A Study to Evaluate the Safety and Tolerability of Intrav... | NCT03685630

Status Module

Label	Type	Description	Intervention Names
Brivaracetam	Experimental	Subjects in this arm will receive open-label Brivaracetam.	Drug: Brivaracetam

Name	Type	Description	Arm Group Labels	Other Names
Brivaracetam	Drug	Pharmaceutical form: Solution for injection Concentration: 10 mg/ml Route of administration: Intravenous injection	Brivaracetam

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Partial seizure frequency during the Treatment Period	Partial Seizures can be classified into one of the following three groups: Simple Partial Seizures, Complex Partial Seizures, Partial Seizures evolving to Secondarily Generalized Seizures. The partial seizure frequency will be assessed using the seizure count information recorded on the daily record card (DRC). The written information will be discussed with the subject in order to ensure completeness and accuracy. As a result of the discussion, the Investigator will assess the seizures according to the International League Against Epilepsy (ILAE) codes and record the seizure types and frequency on the DRC.

Eligibility Module

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
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)

Facility	Status	City	State	ZIP	Country	Contacts
Ep0118 116		Asaka			Japan
Ep0118 126

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases