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

PHASE3CompletedINTERVENTIONAL
Enrollment

19

Participants

Timeline

Start Date

April 30, 2014

Primary Completion Date

November 21, 2017

Study Completion Date

November 21, 2017

Conditions
EpilepsyPartial-onset Seizures
Interventions
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."

Trial Locations (11)

Unknown

5, Asaka

1, Hamamatsu

11, Itami

6, Kagoshima

7, Kamakura

10, Nagoya

12, Saitama

8, Sapporo

13, Shinagawa City

4, Shizuoka

9, Toyonaka

All Listed Sponsors
lead

UCB Japan Co. Ltd.

INDUSTRY

NCT02124564 - A Trial to Evaluate the Long Term Safety and Tolerability of Lacosamide Taken as Monotherapy in Adults With Partial-onset Seizures | Biotech Hunter | Biotech Hunter