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NCT Number: NCT07490769

Levetiracetam Three Times Daily in Epilepsy

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

King Saud University

Riyadh, Riyadh Region, 13321, Saudi Arabia

Location status: Recruiting

Location contact

Bandar N Aljafen, MD

SUB_INVESTIGATOR

Bandar S Balkhi, PhD

SUB_INVESTIGATOR

Fatimah Alotaibi, MD

SUB_INVESTIGATOR

King Saud University King Saud University

CONTACT

[email protected]

+966114670011

Saeed A Alqahtani, PhD

SUB_INVESTIGATOR

Waad H Alkathiri, PhD Candidate

CONTACT

[email protected]

Waad H Alkathiri, PhD candidate

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levetiracetam

Drug

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. % 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)

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Waad Alkathiri

Other

Registry information

Official study title

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

Acronym: LEVTID

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Mar 24, 2026
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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