A Study of Levetiracetam as Monotherapy or Adjunctive Treatment of Partial Seizures in Pediatric … (NCT03340064) | Clinical Trial Compass
CompletedPhase 3
A Study of Levetiracetam as Monotherapy or Adjunctive Treatment of Partial Seizures in Pediatric Epileptic Subjects Ranging From 1 Month to Less Than 4 Years of Age
Japan38 participantsStarted 2017-11-30
Plain-language summary
This is a study to confirm the efficacy of levetiracetam as adjunctive treatment or as monotherapy in pediatric epilepsy subjects aged 1 month to less than 4 years of age with partial seizures.
Who can participate
Age range1 Month – 3 Years
SexALL
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Inclusion Criteria:
* Subject must have a diagnosis of epilepsy with partial onset seizures whether or not secondarily generalized
* Male or female from 1 month to \<4 years of age. Pre-term infants aged \<1 year are to be stratified into an appropriate age category using the best estimate of their corrected gestational age
* For subjects on adjunctive therapy, subject must be on a stable antiepileptic drug (AED) regimen for the Selection and Evaluation Periods of the study. Minor adjustments to the dose of current AEDs are allowed only prior to Visit 1. Monotherapy subjects must not receive AED treatment, receive temporary AED treatment, or switch an AED prior to Visit 1
* Subject weighs \>=3.0 kg
* Subject may have Vagal Nerve Stimulation (VNS) which has been implanted for at least 6 months prior to Visit 1; the settings must be stable for at least 2 months prior to Visit 1. Activated VNS must be counted as 1 of the 2 AEDs
* Subject must have experienced at least 2 observable partial seizures, with or without secondary generalization during each 7-day period during the 2 weeks prior to Visit 1. This time period (the 2 weeks prior to Visit 1) will be referred to as the Retrospective Baseline Period. This seizure information (including type, frequency, and date) must have been recorded on a daily record card (DRC) in order to be acceptable
* If epilepsy surgery has been performed prior to study entry, subjects must have a documented failed epilepsy surgery outcome at least 4…
What they're measuring
1
Percent Change in Partial Seizure Frequency Per Week From Baseline to Visit 6
Timeframe: From Baseline (Week 0) to Visit 6 (up to Week 6)