CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 59 enrolled
Drug / intervention
Seletracetam (UCB44212)drug
Likely dose
Seletracetam 10-80 mg orally twice daily (total daily doses 20-160 mg)AI-extracted
Key inclusion· 4
  • ✓Age 18-65 years with minimum body weight 40 kg
  • ✓Confirmed diagnosis of epilepsy with partial onset seizures (with or without secondary generalization)
  • ✓Treated for epilepsy ≥6 months and uncontrolled on current therapy
  • ✓Currently receiving levetiracetam (LEV) as one of 1-3 concomitant AEDs
Key exclusion· 8
  • ✕Seizures occurring in clusters or status epilepticus within 6 months
  • ✕History of non-epileptic seizures
  • ✕Current use of vigabatrin
  • ✕Use of felbamate unless continuous for >2 years

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

Search/NCT00152503
NCT00152503Phase 2Completed
CompareCT.gov

An Open Label, Exploratory, Dose-escalation, Multicenter Study Examining the Safety, Tolerability and Efficacy of Ucb 44212 (Seletracetam) Used at Doses of 10, 20, 40, and 80 mg b.i.d. (Total Daily Doses of 20 - 160 mg) Administration (Oral Capsules) in Adult Subjects (18 - 65 Years) With Refractory Epilepsy Suffering From Partial Onset Seizures Who Are Currently Receiving Levetiracetam (LEV) But Still Experiencing Seizures

UCB Pharma SA·interventional·Posted Sep 9, 2005·Updated Sep 7, 2023

In Brief

A Phase 2 clinical trial evaluating Seletracetam (UCB44212) for Epilepsy, Partial. Completed, enrolled 59 participants across 17 sites in 2 countries.

Detailed Summary

This trial will evaluate the efficacy and safety of UCB44212 as add-on therapy in subjects with focal epilepsy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy, Partial
CountriesCanada, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 9, 2005
Enrollment StartAug 31, 2005
Primary CompletionMay 12, 2006
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 20.8 years ago

Interventions

Seletracetam (UCB44212)drug

* Pharmaceutical form: oral capsules * Concentration: 2, 10 and 50 mg * Route of administration: oral administration