Generic Substitution of Original Levetiracetam in Thai Epilepsy Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Epilepsy
• Intervention / Treatment: Drug: Generic levetiracetam

• Study Type: Observational
• Enrollment (Actual): 75

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10400
    • Prasat Neurological Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Any epileptic patients who received generic substitution to original levetiracetam from February 2016 to May 2018

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Generic levetiracetam	Drug: Generic levetiracetam; Generic levetiracetam tablet as the same dose as original levetiracetam tablet at the switching date

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Jannapas Tharavichitkun, Mahidol University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): May 30, 2019
• Study Completion (Actual): May 30, 2019

Study Registration Dates

• First Submitted: October 15, 2019
• First Submitted That Met QC Criteria: October 16, 2019
• First Posted (Actual): October 18, 2019

Study Record Updates

• Last Update Posted (Actual): October 18, 2019
• Last Update Submitted That Met QC Criteria: October 16, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Epilepsy; Generic; Levetiracetam; Therapeutic equivalency
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Anticonvulsants; Nootropic Agents; Levetiracetam
• Other Study ID Numbers: 2018/PY119

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No