NCT03340064

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

An Open-Label, Single-Arm, Multicenter 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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: UCB Japan Co. Ltd. · Industry
• Sex: All
• Age: 1 Month – 3 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study will consist of 2 periods. The First Period (6 weeks drug treatment) is designed to confirm efficacy of levetiracetam (LEV), and the Second Period is designed to evaluate the long-term efficacy and safety of LEV.

Conditions

• Partial Seizures

Interventions

Type	Name	Description
DRUG	Levetiracetam	levetiracetam dry syrup 50% for oral administration and levetiracetam solution for infusion (100 mg/mL)

Timeline

• Start date: 2017-11-30
• Primary completion: 2021-06-01
• Completion: 2023-07-28
• First posted: 2017-11-13
• Last updated: 2024-07-23
• Results posted: 2024-07-23

Locations

21 sites across 1 country: Japan