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levetiracetam versus carbamazepine monotherapy in the treatment of focal epilepsy of children

levetiracetam versus carbamazepine monotherapy in the treatment of focal epilepsy of children

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015030821355N1
Enrollment
50
Registered
2017-01-12
Start date
2014-07-02
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Epilepsy. Episodic diseases

Interventions

Intervention 1: Control Group: carbamazepine group: This group will be treated with carbamazepine. In carbamazepine group,the drug with the dose of 5 mg/kg/day is initiated and increases 5 mg/kg/wee
Treatment - Drugs
Control Group: carbamazepine group: This group will be treated with carbamazepine. In carbamazepine group,the drug with the dose of 5 mg/kg/day is initiated and increases 5 mg/kg/week. finlay, it re
Intervention Group: levetiracetam group: This group will be treated with levetiracetam. In levetiracetam group,the drug with the dose of10 mg/kg per day is initiated and increases 10 mg/kg/week . fi

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 16 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Children with age over one year and less than sixteen years old with newly diagnosed focal epilepsy, No history of refractory seizures, No history of renal disease, No history of hepatic disease, No history of cerebral palsy, No history of antiepileptic drug consumption. Exclusion criteria: Pseudo- seizures, Skin rash especially Stevens Johnson syndrome, Drug-induced hepatitis, Acute psychosis, Renal disorders, Severe agitation, any other mild side effects that is unbearable to the patient or parents

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Occurence of seizure. Timepoint: Six months from the beginning of study. Method of measurement: Desciption of patients and parents.

Secondary

MeasureTime frame
Rise of liver enzymes. Timepoint: One month after beginning of the study. Method of measurement: Measurment of AST and ALT.;Skin rash. Timepoint: In the six month from the beginning of the study. Method of measurement: Observation.;Agitation. Timepoint: In the six month from the beginning of the study. Method of measurement: Parents report.;Somnolence. Timepoint: In the six month from the beginning of the study. Method of measurement: Parents report.;Advers blood effects. Timepoint: One montn after beginning of study. Method of measurement: CBC examination.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHosein Eslamiyeh

Mashhad University of Medical Sciences

Eslamieh@ssu.ac.ir+98 51 3854 3031

Outcome results

None listed

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