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.

A Multicenter, Randomized Open-Label, Comparative, Prospective Clinical Trial to Investigate Efficacy and Safety of Lacosamide versus Levetiracetam as an Adjunctive Treatment in Patients With Refractory Epilepsy Suffering From Partial Onset Seizures With or Without Secondary Generalization.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000668

Enrollment

216

Registered

2010-01-11

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G401- Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with simple partial seizures

Interventions

Intervention1: Lacosamide IR formulations: to be started with100mg/day for a week and uptiratrated to a maxi of 400mg/day for 8 weeks Control Intervention1: Levetiracetam IR formulation: to be started

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Responder Rate (defined as proportion of patients with a minimum of 50% reduction in seizure frequency from baseline)Timepoint: 9 weeks	—

Secondary

Measure	Time frame
Median percentage reduction in frequency of seizures compared to baseline Number of seizure-free patients during the treatment period Change in QOLIE-31 score Physician?s and patient?s global assessment to the treatmentTimepoint: ;Number of seizure-free patients during the treatment periodTimepoint: 9 week	—

Countries

India

Contacts

Public ContactDr Deepa Joshi

Torrent Pharmaceuticals Ltd

deepajoshi@torrentpharma.com07971315571

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026

A comparative Clinical trial to study the effect of two drugs, lacosamide &amp; levetiracetam in patients with refractory epilepsy suffering from partial onset seizures with or without secondary generalization.