazepine excipients

Where it is running

Ep0087 108 — Birmingham, Alabama, United States
Ep0087 117 — Tucson, Arizona, United States
Ep0087 112 — Orlando, Florida, United States
Ep0087 115 — Chicago, Illinois, United States
Ep0087 113 — Chicago, Illinois, United States
Ep0087 119 — Wichita, Kansas, United States
Ep0087 116 — Belmont, Massachusetts, United States
Ep0087 106 — Boston, Massachusetts, United States
Ep0087 107 — Detroit, Michigan, United States
Ep0087 125 — Lebanon, New Hampshire, United States
Ep0087 120 — Rochester, New York, United States
Ep0087 121 — Chapel Hill, North Carolina, United States
Ep0087 105 — Charlotte, North Carolina, United States
Ep0087 123 — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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