Evaluation of Levetiracetam's Effectiveness and Tolerability for Treating Epilepsy in Older Adults (LEVEL)

Investigation of Efficacy and Tolerability of Levetiracetam for Epilepsy in Elderly

This prospective interventional study was conducted between 2023 and 2025 at the Department of Neurology of Bouali Sina Hospital. Consecutive elderly patients presenting with epilepsy were screened for eligibility. The diagnosis of epilepsy was confirmed by the treating neurologist. The patients underwent treatment with levetiracetam. Primary and secondary outcomes were investigated as was explained before.

Study Overview

• Status: Completed
• Conditions: Epilepsy; Elderly
• Intervention / Treatment: Drug: Oral levetiracetam

• Study Type: Interventional
• Enrollment (Actual): 137
• Phase: Phase 4

Contacts and Locations

Study Locations

• Iran
  • Mazandaran
    • Sari, Mazandaran, Iran, 4815733971
      • Mazandaran University of medical sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥60 years
2. Diagnosis of epilepsy

Exclusion Criteria:

1. Chronic kidney disease requiring dialysis
2. History of psychotic disorders or current use of anxiolytic, antidepressant, or antipsychotic medications
3. Current use of antiseizure medications for any reason

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Levetiracetam; Elderly patients with epilepsy who have received levetiracetam	Drug: Oral levetiracetam; Treatment with levetiracetam tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seizure free rate	The rate of patients who stayed seizure-free after drug initiation	12 months
Retention rate	The rate of patients who continue taking drug	12 months
Time to first seizure	The interval between starting drug and recurrence of seizure	at occurrence of first seizure
Time to withdrawal	The interval between starting drug and stoping its use	the day that the patient stops taking drug

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerability rate	the rate of patients that forfeit participation in the study due to adverse effects	12 months

Collaborators and Investigators

• Sponsor: Nasim Tabrizi

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2023
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): January 20, 2026

Study Registration Dates

• First Submitted: February 5, 2026
• First Submitted That Met QC Criteria: February 12, 2026
• First Posted (Actual): February 19, 2026

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acids, Acyclic; Carboxylic Acids; Amides; Pyrrolidines; Acetamides; Acetates; Pyrrolidinones; Levetiracetam
• Other Study ID Numbers: 11402 (Stanford IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: If requested in certain circumstances.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No