Status:
COMPLETED
Generic Substitution of Original Levetiracetam in Thai Epilepsy Patients
Lead Sponsor:
Mahidol University
Conditions:
Epilepsy
Eligibility:
All Genders
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 le...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 30 2019
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT04132063
Start Date
November 1 2018
End Date
May 30 2019
Last Update
October 18 2019
Active Locations (1)
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1
Prasat Neurological Institute
Bangkok, Thailand, 10400