Levetiracetam Three Times Daily in Epilepsy

NCT07490769 | Recruiting Phase 3 DMC

• 1 other identifier: SCTR25011502
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Epilepsy

Keywords

Levetiracetam; TID; Epilepsy

Outcome Measures

Primary Outcomes (1)

• change in mean number of Seizure-free days

  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 Outcomes (1)

• % Adverse events

  12 month post interventions

Other Outcomes (1)

• mean change in QoL

  6 and 12 months post intervention

Study Arms (1)

Levetiracetam BID

ACTIVE COMPARATOR

Levetiracetam (750mg - 1500 mg) oral tablet twice times a day for 12 months

Drug: Levetiracetam

Interventions

Levetiracetam DRUG

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

Levetiracetam BID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Waad Alkathiri: lead

Study Sites (1)

King Saud University

Riyadh, Riyadh Region, 13321, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Epilepsy

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Pharmacist

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 24, 2026
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

SA (1)