Phase 3 N=38 Treatment

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

Partial Seizures

Bottom Line

View on ClinicalTrials.gov: NCT03340064 ↗

Enrolled (actual)

Serious AEs

52.6%

Results posted

Jul 2024

Primary outcome: Primary: Percent Change in Partial Seizure Frequency Per Week From Baseline to Visit 6 — 24.24 percent change

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Levetiracetam (Drug)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: UCB Japan Co. Ltd.
Primary completion: Jun 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change in Partial Seizure Frequency Per Week From Baseline to Visit 6	24.24	—
SECONDARY Percent Change in Partial Seizure Frequency Per Week From Baseline to Visit 4	8.62	—
SECONDARY Percent Change in Partial Seizure Frequency Per Week From Baseline to Visit 5	16.79	—
SECONDARY Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Adjunctive Therapy	35.53; 59.39; 50.90; 60.29; 82.74; 80.33	—
SECONDARY Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy	43.8; 18.8; 9.4; 28.1; 12.5; 9.4	—
SECONDARY Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Monotherapy	-51.87; 4.88; 51.10; 100.00; 100.00; 76.92	—
SECONDARY Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy	60.0; 0; 20.0; 40.0; 20.0; 20.0	—
SECONDARY Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the First Period	62.5; 0	—
SECONDARY Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the First Period	9.4; 0	—
SECONDARY Percentage of Participants With TEAEs Leading to Discontinuation From Study Medication During the First Period	6.3; 0	—
SECONDARY Percentage of Participants With TEAEs During the Combined First and Second Period	96.9; 100	—
SECONDARY Percentage of Participants With Treatment-emergent SAEs During the Combined First and Second Period	56.3; 33.3	—
SECONDARY Percentage of Participants With TEAEs Leading to Discontinuation From Study Medication During the Combined First and Second Period	9.4; 16.7	—

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.

Eligibility Criteria

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 =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 weeks prior to Visit 1
The use of intermittent benzodiazepines, phenobarbitals, and phenytoins is allowed as long as the frequency is not greater than 1 single administration per week for at least 2 weeks prior to Visit 1 and throughout study participation. If benzodiazepines are used more than once a week, they must be considered as 1 of the AEDs

Exclusion Criteria

Subject has been taking any medication (other than their concomitant AEDs) that influences the central nervous system (CNS) for which they had not been on a stable regimen for at least 1 month prior to Visit 1
Subject is taking any medication that may interfere with the absorption, distribution, metabolism, or excretion of the concomitant AEDs or levetiracetam (LEV) during the course of the study
Subject has received any investigational medication or device within 30 days prior to Visit 1
Subject has taken LEV prior to the study
Subjects using felbamate who have presented with clinically significant abnormalities and/or hepatic function during felbamate treatment, and subjects who are taking felbamate ULN total bilirubin (≥1.5xULN total bilirubin if known Gilbert's syndrome). If subject has elevations only in total bilirubin that are >ULN and <1.5xULN, fractionate bilirubin to identify possible undiagnosed Gilbert's syndrome (ie, direct bilirubin <35%)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03340064). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.