Generic Substitution of Original Levetiracetam in Thai Epilepsy Patients

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04132063
• Other study ID #: 2018/PY119
• Status: Completed
• Start date: November 1, 2018
• Est. completion date: May 30, 2019

Study information

• Verified date: October 2019
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: May 30, 2019
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• Generic levetiracetam
Generic levetiracetam tablet as the same dose as original levetiracetam tablet at the switching date

Locations

Country	Name	City	State
Thailand	Prasat Neurological Institute	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Hospitalization	Incidence of hospitalization due to breakthrough seizure	During 6 months of generic levetiracetam substitution
Secondary	Adverse events	Incidence of adverse events after generic levetiracetam substitution	During 6 months of generic levetiracetam substitution
Secondary	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