NCT02124564

A Trial to Evaluate the Long Term Safety and Tolerability of Lacosamide Taken as Monotherapy in Adults With Partial-onset Seizures

Multicenter, Open-Label, Long-Term Study to Investigate the Safety of Conversion to Lacosamide at Doses up to 600 mg/Day as Monotherapy in Japanese Adults With Partial-Onset Seizures With or Without Secondary Generalization

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: UCB Japan Co. Ltd. · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

This study is to evaluate the long-term safety and tolerability of Lacosamide (LCM) 200 mg/day to LCM 600 mg/day taken in monotherapy in Japanese subjects who currently have partial-onset seizures with or without secondary generalization and who are treated with a single Anti-Epileptic Drug (AED) with marketing approval in Japan.

Conditions

• Epilepsy
• Partial-onset Seizures

Interventions

Type	Name	Description
DRUG	Lacosamide	Lacosamide (LCM) immediate-release, film-coated tablets at a strength of 50 mg orally administered twice daily in two equally divided doses. * 4-week Titration Period: Starting on LCM 100 mg/day increased by 100 mg/day each week until 400 mg/day dose reached at the beginning of Week 4 . * The AED Withdrawal Period and Monotherapy Period (52- week Evaluation Period plus a Follow Up Period): During the AED Withdrawal and Monotherapy Period, the investigator may increase or decrease the dose of LCM to optimize tolerability and seizure control. The LCM dose may be decreased no lower than 200 mg/day or increased, no faster than 100 mg/day per week, up to 600 mg/day.

Timeline

• Start date: 2014-04-01
• Primary completion: 2017-11-21
• Completion: 2017-11-21
• First posted: 2014-04-28
• Last updated: 2019-10-28
• Results posted: 2019-06-28

Locations

11 sites across 1 country: Japan