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Quality of life and seizure control in patients with brain tumor-related epilepsy treated with levetiracetam monotherapy compared by sodium-valproate monotherapy

Clinical trial on comparison of levetiracetam monotherapy and sodium valproate monotherapy on quality of life and seizure control in patients with brain tumor-related epilepsy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015052022340N1
Enrollment
23
Registered
2015-12-26
Start date
2015-05-31
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

brain tumor related epilepsy. Epilepsy

Interventions

Intervention 1: Intervention group 1: Levetiracetam starting dose is 250 mg BID and it is up titrated (500 mg/week) to 1.000– 3.000 mg/day, depending on seizure control and tolerability. Intervention
Treatment - Drugs
Intervention group 1: Levetiracetam starting dose is 250 mg BID and it is up titrated (500 mg/week) to 1.000– 3.000 mg/day, depending on seizure control and tolerability.
Intervention group 2: Sodium-valproate starting dose is 200 mg BID, and it is up titrate (200 mg/week) to 1000 – 3000 mg/day, depending on seizure control and tolerability.

Sponsors

Vice chancellor for research of Isfahan University of medical sciences
Lead Sponsor
Cobel Darou company
Collaborator

Eligibility

Sex/Gender
All
Age
12 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criteria: Patients with brain tumors and epilepsy characterized by simple or complex partial seizures, with or without secondary generalization; Patients who had at least one seizure prior to having been referred to our center, who had never undergone prior anti-epileptic drug (AED) therapy; Patients who had received previous AED (with a verification that the previous AEDs had been in the therapeutic range but not controlled; Patients with severe side effects with previous AED therapy. Exclusion criteria: Patients with epilepsy prior to tumor onset; Patient with known sever liver disease for Sodium-Valproate group.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Seizure. Timepoint: nomber of seizure attack. Method of measurement: telephon call or visit of patient 0 and 6 month after add patients.;Quality of life. Timepoint: Start of the study and 6 months after the start point. Method of measurement: quality of life in epilepsy inventory (QOLIE-31-P).;Anxiety. Timepoint: Start of the study and 6 months after the start point. Method of measurement: Beck anxiety inventory (BAI).;Depression. Timepoint: Start of the study and 6 months after the start point. Method of measurement: Beck depression inventory (BDI-II).;Cognitive function. Timepoint: Start of the study and 6 months after the start point. Method of measurement: mini-mental state examination (MMSE).;Blood indices. Timepoint: Start of the study and 6 months after the start point. Method of measurement: Taking blood sample and send to laboratory.;Side effects. Timepoint: Monthly. Method of measurement: Interview (in-person and by telephone).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSomayyeh Sadat Teimouri

Isfahan University of Medical Sciences

somayyeh.teimouri@gmail.com+98 313233091

Outcome results

None listed

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