CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 66 enrolled
Drug / intervention
Levetiracetamdrug
Likely dose
Levetiracetam 500 mg orally twice daily (b.i.d.), individualized to 1000–3000 mg/day totalAI-extracted
Key inclusion· 4
  • ✓Confirmed diagnosis of epilepsy
  • ✓History of unprovoked partial seizures (IA, IB, IC with clear focal origin) or generalized tonic-clonic seizures (without clear focal origin), classifiable per International Classification of Epileptic Seizures
  • ✓Completion of prior double-blind monotherapy trial N01061 (NCT00150735) or N01093 (NCT00150787)
  • ✓Age ≥16 years
Key exclusion· 1
  • ✕Need for an additional antiepileptic drug (AED)

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

Search/NCT00150813
NCT00150813Phase 3Completed
CompareCT.gov

A Multicenter, Open-label, Follow-up Trial Evaluating the Long-term Safety of Levetiracetam Individualized Dose From 1000 to 3000 mg/Day (Oral Tablets of 500 mg b.i.d.), Used as Monotherapy in Subjects (≥ 16 Years) Suffering From Epilepsy and Coming From the N01061 or the N01093 Trials.

UCB Pharma SA·interventional·Posted Sep 8, 2005·Updated Nov 21, 2018

In Brief

A Phase 3 clinical trial evaluating Levetiracetam for Epilepsy, Tonic-clonic. Completed, enrolled 66 participants across 21 sites in 4 countries.

Detailed Summary

An open-label follow-up trial assessing the long term safety of levetiracetam as per adverse events reporting.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy, Tonic-clonic
CountriesCzechia, Hungary, Poland, Sweden
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 8, 2005
Enrollment StartAug 10, 2005
Primary CompletionMay 29, 2007
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 20.8 years ago

Interventions

Levetiracetamdrug

Pharmaceutical form: oral tablets Route of administration: Oral use