At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 9 enrolled
Drug / intervention
Lacosamide (200 mg/20 mL)drug
Likely dose
Lacosamide (200 mg/20 mL)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Open-label Study to Evaluate the Safety and Tolerability of Intravenous Lacosamide as Replacement for Oral Lacosamide in Japanese Adults With Partial-onset Seizures With or Without Secondary Generalization
In Brief
A Phase 3 clinical trial evaluating Lacosamide (200 mg/20 mL) for Epilepsy and Partial-onset Seizures. Completed, enrolled 9 participants across 5 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy, Partial-onset Seizures
CountriesJapan
CollaboratorsParexel
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartJun 2014
First PostedJul 2014
Primary CompletionOct 2014
Study CompletionDec 2014
TodayJul 2026
First PostedJul 17, 2014
Enrollment StartJun 1, 2014
Primary CompletionOct 1, 2014
Study CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 12.0 years ago
Interventions
Lacosamide (200 mg/20 mL)drug
Active Substance: Lacosamide Pharmaceutical form: Solution for intravenous (iv) infusion Concentration: adapted on concentration of oral dose in EP0009 Route of Administration: Drip infusion