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Completed

NCT Number: NCT04132063

Generic Substitution of Original Levetiracetam in Thai Epilepsy Patients

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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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Prasat Neurological Institute

Bangkok, 10400, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Generic levetiracetam

Drug

Generic levetiracetam tablet as the same dose as original levetiracetam tablet at the switching date

Primary outcomes

  1. Change from baseline seizure frequency

    Time frame: At baseline, 3 and 6 months after generic levetiracetam substitution

    Change from baseline seizure frequency per month at 3 and 6 months

Secondary outcomes

  1. Hospitalization

    Time frame: During 6 months of generic levetiracetam substitution

    Incidence of hospitalization due to breakthrough seizure

  2. Adverse events

    Time frame: During 6 months of generic levetiracetam substitution

    Incidence of adverse events after generic levetiracetam substitution

  3. Composite outcomes

    Time frame: During 6 months of generic levetiracetam substitution

    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.

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 18, 2019
Registry last updated
Oct 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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