Phase 3
Completed N=97
Study to Assess the Long-term Safety of Oral Lacosamide in Subjects With Partial-onset Seizures
Partial Epilepsies · Partial-Onset Seizures
Source: ClinicalTrials.gov NCT00655486 ↗
Enrolled (actual)
97
Serious AEs
10.3%
Results posted
Jul 2011
Primary outcomePrimary: Number of Subjects With at Least One Adverse Event During This Open-label Extension Study (Maximum Study Duration 2 Years) — 93 subjects
Summary
The purpose of this study is to allow eligible subjects from the parent study, SP925 [NCT00655551] to continue lacosamide and to obtain additional long-term safety data
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With at Least One Adverse Event During This Open-label Extension Study (Maximum Study Duration 2 Years) |
93 | — |
| PRIMARY Number of Subjects Who Withdrew From the Study Due to an Adverse Event (Maximum Study Duration 2 Years) |
10 | — |
Eligibility Criteria
Inclusion Criteria
- Eligible subjects who participated in SP925 [NCT00655551] for treatment of partial-onset seizures
Exclusion Criteria
- Receiving any study drug or experimental device other than lacosamide
- Meets withdrawal criteria for parent study SP925 [NCT00655551]
- Experiencing ongoing serious adverse event
Data sourced from ClinicalTrials.gov (NCT00655486). 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.