CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 255 enrolled
Drug / intervention
levetiracetam (LEV)drug
Likely dose
Levetiracetam 10 to 30 mg/kg/day orally twice daily for 48 weeks (or approximately 52 weeks if discontinuation occurs at end of maintenance period)AI-extracted
Key inclusion· 3
  • ✓Pediatric patients with partial onset seizures
  • ✓Currently on 1 to 2 anti-epileptic drugs (AEDs)
  • ✓Prior participation in levetiracetam pediatric studies N01009 or N01103, or direct enrollment
Key exclusion· 5
  • ✕Patients on a ketogenic diet
  • ✕Seizures too close together to accurately count
  • ✕Pseudoseizures
  • ✕Status epilepticus within 1 month prior to Visit 1

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00152516
NCT00152516Phase 3Completed
CompareCT.gov

A Multi-Center, Open-Label, Long-Term, Follow-Up Study Of the Safety And Efficacy Of Levetiracetam In Children With Partial Onset Seizures.

UCB Pharma·interventional·Posted Sep 9, 2005·Updated Feb 12, 2013

In Brief

A Phase 3 clinical trial evaluating levetiracetam (LEV) for Epilepsy, Partial. Completed, enrolled 255 participants across 84 sites in 16 countries.

Detailed Summary

To allow pediatric patients with partial onset seizures an opportunity to receive (as follow-up to studies N01009(NCT00105040)/N01103(NCT00175890) or by direct enrollment) open-label levetiracetam treatment, continue studying cognition and behavior in children, and continue collection of safety/efficacy data.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy, Partial
CountriesBelgium, Brazil, Canada, Czechia, France, Germany, Hungary, India, Italy, Mexico, Poland, Romania, Russia, South Africa, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 9, 2005
Enrollment StartOct 1, 2004
Primary CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 20.8 years ago

Interventions

levetiracetam (LEV)drug

Per protocol oral tablets or oral solution at 10 to 30mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.