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Investigation of therapeutic effect and monotherapy with lacosamide compared to carbamazepine in children with epilepsy

Comparison of therapeutic effects and monotherapy with lacosamide versus carbamazepine in children with newly diagnosed epilepsy

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20231123060147N1
Enrollment
100
Registered
2024-01-12
Start date
2023-12-10
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

Epilepsy. Epilepsy and recurrent seizures

Interventions

Intervention 1: Intervention group: Lacosamide (Unimide brand) was started with a daily dose of 2 mg/kg/day divided into two doses (BD) and continued with an increase of 2 mg/kg/day every week to a ma

Sponsors

Mazandaran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 16 Years

Inclusion criteria

Inclusion criteria: Children aged between 4 and 16 years with newly diagnosed epilepsy

Exclusion criteria

Exclusion criteria: History of liver disease and history of heart disease Receiving antiepileptic medication for more than 48 hours during the last three months Patients with any neurodegenerative or neurometabolic disease causing an allergic reaction Dissatisfaction of the patient and the patient's parents Patients with a history of bone marrow suppression

Design outcomes

Primary

MeasureTime frame
At least a period of 6 months without seizures. Timepoint: For 6 months, the number and type of seizures experienced by the child from the previous visit will be asked. Method of measurement: Observing types of seizures by parents.

Secondary

MeasureTime frame
Drug side effects includes (aplastic anemia - agranulocytosis - liver disorder (increased AST, ALT more than 5 times the normal range) - hyponatremia (Na less than 135). Timepoint: 6 months after drug intervention. Method of measurement: Observation of drug complications includes (aplastic anemia - agranulocytosis - liver dysfunction (increase of AST, ALT above 5 times the normal range) - hyponatremia (Na less than 135).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactKobra Sheidaee

Mazandaran University of Medical Sciences

user.k.s4834@mazums.ac.ir+98 11 3304 4000

Outcome results

None listed

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