Levetiracetam Three Times Daily in Epilepsy

Sponsor
Waad Alkathiri
Study ID
NCT07490769
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Mar 24, 2026
Start date
Oct 1, 2025
Status verified
Mar 2026
Primary completion
Dec 30, 2028
Completion
Dec 30, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Active Comparator: Levetiracetam BID
    Levetiracetam (750mg - 1500 mg) oral tablet twice times a day for 12 months

Primary Outcome Measure

change in mean number of Seizure-free days [ Time Frame: within 6 months pre and post interventions ]

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