Phase 3
N=190
Long Term Follow-up Study With Keppra XR (Levetiracetam XR) for Partial Seizures
Epilepsy
Bottom Line
View on ClinicalTrials.gov: NCT00419393 ↗Enrolled (actual)
190
Serious AEs
11.6%
Results posted
Jul 2011
Primary outcome: Primary: 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
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Keppra XR (Levetiracetam XR) (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- UCB Pharma
- Primary completion
- Mar 2010
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 | — |
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.
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.