CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 223 enrolled
Drug / intervention
Levetiracetamdrug
Likely dose
Not stated in record
Key inclusion· 2
  • ✓Completion of prior levetiracetam pediatric trial (Study N151 or other applicable trial)
  • ✓Investigator and patient/parent agreement that levetiracetam treatment would be of potential benefit
Key exclusion· 2
  • ✕Patient cannot be on a ketogenic diet during the study
  • ✕Seizures must be countable; exclusion if seizures too close together to accurately count

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

Search/NCT00150709
NCT00150709Phase 3Completed
CompareCT.gov

A Multi-Center, Open-Label, Long-Term, Follow-Up Study Of The Safety And Efficacy Of Levetiracetam (Ucb L059) In Children With Epilepsy

UCB Pharma·interventional·Posted Sep 8, 2005·Updated Feb 9, 2024

In Brief

A Phase 3 clinical trial evaluating Levetiracetam for Epilepsy, Partial. Completed, enrolled 223 participants.

Detailed Summary

Open-label study to allow pediatric patients who have participated in prior Levetiracetam (Keppra®) studies to continue their treatment with adequate monitoring and standardized follow-up care until Levetiracetam (Keppra®) is approved for use in children or until the completion of the development program for pediatrics.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy, Partial
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 8, 2005
Enrollment StartJan 26, 1998
Primary CompletionJan 25, 2006
TodayJul 2, 2026
Enrollment to primary: 8.0 yearsPosted 20.8 years ago

Interventions

Levetiracetamdrug

* Pharmaceutical form: Oral tablets and oral solution * Route of administration: Oral use