NCT01832038

Study to Evaluate the Safety, Tolerability, and Efficacy of Long-term Adjunctive Therapy With Lacosamide in Adults With Partial-onset Seizures

A Multi-center, Open-label, Uncontrolled, Long-term, Extension Study to Evaluate the Safety and Efficacy of Lacosamide as Adjunctive Therapy in Japanese and Chinese Adults With Partial-onset Seizures With or Without Secondary Generalization

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 473 (actual)
• Sponsor: UCB Pharma SA · Industry
• Sex: All
• Age: 16 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to evaluate the safety and tolerability of long-term administration of Lacosamide at doses up to 400 mg/day in Japanese and Chinese adults with Epilepsy who have completed the Treatment and Transition Period of EP0008 \[NCT01710657\]

Conditions

• Epilepsy
• Partial-onset Seizures

Interventions

Type	Name	Description
DRUG	Lacosamide	Strength: Lacosamide (LCM) 50 mg, LCM 100 mg Formulation: Tablet Frequency: twice daily during the study period (until the date of approval) At the completion of EP0008 \[NCT01710657\], all subjects who choose to enroll in EP0009 will be taking a dose of Lacosamide 200 mg/day. At the beginning of EP0009, the investigator may maintain the LCM dose or increase or decrease the dose. During the Treatment Period, the investigator will be allowed to increase or decrease the dose of LCM to optimize tolerability and seizure reduction. The LCM dose may be decreased to 100 mg/day or increased, no faster than 100 mg/day per week, up to 400 mg/day.

Timeline

• Start date: 2013-03-26
• Primary completion: 2019-07-31
• Completion: 2019-07-31
• First posted: 2013-04-15
• Last updated: 2021-08-17
• Results posted: 2020-08-13

Locations

67 sites across 2 countries: China, Japan