Phase 3
Completed N=190
Long Term Follow-up Study With Keppra XR (Levetiracetam XR) for Partial Seizures
Source: ClinicalTrials.gov NCT00419393 ↗Enrolled (actual)
190
Serious AEs
11.6%
Results posted
Jul 2011
Primary outcomePrimary: Number of Subjects Who Experienced at Least 1 Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years) — 126 number of subjects
Summary
To provide continued treatment of Keppra XR (Levetiracetam XR) and to assess the long term safety of Keppra XR in subjects with partial onset seizures.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Who Experienced at Least 1 Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years) |
126 | — |
| PRIMARY Number of Subjects Who Experienced at Least 1 Serious Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years) |
22 | — |
| PRIMARY Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event During the Actual Treatment Period |
5 | — |
| SECONDARY Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 6 Months |
77.0 | — |
| SECONDARY Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 12 Months |
65.3 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who were randomized into study N01280 [NCT00419094], and completed the 2 week up titration period
Exclusion Criteria
- Subjects who did not meet the inclusion/exclusion criteria for N01280 [NCT00419094]
- Subjects who were discontinued prior to the end of titration period
Data sourced from ClinicalTrials.gov (NCT00419393). 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.