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

UCB

Status and phase: Completed; Phase 2

Conditions: Epilepsy

Treatments: Drug: Brivaracetam; Drug: Lorazepam

Study type: Interventional

Funder types: Industry

Identifiers

NCT03021018

EP0087

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

46 participants in 3 patient groups

Brivaracetam (BRV) 100 mg

Experimental group

Description:

Two 5 ml vials of brivaracetam administered intravenously over a 2-minute period

Treatment:

Drug: Brivaracetam

Brivaracetam (BRV) 200 mg

Experimental group

Description:

Four 5 ml vials of brivaracetam administered intravenously over a 4-minute period

Treatment:

Drug: Brivaracetam

Lorazepam (LZP)

Active Comparator group

Description:

Lorazepam bolus is to be injected based on information from the patient leaflet/package insert. The rate of injection should not exceed 2.0 mg/min. The LZP dose will be determined according to the Investigator's clinical judgment.

Treatment:

Drug: Lorazepam