A Clinical Trial to Evaluate Safety and Tolerability of Lacosamide Injection for the treatment of epilepsy
- Conditions
- Health Condition 1: G401- Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with simple partial seizures
- Registration Number
- CTRI/2011/07/001888
- Lead Sponsor
- Torrent Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse Event Assessment <br/ ><br>Local adverse events at injection site <br/ ><br>Changes in vital signs <br/ ><br>Changes in ECG finding <br/ ><br>Changes in laboratory parameters <br/ ><br>Timepoint: During every administration for 5 days and at the end of 12 days of first administration
- Secondary Outcome Measures
Name Time Method Maintenance of seizure frequency during trial periodTimepoint: During 5 day treatment period