Health Condition 1: G401- Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with simple partial seizures
Conditions
Interventions
Intervention1: Lacosamide: Intravenous (Lacosamide injection would be administered as 30-60min infusion at 12-hr interval for 5 days).
Sponsors
Torrent Pharmaceuticals Ltd
Not Applicable
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients aged 17 years and above with confirmed diagnosis of epilepsy suffering from Partial Onset Seizures, who are on oral Lacosamide and can be temporarily switched over to intravenous Lacosamide 2. Patients willing to give written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients with abnormal platelet count and unacceptable to intravenous injections 2. Patients with seizures occurring in clusters 3. Patients with Status Epilepticus within 3 months of enrolment 4. Patients with history of non-epileptic seizures 5. Patients with known allergic reaction or intolerance to study drugs and/or excipients 6. Patients with liver enzymes more than 2.5X the normal value and/or bilirubin more than 1.5X the normal value and/or serum creatinine more than the upper limit of the normal value 7. Patients with progressive structural lesions in the central nervous system or progressive encephalopathy, progressive neurological disorders like multiple sclerosis, Guillain-Barre syndrome 8. Patients with cardiac conduction defects and on drugs that can prolong P-R interval 9. Patients with clinically important ECG abnormalities 10. Patients with serious psychiatric disorders like Schizophrenia, Bipolar disorder with suicidal tendencies 11. Use of neuroleptics, MOA inhibitors, barbiturates, or narcotic analgesics within 28 days prior to screening 12. Patients who have participated in any other investigational drug trial within the four weeks preceding study entry 13. Women patient of childbearing potential, not practicing medically acceptable (non-hormonal) method of contraception 14. Pregnant or lactating women, children and adolescents below 17 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Event Assessment Local adverse events at injection site Changes in vital signs Changes in ECG finding Changes in laboratory parameters Timepoint: During every administration for 5 days and at the end of 12 days of first administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Maintenance of seizure frequency during trial periodTimepoint: During 5 day treatment period | — |
Countries
India
Contacts
Public ContactDr Ripal Gharian
Outcome results
None listed