Safety and Tolerability study of Lacosamide Injection in Patients withPartial Onset Seizures.
- Conditions
- Health Condition 1: G401- Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with simple partial seizures
- Registration Number
- CTRI/2014/12/005260
- Lead Sponsor
- Torrent Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 200
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ï?? Adverse event assessment <br/ ><br>ï?? Local adverse events at injection site <br/ ><br>ï?? Clinically significant changes in vital signs <br/ ><br>ï?? Clinically significant changes in ECG finding i.e. Prolongation in PR interval, Prolongation in QTc interval, arrhythmia, etc. <br/ ><br>ï?? Clinically significant changes in laboratory parameters <br/ ><br>ï?? Assessment of seizure frequency <br/ ><br>Timepoint: Baseline (Day 0) to end of study treatment (Day 5)
- Secondary Outcome Measures
Name Time Method ILTimepoint: NI