Phase 3
Completed N=9
Open-label Study to Evaluate the Safety and Tolerability of iv Lacosamide in Japanese Adults With Partial-onset Seizures
Source: ClinicalTrials.gov NCT02192814 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Dec 2015
Primary outcomePrimary: The Total Number of Subjects Experiencing at Least One Adverse Event During the Study — 4 participants
Summary
EP0024 is a Phase 3, multicenter, open-label study to evaluate the safety and tolerability of intravenous (iv) lacosamide (LCM). Adjunctive iv LCM therapy (200 mg/day to 400 mg/day) will be administered for 5 days as replacement for oral LCM tablets in Japanese adults with partial-onset seizures.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Total Number of Subjects Experiencing at Least One Adverse Event During the Study |
4 | — |
| PRIMARY The Total Number of Subject Withdrawal Due to Adverse Events During the Study |
— | — |
| SECONDARY Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 1 |
4.738 | — |
| SECONDARY Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 2 |
4.004 | — |
| SECONDARY Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 5 |
3.615 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 1 |
10.838 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 2 |
10.330 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 5 |
9.621 | — |
Eligibility Criteria
Inclusion Criteria
- Subject is Japanese and enrolled in EP0009 (NCT01832038) receiving oral Lacosamide (LCM) for the treatment of partial-onset seizures and has been enrolled for at least 8 weeks
- Subject has been on a stable twice daily (bid) dosage regimen of LCM 200 mg/ day to 400 mg/ day, for the 2 weeks prior to entry into EP0024
- Subject has been receiving no more than 3 concomitant Antiepileptic Drugs (AEDs) at doses that have remained stable for the 2 weeks prior to entry into EP0024
Exclusion Criteria
- Subject has a history of any kind of status epilepticus within 12-month period prior to study entry
- Subject has actual suicidal ideation as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the "Since Last Visit" version of the Columbia-Suicide Severity Rating Scale (C-SSRS)
Data sourced from ClinicalTrials.gov (NCT02192814). 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.