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

Epilepsy Clinical Trial

Official title:

A Multicenter, Open-Label, Randomized, Parallel-Group, Active-Controlled Study to Assess the Efficacy and Safety of Brivaracetam Administered Intravenously as Treatment for Increased Seizure Activity in an Epilepsy Monitoring Unit Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03021018
• Other study ID #: EP0087
• Status: Completed
• Phase: Phase 2
• Start date: February 6, 2017
• Est. completion date: April 27, 2018

Study information

• Verified date: November 2020
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: April 27, 2018
• Est. primary completion date: April 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy
• Seizures

Intervention

Drug:
• Brivaracetam
Pharmaceutical Form: Solution for infusion Concentration: 10 mg/ml Route of Administration: intravenous
• Lorazepam
Pharmaceutical Form: Solution for injection Route of Administration: intravenous

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
UCB Biopharma S.P.R.L.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Next Seizure (Per Clinical Observation With Electroencephalogram [EEG] Confirmation) or Rescue Medication	This variable was calculated in hours. The event of next seizure was defined as the first seizure (clinically observed with electroencephalogram [EEG] confirmation) with the start date and time within 12 hours after the end of investigational medicinal product (IMP) administration.	During the Treatment Period (Day 1) until Safety Follow-Up Visit (Day 2)
Secondary	Time to Next Seizure (Per Clinical Observation) or Rescue Medication	This variable was calculated in hours. The event of next seizure was defined as the first seizure (clinically observed and not necessarily confirmed via electroencephalogram [EEG]) with the start date and time within 12 hours after the end of investigational medicinal product (IMP) administration.	During the Treatment Period (Day 1) until Safety Follow-Up Visit (Day 2)
Secondary	Percentage of Subjects Who Are Seizure-free Per Clinical Observation at 6 Hours After the End of Study Drug Administration	This variable was defined as the number of subjects seizure free during 6 hours after the end of study drug administration divided by the number of subjects in the Intent-to-Treat (ITT) set multiplied by 100.	At 6 hours after the end of study drug administration
Secondary	Percentage of Subjects Who Are Seizure-free Per Clinical Observation at 8 Hours After the End of Study Drug Administration	This variable was defined as the number of subjects seizure free during 8 hours after the end of study drug administration divided by the number of subjects in the ITT set multiplied by 100.	At 8 hours after the end of study drug administration
Secondary	Percentage of Subjects Who Are Seizure-free Per Clinical Observation at 12 Hours After the End of Study Drug Administration	This variable was defined as the number of subjects seizure free during 12 hours after the end of study drug administration divided by the number of subjects in the ITT set multiplied by 100.	At 12 hours after the end of study drug administration
Secondary	Percentage of Subjects Who Receive Rescue Medication During the 6 Hours After the End of Study Drug Administration	This variable was defined as the number of subjects who received rescue medication with start date and time within the first 6 hours after the end of study drug administration divided by the number of subjects in the Intent-to-Treat as randomized (ITT-R) set multiplied by 100.	During the 6 hours after the end of study drug administration
Secondary	Percentage of Subjects Who Receive Rescue Medication During the 8 Hours After the End of Study Drug Administration	This variable was defined as the number of subjects who received rescue medication with start date and time within the first 8 hours after the end of study drug administration divided by the number of subjects in the ITT-R set multiplied by 100.	During the 8 hours after the end of study drug administration
Secondary	Percentage of Subjects Who Receive Rescue Medication During the 12 Hours After the End of Study Drug Administration	This variable was defined as the number of subjects who received rescue medication with start date and time within the first 12 hours after the end of study drug administration divided by the number of subjects in the ITT-R set multiplied by 100.	During the 12 hours after the end of study drug administration

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