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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
* Pharmaceutical form: Solution for injection * Concentration: 10 mg/ml * Route of administration: Intravenous injection
Ep0118 116
Asaka, Japan
Ep0118 126
Bunkyō City, Japan
Ep0118 111
Hamamatsu, Japan
Ep0118 121
Itami, Japan
Ep0118 142
Kamakura, Japan
Ep0118 112
Kōshi, Japan
Ep0118 104
Shizuoka, Japan
Ep0118 138
Tsukuba, Japan
Ep0118 109
Yamagata, Japan
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.
Time frame: 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.
Time frame: 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
Time frame: From study entry until Final Visit (up to 7 days)
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.
Time frame: During the Treatment Period (from Day 1 to Day 5)
Brivaracetam (BRV) plasma concentration (at Day 1)
The plasma concentration level of brivaracetam 5 minutes postdose on Day 1.
Time frame: Day 1
Brivaracetam (BRV) plasma concentration (at Day 2)
The plasma concentration level of brivaracetam 5 minutes postdose on Day 2.
Time frame: Day 2
Brivaracetam (BRV) plasma concentration (at Day 5)
The plasma concentration level of brivaracetam 5 minutes postdose on Day 5.
Time frame: Day 5
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.