RecruitingPhase 3NCT07490769

Levetiracetam Three Times Daily in Epilepsy

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


Sponsor

Waad Alkathiri

Enrollment

120 participants

Start Date

Oct 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria6

  • 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

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Interventions

DRUGLevetiracetam

Levetiracetam oral (500mg - 1000 mg) tablet three times a day for 12 months


Locations(1)

King Saud University

Riyadh, Riyadh Region, Saudi Arabia

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NCT07490769


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