Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levetiracetam BID | Active Comparator | Levetiracetam (750mg - 1500 mg) oral tablet twice times a day for 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levetiracetam | Drug | Levetiracetam oral (500mg - 1000 mg) tablet three times a day for 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| % Adverse events | 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) | 12 month post interventions |
| Measure | Description | Time Frame |
|---|---|---|
| mean change in QoL | The mean change from baseline in quality of life (unit: QOLIE-31 total score, range 0-100) will be measured and compared in patients with epilepsy during treatment with Levetiracetam administered three times daily versus twice daily (self-controlled comparison). Quality of life will be assessed using the Quality of Life in Epilepsy-31 (QOLIE-31) questionnaire, a validated patient-reported outcome measure. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Saud University | Recruiting | Riyadh | Riyadh Region | 13321 | Saudi Arabia |
confidentiality agreement
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077287 | Levetiracetam |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 6 and 12 months post intervention |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |