NCT02192814

Open-label Study to Evaluate the Safety and Tolerability of iv Lacosamide in Japanese Adults With Partial-onset Seizures

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: UCB Japan Co. Ltd. · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Epilepsy
• Partial-onset Seizures

Interventions

Type	Name	Description
DRUG	Lacosamide (200 mg/20 mL)	Active Substance: Lacosamide Pharmaceutical form: Solution for intravenous (iv) infusion Concentration: adapted on concentration of oral dose in EP0009 Route of Administration: Drip infusion

Timeline

• Start date: 2014-06-01
• Primary completion: 2014-10-01
• Completion: 2014-12-01
• First posted: 2014-07-17
• Last updated: 2017-08-25
• Results posted: 2015-12-04

Locations

5 sites across 1 country: Japan