comparison of Tegatard and Tegretol on seizure control

Comparison of the efficacy of Tegatard and Tegretol on complex partial seizure and secondary generalized seizure

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT2017092114217N1

Enrollment

240

Registered

2017-10-17

Start date

2017-10-12

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

Complex partial seizures developing into secondarily generalized seizures. Localization-related (focal)(partial) symptomatic epilepsy and epileptic syndromes with complex partial seizures

Interventions

Intervention 1: 2. Control group: Tegretol 10-20 mg/kg/day in two divided dose. Intervention 2: 1. Intervention group: Tegatard 10-20 mg/kg/day in two divided dose.

Treatment - Drugs

2. Control group: Tegretol 10-20 mg/kg/day in two divided dose

1. Intervention group: Tegatard 10-20 mg/kg/day in two divided dose

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria: patients with diagnosis of complex partial seizure or secondary generalized seizure according to international league against epilepsy; desire to participate in research; Signature of Moral Consent Form Exclusion criteria: Those patients in need of poly therapy; Patients who do not continue treatment for any reason; Seizures that are caused by systemic and metabolic diseases

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Seizure free duration. Timepoint: before intervention, after 3 and 6 month of intervention. Method of measurement: interview.;Frequency of seizure attack. Timepoint: before intervention, after 3 and 6 month of intervention. Method of measurement: interview.;Carbamazepine serum level. Timepoint: After 3 and 6 month of intervention. Method of measurement: Laboratory data.;Severity of seizure attack. Timepoint: After 3 and 6 month of intervention. Method of measurement: Severity of seizure questionnaire.	—

Measure

Time frame

Seizure free duration. Timepoint: before intervention, after 3 and 6 month of intervention. Method of measurement: interview.;Frequency of seizure attack. Timepoint: before intervention, after 3 and 6 month of intervention. Method of measurement: interview.;Carbamazepine serum level. Timepoint: After 3 and 6 month of intervention. Method of measurement: Laboratory data.;Severity of seizure attack. Timepoint: After 3 and 6 month of intervention. Method of measurement: Severity of seizure questionnaire.

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Secondary

Measure	Time frame
Neurological side effects. Timepoint: 3 and 6 month after treatment. Method of measurement: interview.;RBC count. Timepoint: 1 month after treatment. Method of measurement: Laboratory.;WBC count. Timepoint: 1 month after treatment. Method of measurement: Laboratory.;Platelet count. Timepoint: 1 month after treatment. Method of measurement: Laboratory.;Hgb serum level. Timepoint: 1 month after treatment. Method of measurement: Laboratory.;ALT serum level. Timepoint: 1 month after treatment. Method of measurement: Laboratory.;AST serum level. Timepoint: 1 month after treatment. Method of measurement: Laboratory.;ALKP serum level. Timepoint: 1 month after treatment. Method of measurement: Laboratory.;Direct bilirubin serum level. Timepoint: 1 month after treatment. Method of measurement: Laboratory.;Total bilirubin serum level. Timepoint: 1 month after treatment. Method of measurement: Laboratory.;Indirect bilirubin serum level. Timepoint: 1 month after treatment. Method of measurement: Laboratory.	—

Measure

Time frame

Neurological side effects. Timepoint: 3 and 6 month after treatment. Method of measurement: interview.;RBC count. Timepoint: 1 month after treatment. Method of measurement: Laboratory.;WBC count. Timepoint: 1 month after treatment. Method of measurement: Laboratory.;Platelet count. Timepoint: 1 month after treatment. Method of measurement: Laboratory.;Hgb serum level. Timepoint: 1 month after treatment. Method of measurement: Laboratory.;ALT serum level. Timepoint: 1 month after treatment. Method of measurement: Laboratory.;AST serum level. Timepoint: 1 month after treatment. Method of measurement: Laboratory.;ALKP serum level. Timepoint: 1 month after treatment. Method of measurement: Laboratory.;Direct bilirubin serum level. Timepoint: 1 month after treatment. Method of measurement: Laboratory.;Total bilirubin serum level. Timepoint: 1 month after treatment. Method of measurement: Laboratory.;Indirect bilirubin serum level. Timepoint: 1 month after treatment. Method of measurement: Laboratory.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Mohammad Reza Najafi

Isfahan University of Medical Sciences

najafi@med.mui.ac.ir; mreznaj@gmail.com+98 31 3627 3910

Outcome results

None listed

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