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Generic Substitution of Original Levetiracetam in Thai Epilepsy Patients

NCT04132063 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 75

Last updated 2019-10-18

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Generic levetiracetam

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

Sponsors & Collaborators

  • Mahidol University

    lead OTHER

Principal Investigators

  • Jannapas Tharavichitkun · Mahidol University

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2019-05-30
Completion
2019-05-30
FDA Drug
Yes

Countries

  • Thailand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04132063 on ClinicalTrials.gov