A comparative Clinical trial to study the effect of two drugs, lacosamide & levetiracetam in patients with refractory epilepsy suffering from partial onset seizures with or without secondary generalization.
- Conditions
- Health Condition 1: G401- Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with simple partial seizures
- Registration Number
- CTRI/2009/091/000668
- Lead Sponsor
- Torrent Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 216
1. Male and female patients between 17 and 70 years of age (both inclusive) with confirmed refractory epilepsy suffering from partial onset seizures with or without secondary generalization and maintaining a stable dose regimen of at least one Anti-epileptic drug (AED) for one month before screening
2. Documented history of patients with minimum 2 seizures in past two months, with at least 1 seizure in last one month.
1. Patients unable/unwilling to give informed written consent
2. Patients with seizures occurring in clusters
3. Patients with Status Epilepticus within 3 months of enrollment
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 neurological disorders like multiple sclerosis,
Guillain-Barre syndrome
8. Presence of significant cardiac dysfunction or clinically important ECG
abnormalities
9. Patients with serious psychiatric disorders like Schizophrenia, Bipolar disorder
with suicidal tendencies
10. Use of neuroleptics, MOA inhibitors, barbiturates, or narcotic analgesics
within 28 days prior to screening
11. Patients who have participated in any other investigational drug trial within
the four weeks preceding study entry
12. Women patient of childbearing potential, not practicing medically acceptable
(non-hormonal) method of contraception
13. 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
- Secondary Outcome Measures
Name Time Method