At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 31 enrolled
Drug / intervention
Seletracetam (ucb 44212)drug
Likely dose
Seletracetam 10–80 mg orally twice daily (total daily dose 20–160 mg)AI-extracted
Key inclusion· 3
- ✓Age 18–65 years, minimum body weight 40 kg
- ✓Confirmed diagnosis of epilepsy with partial onset seizures (with or without secondary generalization)
- ✓Refractory epilepsy: uncontrolled seizures despite treatment for ≥6 months with 1–3 concomitant AEDs
Key exclusion· 10
- ✕Seizures occurring in clusters
- ✕Status epilepticus within 6 months before study entry
- ✕History of non-epileptic seizures
- ✕Current treatment with levetiracetam
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label, Exploratory, Multicenter, Dose-escalation Study Examining the Efficacy, Safety and Tolerability of Ucb 44212 Used at Doses of 10 mg, 20 mg, 40 mg and 80 mg b.i.d. (Total Daily Dose of 20 to 160 mg) in Adult Subjects (18-65 Years) With Refractory Epilepsy Suffering From Partial Onset Seizures (Whether or Not Secondarily Generalized) and Treated With 1, 2 or 3 Approved Antiepileptic Drugs
In Brief
A Phase 2 clinical trial evaluating Seletracetam (ucb 44212) for Epilepsy, Partial. Completed, enrolled 31 participants across 7 sites.
Detailed Summary
This trial will evaluate the efficacy and safety of ucb 44212 as add on therapy in subjects with focal epilepsy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy, Partial
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2005
First PostedSep 2005
Primary CompletionMay 2006
TodayJul 2026
First PostedSep 9, 2005
Enrollment StartMay 19, 2005
Primary CompletionMay 3, 2006
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 20.8 years ago
Interventions
Seletracetam (ucb 44212)drug
* Pharmaceutical form: oral capsules * Concentration: 10 and 50 mg * Route of administration: oral administration