To evaluate the safety of Levetiracetam IV 15-minute infusion administered every 12 hours as adjunctive treatment in subjects with Partial Onset Seizures after switching from the equivalent Levetiracetam oral dose.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
* Formulation: concentrate for solution for infusion * Strength: Levetiracetam injection (100 mg/mL) will be packed in 5 mL glass vials (500 mg/5 mL) * Dosage: 1000 mg/day, 1500 mg/day, 2000 mg/day, 2500 mg/day or 3000 mg/day * Frequency: twice daily
1
Niigata, Niigata, Japan
2
Shizuoka, Shizuoka, Japan
3
Kodaira, Tokyo, Japan
4
Yamagata-city, Yamagata, Japan
Incidence of Treatment Emergent Adverse Events During the Entire Study Period (up to 32 Days)
An Adverse Event (AE) is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Time frame: During the entire Study Period from Screening (Day -14 to Day -1) over Evaluation Period (Day 1 to Day 4) to Follow-Up Period (Day 5 to Day 18)
Incidence of Treatment Emergent Serious Adverse Events During the Entire Study Period (up to 32 Days)
A Serious Adverse Event (SAE) is any untoward medical occurrence that results in death, is life-threatening, results in significant or persistent disability/incapacity, is a congenital anomaly/birth defect (including that occurring in a fetus), or is an important medical event that may jeopardize the subject or may require medical or surgical intervention.
Time frame: During the entire Study Period from Screening (Day -14 to Day -1) over Evaluation Period (Day 1 to Day 4) to Follow-Up Period (Day 5 to Day 18)
Observed Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 1
Plasma sample for determination of Plasma trough concentration of Levetiracetam was taken prior to intravenous infusion of Levetiracetam in the morning of Day 1.
Time frame: Day 1
Observed Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 4
Plasma sample for determination of Plasma trough concentration of Levetiracetam was taken prior to intravenous infusion of Levetiracetam in the morning of Day 4.
Time frame: Day 4
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Dose Normalized Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 1
Plasma sample for determination of Plasma trough concentration of Levetiracetam was taken prior to intravenous infusion of Levetiracetam in the morning of Day 1. Plasma trough concentration (Ctrough) was normalized to a dose of 500 mg as follows: Dose normalized Ctrough = Ctrough/last dose \[mg\] x 500 mg.
Time frame: Day 1
Dose Normalized Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 4
Plasma sample for determination of Plasma trough concentration of Levetiracetam was taken prior to intravenous infusion of Levetiracetam in the morning of Day 4. Plasma trough concentration (Ctrough) was normalized to a dose of 500 mg as follows: Dose normalized Ctrough = Ctrough/last dose \[mg\] x 500 mg.
Time frame: Day 4
Partial (Type 1) Seizure Frequency Per Day Over the Evaluation Period
Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures.
Time frame: During the Evaluation Period (Day 1 to Day 4)