NCT07490769 Levetiracetam Three Times Daily in Epilepsy
| NCT ID | NCT07490769 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Waad Alkathiri |
| Condition | Epilepsy |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2028-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 120 participants in total. It began in 2025-10-01 with a primary completion date of 2028-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Frequently Asked Questions
Who can join the NCT07490769 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Epilepsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07490769 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 120 participants.
Is NCT07490769 currently recruiting?
Yes, NCT07490769 is actively recruiting participants. Visit ClinicalTrials.gov or contact Waad Alkathiri to inquire about joining.
Where is the NCT07490769 trial being conducted?
This trial is being conducted at Riyadh, Saudi Arabia.
Who is sponsoring the NCT07490769 clinical trial?
NCT07490769 is sponsored by Waad Alkathiri. The trial plans to enroll 120 participants.
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