Phase 2
Completed N=39
Open-Label Extension Study to Assess the Safety and Seizure Frequency Associated With Lacosamide for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy
Source: ClinicalTrials.gov NCT01118962 ↗Enrolled (actual)
39
Serious AEs
7.7%
Results posted
Dec 2013
Primary outcomePrimary: Number of Participants With Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (Approximately 61 Weeks) — 37 participants
Summary
The purpose is to obtain data on the safety and seizure frequency associated with long-term oral Lacosamide for uncontrolled primary generalized tonic-clonic (PGTC) seizures in subjects with idiopathic generalized Epilepsy. Additionally, to allow subjects who have completed SP0961 (NCT01118949) to continue to receive Lacosamide.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (Approximately 61 Weeks) |
37 | — |
| PRIMARY Number of Participants Withdrawn From the Study Due to Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (Approximately 61 Weeks) |
2 | — |
Eligibility Criteria
Inclusion Criteria
- Subject completed the SP0961 (NCT01118949) study
- Subject is expected to benefit from participation in an open-label extension study with Lacosamide, in the opinion of the investigator
Exclusion Criteria
- Subject meets the withdrawal criteria for SP0961 (NCT01118949) or is experiencing an ongoing Serious Adverse Event (SAE)
Data sourced from ClinicalTrials.gov (NCT01118962). 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.