Generic Substitution of Original Levetiracetam in Thai Epilepsy Patients

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy and Safety of Generic Substitution of Original Levetiracetam in Patients With Epilepsy

Conditions
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Epilepsy

Intervention / Treatment
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* Drug: Generic levetiracetam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of epilepsy for at least 6 months prior to generic levetiracetam substitution; Same dosage form and strength of generic substitution to original levetiracetam; Stable dose of original levetiracetam and stable seizure frequency prior to generic levetiracetam substitution; Stable dose of generic levetiracetam after generic levetiracetam substitution Exclusion Criteria: Absence seizure with levetiracetam monotherapy; Original levetiracetam in dosage form of oral solution or intravenous solution prior to generic levetiracetam substitution; Poor compliance; Death or loss of follow up; Unavailable data for evaluation of outcomes
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Generic levetiracetam<br> | Drug: Generic levetiracetam<br>* Generic levetiracetam tablet as the same dose as original levetiracetam tablet at the switching date<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | During 6 months of generic levetiracetam substitution | 
| Composite outcomes | Incidence of composite outcomes related to dosage adjustment of antiepileptic drugs such as Switching back to original levetiracetam due to experiencing an uncontrolled seizure or adverse drug reactions, The incremental dose of generic levetiracetam due to experiencing an uncontrolled seizure, The decremental dose of generic levetiracetam due to experiencing adverse events, Add-on other antiepileptic drugs due to experiencing an uncontrolled seizure, The incremental dose of concurrent antiepileptic drugs due to experiencing an uncontrolled seizure. | During 6 months of generic levetiracetam substitution | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epilepsy, Generic, Levetiracetam, Therapeutic equivalency