Phase 3
Completed N=228
Conversion to Monotherapy Study With Keppra XR for Partial Seizures
Source: ClinicalTrials.gov NCT00419094 ↗Enrolled (actual)
228
Serious AEs
6.1%
Results posted
Dec 2010
Primary outcomePrimary: The Cumulative Exit Rate at 112 Days After the Beginning of the Previous Antiepileptic Drug (AED) Tapering Phase — 0.375 proportion of subjects
Summary
The primary objective of this study is to assess the efficacy of two doses of Keppra XR compared with a historical control as the placebo, in the monotherapy treatment of partial onset seizures.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Cumulative Exit Rate at 112 Days After the Beginning of the Previous Antiepileptic Drug (AED) Tapering Phase |
0.375 | — |
| SECONDARY The Cumulative Rate of Exit Events, Which Include Discontinuation Due to Exit Criteria, Withdrawal Due to Adverse Events (AE) and Withdrawal Due to Lack of Efficacy, at 112 Days After the Beginning of Previous Antiepileptic Drug (AED) Tapering Phase |
0.385 | — |
| SECONDARY The Cumulative Rate of Exit Events Due to Any Reasons at 112 Days After the Beginning of Previous Antiepileptic Drug (AED) Tapering Phase |
0.475 | — |
| SECONDARY The Cumulative Exit Rate at 112 Days for the Keppra XR 1000 mg Group After the Beginning of the Previous Antiepileptic Drug (AED) Tapering Phase |
0.334 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female subjects 12 to 75 years of age.
- Subjects must have inadequately controlled partial onset epilepsy.
- Subjects must be experiencing 2 to 40 seizures per 4-week period while being maintained on one or two standard AED(s)
Exclusion Criteria
- A history of status epilepticus in the 6 months preceding randomization.
- Significant medical, psychiatric or neurological illness.
- Intake of benzodiazepines on more than an occasional basis
- History of previous treatment with levetiracetam or sensitivity to levetiracetam.
Data sourced from ClinicalTrials.gov (NCT00419094). 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.