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Generic Substitution of Original Levetiracetam in Thai Epilepsy Patients

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ClinicalTrials.gov Identifier: NCT04132063
Recruitment Status : Completed
First Posted : October 18, 2019
Last Update Posted : October 18, 2019
Sponsor:
Information provided by (Responsible Party):
Mahidol University

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.

Condition or disease Intervention/treatment
Epilepsy Drug: Generic levetiracetam

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Study Type : Observational
Actual Enrollment : 75 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Efficacy and Safety of Generic Substitution of Original Levetiracetam in Patients With Epilepsy
Actual Study Start Date : November 1, 2018
Actual Primary Completion Date : May 30, 2019
Actual Study Completion Date : May 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures

Group/Cohort Intervention/treatment
Generic levetiracetam Drug: Generic levetiracetam
Generic levetiracetam tablet as the same dose as original levetiracetam tablet at the switching date




Primary Outcome Measures :
  1. Change from baseline seizure frequency [ Time Frame: At baseline, 3 and 6 months after generic levetiracetam substitution ]
    Change from baseline seizure frequency per month at 3 and 6 months


Secondary Outcome Measures :
  1. Hospitalization [ Time Frame: During 6 months of generic levetiracetam substitution ]
    Incidence of hospitalization due to breakthrough seizure

  2. Adverse events [ Time Frame: During 6 months of generic levetiracetam substitution ]
    Incidence of adverse events after generic levetiracetam substitution

  3. Composite outcomes [ Time Frame: During 6 months of generic levetiracetam substitution ]

    Incidence of composite outcomes related to dosage adjustment of antiepileptic drugs such as

    1. Switching back to original levetiracetam due to experiencing an uncontrolled seizure or adverse drug reactions,
    2. The incremental dose of generic levetiracetam due to experiencing an uncontrolled seizure,
    3. The decremental dose of generic levetiracetam due to experiencing adverse events,
    4. Add-on other antiepileptic drugs due to experiencing an uncontrolled seizure,
    5. The incremental dose of concurrent antiepileptic drugs due to experiencing an uncontrolled seizure.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any epileptic patients who received generic substitution to original levetiracetam from February 2016 to May 2018
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04132063


Locations
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Thailand
Prasat Neurological Institute
Bangkok, Thailand, 10400
Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: Jannapas Tharavichitkun Mahidol University

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Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT04132063    
Other Study ID Numbers: 2018/PY119
First Posted: October 18, 2019    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mahidol University:
Epilepsy
Generic
Levetiracetam
Therapeutic equivalency
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Levetiracetam
Anticonvulsants
Nootropic Agents