Generic Substitution of Original Levetiracetam in Thai Epilepsy Patients

NCT ID: NCT04132063

Last Updated: 2019-10-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 75 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2019-05-30

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.

Conditions

Epilepsy

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

Generic levetiracetam

Generic levetiracetam

Intervention Type: DRUG

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

Interventions

Generic levetiracetam

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

Intervention Type: DRUG

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jannapas Tharavichitkun

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

Prasat Neurological Institute

Bangkok, , Thailand

Countries

Thailand

Other Identifiers

2018/PY119

Identifier Type: -

Identifier Source: org_study_id