A Study to Evaluate the Safety and Tolerability of Intravenous Brivaracetam (BRV) as Replacement for Oral Brivaracetam in Japanese Subjects >=16 Years of Age With Partial Seizures With or Without Secondary Generalization

NCT03685630 | Completed Phase 3

• 1 other identifier: EP0118
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 9

Brief Summary

The purpose of the study is to evaluate the safety and tolerability of intravenous (iv) brivaracetam (BRV) as adjunctive therapy administered as a replacement for oral BRV at doses ranging from BRV 50 mg/day to 200 mg/day in Japanese subjects \>=16 years of age with partial seizures with or without secondary generalization and to evaluate the partial seizure frequency after switching from oral administration to iv BRV.

Conditions

Partial Seizures With or Without Secondary Generalization; Epilepsy

Keywords

Brivaracetam; Epilepsy; Partial seizures with or without secondary generalization; Japanese subjects

Outcome Measures

Primary Outcomes (3)

• Adverse Events (AEs) as reported spontaneously by the subject or observed by the Investigator

  An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.

  From study entry until Final Visit (up to 7 days)

• Subject withdrawal due to Adverse Events (AEs)

  An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.

  From study entry until Final Visit (up to 7 days)

• Occurrence of Serious Adverse Events (SAEs)

  A SAE must meet 1 or more of the following criteria: * Death * Life-threatening * Significant or persistent disability/incapacity * Congenital anomaly/birth defect * Initial inpatient hospitalization or prolongation of hospitalization * Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or subject and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious

  From study entry until Final Visit (up to 7 days)

Secondary Outcomes (4)

• Partial seizure frequency during the Treatment Period

  During the Treatment Period (from Day 1 to Day 5)

• Brivaracetam (BRV) plasma concentration (at Day 1)

  Day 1

• Brivaracetam (BRV) plasma concentration (at Day 2)

  Day 2

• Brivaracetam (BRV) plasma concentration (at Day 5)

  Day 5

Study Arms (1)

Brivaracetam

EXPERIMENTAL

Subjects in this arm will receive open-label Brivaracetam.

Drug: Brivaracetam

Interventions

Brivaracetam DRUG

* Pharmaceutical form: Solution for injection * Concentration: 10 mg/ml * Route of administration: Intravenous injection

Also known as: Briviact

Brivaracetam

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has, in the opinion of the Investigator, adequate seizure control for participation in the study, and is willing and able to comply with all study requirements including hospitalization, multiple blood draws, and intravenous (iv) injection
• Female subjects without childbearing potential (postmenopausal for at least 2 years, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible. Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method
• Japanese subject is currently enrolled in EP0085 \[NCT03250377\] receiving oral brivaracetam (BRV) for the treatment of partial seizures and has been enrolled for at least 8 weeks prior to entry into EP0118
• Subject has been on a stable twice daily dosage regimen of BRV 50 mg/day to 200 mg/day for the 4 weeks prior to entry into EP0118
• Subject has been receiving concomitant antiepileptic drug (AED(s)) at doses that have remained stable for the 4 weeks (12 weeks for phenobarbital, phenytoin, and primidone) prior to entry into EP0118
• Subject has been receiving drugs with possible central nervous system (CNS) effects at doses that have remained stable for the 4 weeks prior to entry into EP0118, if applicable
• Subject has been receiving drugs that significantly influence the metabolism of BRV at doses that have remained stable for the 4 weeks prior to entry into EP0118, if applicable
• Subject has had stable vagal nerve stimulation (VNS) settings for the 4 weeks prior to entry into EP0118, if applicable

You may not qualify if:

• Subject is receiving an investigational medicinal product (IMP) or unapproved medication other than oral BRV, or using an experimental medical device
• Subject has previously been treated with intravenous (iv) brivaracetam (BRV)
• Subject has a known hypersensitivity to any components of the investigational medicinal product (IMP) or comparative drugs as stated in this protocol
• Subject has a confirmed clinically relevant abnormality by electrocardiogram (ECG)
• Subject has a severe medical, neurological, or psychiatric disorder, or abnormal laboratory values which may have an impact on the safety of the subject
• Subject has demonstrated poor compliance with the visit schedule or medication intake in previous BRV studies
• Subject has planned participation in any other clinical study of another IMP or device during this study
• Subject is a pregnant or lactating female
• Subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) "Since Last Visit" at Screening
• Subject has \>2x upper limit of normal (ULN) of any of the following prior to Day 1 (from liver function assessment in EP0085): alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or \>ULN total bilirubin (\>=1.5x ULN total bilirubin if known Gilbert's syndrome)

Sponsors & Collaborators

• UCB Biopharma S.P.R.L.: lead

Study Sites (9)

Ep0118 116

Asaka, Japan

Location

Ep0118 126

Bunkyō City, Japan

Location

Ep0118 111

Hamamatsu, Japan

Location

Ep0118 121

Itami, Japan

Location

Ep0118 142

Kamakura, Japan

Location

Ep0118 112

Kōshi, Japan

Location

Ep0118 104

Shizuoka, Japan

Location

Ep0118 138

Tsukuba, Japan

Location

Ep0118 109

Yamagata, Japan

Location

MeSH Terms

Conditions

Epilepsy

Interventions

brivaracetam

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• UCB Cares

  001 844 599 2273 (UCB)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: September 26, 2018
• Study Start: January 4, 2019
• Primary Completion: March 27, 2021
• Study Completion: March 27, 2021
• Last Updated: April 13, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (9)