Health Condition 1: G400- Localization-related (focal) (partial) idiopathic epilepsy and epileptic syndromes with seizures of localized onset
Conditions
Interventions
Intervention1: Lacosamide: Lacosamide will be administered as monotherapy via oral route in children with newly diagnosed focal epilepsy. The drug will be initiated at a low dose and titrated graduall
Sponsors
Dr Mahavirsinh Parmar
Eligibility
Inclusion criteria
Inclusion criteria: Age 2 to 18 years 2 Clinical diagnosis of focal epilepsy with or without secondary generalization ILAE criteria supported by EEG and/or MRI when available. 3. more than or equal to 2 unprovoked focal seizures in the prior 6 months OR one unprovoked seizure with high recurrence risk where treatment is indicated. 4. ASM naive or not on current daily ASM (rescue benzodiazepine use permitted).
Exclusion criteria
Exclusion criteria: History of status epilepticus requiring ICU admission. 2. Generalized epilepsy syndrome or epileptic spasms. 3. Known hypersensitivity to OXC or LCM. 4. Significant cardiac conduction disease second/third-degree AV Block, baseline PR interval more 95th percentile for age, or symptomatic bradycardia. 5. Prior use of both study drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the efficacy of Lacosamide with oxcarbazepine at 24 weeks in children with newly diagnosed or previously untreated focal epilepsy. Timepoint: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Compare time to first seizure freedom more than or equal to 4 consecutive weeks without seizures after reaching target dose. Compare percentage reduction in monthly focal seizure frequency from baseline to Weeks 12 & 24. Compare treatment emergent adverse events, serious adverse events, & discontinuations due to AE. Timepoint: At baseline, week 12 & week 24 | — |
Countries
India
Contacts
Public ContactKapil Jetha
AIIMS Rajkot
Outcome results
None listed