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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03021018
• Date of registration: 11/01/2017
• Prospective Registration: Yes
• Primary sponsor: UCB Biopharma S.P.R.L.
• Public title: A Study to Assess the Efficacy and Safety of Brivaracetam as Treatment for Increased Seizure Activity in an Epilepsy Monitoring Unit Setting
• Scientific 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
• Date of first enrolment: February 6, 2017
• Target sample size: 46
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03021018
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United Kingdom, United States

Contacts

• Name: UCB Cares
• Affiliation: UCB ([phone])

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Epilepsy

Intervention(s)

Drug: Brivaracetam

Drug: Lorazepam

Primary Outcome(s)

Time to Next Seizure (Per Clinical Observation With Electroencephalogram [EEG] Confirmation) or Rescue Medication [Time Frame: During the Treatment Period (Day 1) until Safety Follow-Up Visit (Day 2)]

Secondary Outcome(s)

Percentage of Subjects Who Receive Rescue Medication During the 12 Hours After the End of Study Drug Administration [Time Frame: During the 12 hours after the end of study drug administration]

Percentage of Subjects Who Receive Rescue Medication During the 6 Hours After the End of Study Drug Administration [Time Frame: During the 6 hours after the end of study drug administration]

Percentage of Subjects Who Receive Rescue Medication During the 8 Hours After the End of Study Drug Administration [Time Frame: During the 8 hours after the end of study drug administration]

Percentage of Subjects Who Are Seizure-free Per Clinical Observation at 12 Hours After the End of Study Drug Administration [Time Frame: At 12 hours after the end of study drug administration]

Percentage of Subjects Who Are Seizure-free Per Clinical Observation at 8 Hours After the End of Study Drug Administration [Time Frame: At 8 hours after the end of study drug administration]

Time to Next Seizure (Per Clinical Observation) or Rescue Medication [Time Frame: During the Treatment Period (Day 1) until Safety Follow-Up Visit (Day 2)]

Percentage of Subjects Who Are Seizure-free Per Clinical Observation at 6 Hours After the End of Study Drug Administration [Time Frame: At 6 hours after the end of study drug administration]

Secondary ID(s)

EP0087

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 28/05/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03021018