Phase 3
Completed N=158
A Study to Look at the Efficacy and Safety of Keppra® Extended Release Formulation - XR
Source: ClinicalTrials.gov NCT00368069 ↗Enrolled (actual)
158
Serious AEs
5.1%
Results posted
Jul 2009
Primary outcomePrimary: Partial Onset Seizure (POS) Frequency Per Week - Intention-To-Treat (ITT) Population — 0.912; 1.067 seizures per week (log-transformed data) — p=0.038
Summary
This is a safety and efficacy study of Keppra® extended release formulation - XR in patients with epilepsy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Partial Onset Seizure (POS) Frequency Per Week - Intention-To-Treat (ITT) Population |
0.912; 1.067 | 0.038 sig |
| PRIMARY Partial Onset Seizure (POS) Frequency Per Week - Per Protocol (PP) Population |
0.914; 1.119 | 0.003 sig |
| SECONDARY POS Seizure Frequency Per Week Over Baseline and Treatment Period |
1.80; 2.11; 0.99; 1.36 | — |
| SECONDARY All (Type I+II+III) Seizures Frequency Per Week |
0.928; 1.086 | 0.034 sig |
| SECONDARY 50% Response in Weekly POS Frequency |
34; 23; 45; 56 | 0.070 |
| SECONDARY Response in Weekly POS Frequency (Categorized Into 6 Categories According to Reduction) Over the Treatment Period of 12 Weeks |
11; 13; 14; 23; 35; 34 | 0.033 sig |
Eligibility Criteria
Inclusion Criteria
- Patients with a confirmed diagnosis of refractory epilepsy
- Patients must be receiving a stable dose of 1 - 3 concomitant Anti-Epileptic Drugs (AED)
- Female patients without childbearing potential. Female patients with childbearing potential are eligible if they use a medically accepted non-hormonal contraceptive method
Exclusion Criteria
- Seizures occurring in clusters
- Status epilepticus within 3 months of Visit 1
- History of non-epileptic seizures
- Known allergic reaction or intolerance to pyrrolidine derivatives and/or excipients
- Pregnant or lactating women. Any woman with childbearing potential who is not using a medically accepted, non-hormonal method of birth control
Data sourced from ClinicalTrials.gov (NCT00368069). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.