NCT04132063

Generic Substitution of Original Levetiracetam in Thai Epilepsy Patients

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 75 (actual)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Generic levetiracetam	Generic levetiracetam tablet as the same dose as original levetiracetam tablet at the switching date

Timeline

• Start date: 2018-11-01
• Primary completion: 2019-05-30
• Completion: 2019-05-30
• First posted: 2019-10-18
• Last updated: 2019-10-18

Locations

1 site across 1 country: Thailand

Regulatory

• FDA-regulated drug study