Generic Substitution of Original Levetiracetam in Thai Epilepsy Patients

Completed

• Conditions: Epilepsy
• Interventions: Drug: Generic levetiracetam

• Registration Number: NCT04132063
• Lead Sponsor: Mahidol University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-01
• Primary Completion: 2019-05-30
• Study Completion: 2019-05-30
• Status Verified: 2019-10
• Study First Submitted: 2019-10-15
• Study First Submitted QC: 2019-10-16
• Last Update Submitted: 2019-10-16
• Study First Posted: 2019-10-18
• Last Update Posted: 2019-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Generic levetiracetam	Generic levetiracetam	-

Primary Outcome Measures

Name	Time	Method
Change from baseline seizure frequency	At baseline, 3 and 6 months after generic levetiracetam substitution	Change from baseline seizure frequency per month at 3 and 6 months

Secondary Outcome Measures

Name	Time	Method
Composite outcomes	During 6 months of generic levetiracetam substitution	Incidence of composite outcomes related to dosage adjustment of antiepileptic drugs such as; 1. Switching back to original levetiracetam due to experiencing an uncontrolled seizure or adverse drug reactions,; 2. The incremental dose of generic levetiracetam due to experiencing an uncontrolled seizure,; 3. The decremental dose of generic levetiracetam due to experiencing adverse events,; 4. Add-on other antiepileptic drugs due to experiencing an uncontrolled seizure,; 5. The incremental dose of concurrent antiepileptic drugs due to experiencing an uncontrolled seizure.
Hospitalization	During 6 months of generic levetiracetam substitution	Incidence of hospitalization due to breakthrough seizure
Adverse events	During 6 months of generic levetiracetam substitution	Incidence of adverse events after generic levetiracetam substitution

Trial Locations

Locations (1)

Prasat Neurological Institute; 🇹🇭 Bangkok, Thailand