A Multicenter, Open-Label, Non-Comparative Clinical Trial to Evaluate Safety and Tolerability of Lacosamide Injection in Patients with Partial Onset Seizures - NI

Torrent Pharmaceuticals Ltd0 个研究点目标入组 60 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 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

•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

发起方

Torrent Pharmaceuticals Ltd