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Efficacy of Lacosamide and Topiramate on Control of Neonatal Refractory Seizures

Comparison of the Safety and Efficacy of Lacosamide and Topiramate on Control of Neonatal Refractory Seizures

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230415057911N2
Enrollment
54
Registered
2024-03-16
Start date
2023-03-01
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

Neonatal Seizure. Convulsions of newborn

Interventions

Intervention 1: Intervention group 1: Infants receive Lacosamide tablets (manufactured by Dr. Abidi Company, Iran) twice a day at a dosage of 2 mg/kg/day, If no treatment response, 2 mg/kg is added to

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Days to 3 Months

Inclusion criteria

Inclusion criteria: Neonates with seizure who did not respond to phenobarbital (dose40 mg/kg) and Levebel (40 mg/kg). Infants under 3 months with refractory seizures whose seizures have started since infancy (under one month). Seizures due to secondary abnormalities in asphyxia, brain structural disorders, familial seizures, congenital and acquired infections, vascular lesions

Exclusion criteria

Exclusion criteria: Seizures that started after neonatal Period Seizures due to secondary abnormalities in metabolic disorders or electrolyte disorders.

Design outcomes

Primary

MeasureTime frame
The incidence of seizures. Timepoint: Before the intervention, 3 days and 7 days after the intervention. Method of measurement: Electroencephalography (EEG).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Vafaeeshahi

Iran University of Medical Sciences

vafaeeshahi.m@iums.ac.ir+98 21 2304 6253

Outcome results

None listed

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