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Related Experiment Videos

The SKATE study: interim analysis.

Glynn Owen Olwen

    International Journal of Clinical Practice
    |August 16, 2003
    PubMed
    Summary

    The Safety of Keppra as Adjunctive Therapy in Epilepsy (SKATE) study found levetiracetam (Keppra) significantly reduced seizure frequency in adults with uncontrolled partial seizures. Many patients experienced substantial seizure reduction or complete seizure freedom with good tolerability.

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    Area of Science:

    • Neurology
    • Clinical Pharmacology
    • Epilepsy Research

    Background:

    • Epilepsy affects millions globally, with many patients experiencing uncontrolled seizures despite current treatments.
    • Partial seizures are a common type of epilepsy, often requiring adjunctive therapy for effective management.
    • Levetiracetam (Keppra) is an established antiepileptic drug used in epilepsy treatment.

    Purpose of the Study:

    • To evaluate the safety and efficacy of levetiracetam (Keppra) as adjunctive therapy in adult patients with uncontrolled partial seizures.
    • To assess seizure frequency reduction and seizure freedom rates in a large, international patient cohort.
    • To monitor adverse events and tolerability of levetiracetam in a real-world clinical setting.

    Main Methods:

    • Phase IV, open-label, international study (SKATE) involving 1400 adult patients with uncontrolled partial seizures.
    • Interim analysis of 731 patients from 117 centers across nine countries over a 16-week treatment period.
    • Data collection on seizure frequency, seizure freedom, and adverse events associated with levetiracetam adjunctive therapy.

    Main Results:

    • An interim analysis demonstrated a significant reduction in seizure frequency, with 49% of patients experiencing a 50% or greater reduction.
    • A notable 17.2% of patients achieved complete seizure freedom during the study period.
    • Levetiracetam was generally well-tolerated, with adverse events being predominantly mild to moderate and rarely necessitating treatment discontinuation.

    Conclusions:

    • Levetiracetam (Keppra) is an effective and well-tolerated adjunctive therapy for adult patients with uncontrolled partial seizures.
    • The study supports the use of levetiracetam in achieving substantial seizure control, including complete seizure freedom, in a significant proportion of patients.
    • The findings from the SKATE study contribute valuable real-world evidence on the safety and efficacy profile of levetiracetam in epilepsy management.

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