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

• Status: Completed
• Trial end date: 2018-04-27
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UCB Biopharma S.P.R.L.
• Treatments: Brivaracetam; Lorazepam

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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