A Multicenter, Open-Label, Non-Comparative Clinical Trial toEvaluate Safety and Tolerability of Lacosamide Injection in Patients withPartial Onset Seizures

Torrent Pharmaceuticals Ltd0 个研究点目标入组 200 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Patients with known allergic reaction or intolerance to study drugs and/or
•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
•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

发起方

Torrent Pharmaceuticals Ltd