Levetiracetam taken three times daily for adults with epilepsy
Official title: Evaluating Efficacy and Tolerability of Three Times Daily Levetiracetam in Epilepsy Patients
Run by King Saud University · NCT07490769 · Data updated 2026-11-12
This study will try giving levetiracetam three times a day to adults with uncontrolled epilepsy who are already on high-dose levetiracetam to see if it increases seizure-free days compared with twice-daily dosing.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | King Saud University Academic / other |
| Locations | 1 site (Riyadh, Riyadh Region) |
| Status | Recruiting |
| Started | October 1, 2025 |
| Main results expected | December 30, 2028 |
| Study ends | December 30, 2028 |
| Registry record updated | March 24, 2026 |
| Trial ID | NCT07490769 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with uncontrolled epilepsy who have been on levetiracetam monotherapy at high dose (1.5–3 g/day) for at least 12 months and have had one or more unprovoked seizures in the past 6 months.
✕Probably not a fit
People who are pregnant, have significant renal impairment (CrCl <30 mL/min), are taking other antiepileptic drugs, or already have well-controlled seizures are unlikely to be eligible or to gain benefit from this dosing change.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a phase 3, interventional self-matched pre-post study in which each participant serves as their own control. Adults on levetiracetam monotherapy at high dose (1.5–3 g/day) with at least 12 months of documented use will have baseline seizure and safety data collected, then switch to three-times-daily oral dosing during the treatment period. Participants will keep a daily seizure diary and attend scheduled clinic visits for efficacy and safety monitoring. The primary outcome is change in seizure-free days, and adverse events and renal safety will also be recorded.
Why it matters
Potential benefit: If successful, switching to three-times-daily dosing could increase seizure-free days and improve seizure control without adding other antiepileptic drugs.
How similar studies have gone: Most prior levetiracetam research uses twice-daily dosing and there is limited evidence that thrice-daily dosing is superior, so this dosing strategy is relatively untested in controlled settings.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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King Saud University
Riyadh, Riyadh Region, Saudi Arabia Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.