Epilepsy
Conditions
Keywords
Levetiracetam, TID, Epilepsy
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.
Interventions
DRUGLevetiracetam
Levetiracetam oral (500mg - 1000 mg) tablet three times a day for 12 months
Sponsors
Waad Alkathiri
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in mean number of Seizure-free days | 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
| Measure | Time frame | Description |
|---|---|---|
| % Adverse events | 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) |
Countries
Saudi Arabia
Outcome results
None listed