Levetiracetam Three Times Daily in Epilepsy (LEVTID)

March 22, 2026 updated by: Waad Alkathiri

Evaluating Efficacy and Tolerability of Three Times Daily Levetiracetam in Epilepsy Patients

The purpose of this clinical trial is to evaluate the efficacy and tolerability of Levetiracetam administered three times daily in patients with epilepsy. The primary objective is to investigate whether orally administered Levetiracetam three times daily dosing is superior in seizure-free days compared to standard twice-daily dosing in patients with epilepsy.

Key questions include:

  • Does LEV improve seizure control, as measured by seizure-free days?
  • What adverse events or safety concerns are observed with LEV treatment?

Participants will receive Levetiracetam administered three times daily during the treatment phase. The study will use a self-matched, pre-post design in which each participant serves as their own control. Baseline seizure activity and safety data will be collected prior to LEV initiation and compared with data obtained during the treatment period. Participants will attend scheduled clinic visits for efficacy and safety evaluations and will maintain a daily diary to record seizure frequency and any treatment-related events.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
    • Riyadh Region
      • Riyadh, Riyadh Region, Saudi Arabia, 13321
        • Recruiting
        • King Saud university
        • Contact:
        • Contact:
        • Principal Investigator:
          • Waad H Alkathiri, PhD candidate
        • Sub-Investigator:
          • Saeed A Alqahtani, PhD
        • Sub-Investigator:
          • Bandar N Aljafen, MD
        • Sub-Investigator:
          • Bandar S Balkhi, PhD
        • Sub-Investigator:
          • Fatimah Alotaibi, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged 18 years or older.
  • diagnosed with uncontrolled Epilepsy of any type (defined as one or more unprovoked seizures in the last 6 months)
  • On Levetiracetam monotherapy
  • Participants must have a documented history of Levetiracetam use for at least 12 months prior to enrollment.
  • on Levetiracetam high dose (1.5 - 3 g daily)

Exclusion Criteria:

  • Younger than Aged 18 years
  • Received Levetiracetam intravenous within the last 24hr.
  • Co-administered with other antiepileptic drugs
  • Received other antiepileptic drugs in the last two weeks.
  • Pregnant women.
  • Renal impairment (Crcl < 30) or Acute kidney injury

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Levetiracetam BID
Levetiracetam (750mg - 1500 mg) oral tablet twice times a day for 12 months
Drug: Levetiracetam
Levetiracetam oral (500mg - 1000 mg) tablet three times a day for 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in mean number of Seizure-free days
Time Frame: within 6 months pre and post interventions
The mean number of seizure-free days (unit: days), defined as calendar days without any reported seizure events, will be measured and compared in patients with epilepsy during treatment with Levetiracetam administered three times daily versus twice daily (self-controlled comparison). Seizure-free days will be assessed using a patient-reported seizure diary (standardized daily seizure log)
within 6 months pre and post interventions

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
% Adverse events
Time Frame: 12 month post interventions
the percent frequency of Levetiracetam adverse events (agitation, behaviors, psychiatric, dizziness, headache, and other AE reported by participants) between the three times daily versus twice daily of Levetiracetam in patients with epilepsy. Levetiracetam adverse events assessed using a patient-reported seizure diary (standardized daily seizure log)
12 month post interventions

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
mean change in QoL
Time Frame: 6 and 12 months post intervention
The mean change from baseline in quality of life (unit: QOLIE-31 total score, range 0-100) will be measured and compared in patients with epilepsy during treatment with Levetiracetam administered three times daily versus twice daily (self-controlled comparison). Quality of life will be assessed using the Quality of Life in Epilepsy-31 (QOLIE-31) questionnaire, a validated patient-reported outcome measure.
6 and 12 months post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Waad Alkathiri

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2025

Primary Completion (Estimated)

December 30, 2028

Study Completion (Estimated)

December 30, 2028

Study Registration Dates

First Submitted

March 11, 2026

First Submitted That Met QC Criteria

March 22, 2026

First Posted (Actual)

March 24, 2026

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 22, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCTR25011502

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

confidentiality agreement

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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