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The retrospective pre-post observational study was conducted to evaluate the real-world evidence of efficacy and tolerability of generic levetiracetam (oral tablet) which was switched from original levetiracetam (oral tablet) in patients with epilepsy at the national hospital for neurology and neurosurgery in Thailand. Epilepsy patients who received generic substitution to original levetiracetam at the same dose and had stable conditions of seizure were only included. In the period of 6 months, the investigators assessed the change of seizure frequency, the incidence of hospitalization due to breakthrough seizure, the incidence of adverse events and the incidence of composite outcomes related to dosage adjustment of antiepileptic drugs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Generic levetiracetam |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Generic levetiracetam | Drug | Generic levetiracetam tablet as the same dose as original levetiracetam tablet at the switching date |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline seizure frequency | Change from baseline seizure frequency per month at 3 and 6 months | At baseline, 3 and 6 months after generic levetiracetam substitution |
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalization | Incidence of hospitalization due to breakthrough seizure | During 6 months of generic levetiracetam substitution |
| Adverse events | Incidence of adverse events after generic levetiracetam substitution |
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Inclusion Criteria:
Exclusion Criteria:
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Any epileptic patients who received generic substitution to original levetiracetam from February 2016 to May 2018
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| Name | Affiliation | Role |
|---|---|---|
| Jannapas Tharavichitkun | Mahidol University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prasat Neurological Institute | Bangkok | 10400 | Thailand |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| During 6 months of generic levetiracetam substitution |
| Composite outcomes | Incidence of composite outcomes related to dosage adjustment of antiepileptic drugs such as
| During 6 months of generic levetiracetam substitution |