Health Condition 1: G401- Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with simple partial seizures
Conditions
Interventions
Intervention1: Lacosamide: total daily intravenous dosage of Lacosamide should be equivalent to the total daily
dosage and frequency of oral Lacosamide for five days at 12-hr interval
Control Interven
Sponsors
Torrent Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients aged 17 years and above with confirmed diagnosis of Partial Onset Seizures, who are on oral Lacosamide and can be temporarily switched over to intravenous Lacosamide based on investigatorâ??s discretion. 2. Patients willing to give written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients with known allergic reaction or intolerance to study drugs and/or excipients 2. Pregnant or lactating women. 3. Known case of second- or third-degree atrioventricular (AV) block 4. Patients with clinically significant abnormal hematologic profile. 5. Patients with Status Epilepticus within last 3 months of screening 6. Patients with liver enzymes [Aspartate aminotransferase (ALT) & Alanine transaminase (AST)] more than 3.0 X the upper limit of normal value and/or bilirubin more than 1.5X the upper limit of normal value and/or serum creatinine more than the upper limit of the normal value 7. Patients with cardiac conduction defects and on drugs that can prolong P-R interval 8. Patients with clinically significant ECG abnormalities 9. Use of neuroleptics, MAO inhibitors, barbiturates, or narcotic analgesic within 28 days prior to screening 10. Patients who have participated in any other investigational drug trial within 3 months preceding study entry 11. Female patients who are of childbearing potential and who are neither surgically sterilized nor willing to use reliable contraceptive methods (hormonal, barrier methods or intrauterine device) 12. Patients with history of atrial flutter or atrial fibrillation 13. Patient with suicidal ideation or suicidal tendency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ï?? Adverse event assessment ï?? Local adverse events at injection site ï?? Clinically significant changes in vital signs ï?? Clinically significant changes in ECG finding i.e. Prolongation in PR interval, Prolongation in QTc interval, arrhythmia, etc. ï?? Clinically significant changes in laboratory parameters ï?? Assessment of seizure frequency Timepoint: Baseline (Day 0) to end of study treatment (Day 5) | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactDr Sushil Kumar Anand
Torrent Pharmaceuticals Ltd
Outcome results
None listed