A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Intravenous Brivaracetam as Replacement for Oral Brivaracetam in Japanese Subjects >=16 Years of Age With Partial Seizures With or Without Secondary Generalization
Overview
- Phase
- Phase 3
- Intervention
- Brivaracetam
- Conditions
- Partial Seizures With or Without Secondary Generalization
- Sponsor
- UCB Biopharma S.P.R.L.
- Enrollment
- 10
- Locations
- 9
- Primary Endpoint
- Adverse Events (AEs) as reported spontaneously by the subject or observed by the Investigator
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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 any medical condition which, in the Investigator's opinion, warrants exclusion
- •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
Arms & Interventions
Brivaracetam
Subjects in this arm will receive open-label Brivaracetam.
Intervention: Brivaracetam
Outcomes
Primary Outcomes
Adverse Events (AEs) as reported spontaneously by the subject or observed by the Investigator
Time Frame: From study entry until Final Visit (up to 7 days)
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.
Subject withdrawal due to Adverse Events (AEs)
Time Frame: From study entry until Final Visit (up to 7 days)
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.
Occurrence of Serious Adverse Events (SAEs)
Time Frame: From study entry until Final Visit (up to 7 days)
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
Secondary Outcomes
- Brivaracetam (BRV) plasma concentration (at Day 2)(Day 2)
- Brivaracetam (BRV) plasma concentration (at Day 5)(Day 5)
- 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)