A Study to Investigate the Safety and Efficacy of Lacosamide Added to the Patients Current Therapy in Patients Aged 1 Month to Less Than 18 Years Old With Epilepsy Syndromes Associated With Generalized Seizures.

PHASE2CompletedINTERVENTIONAL
Enrollment

55

Participants

Timeline

Start Date

February 13, 2014

Primary Completion Date

April 10, 2018

Study Completion Date

April 10, 2018

Conditions
Epilepsy
Interventions
DRUG

Lacosamide

"Oral intake twice daily of tablet (100 mg or 50 mg) or syrup formulation (10 mg/ml).~Total daily dose will be titrated over a period of 6 weeks with starting dose of 100 mg/day or 2 mg/kg/day up to doses not exceeding 600 mg/day or 12 mg/kg/day tablet or syrup, respectively. Followed by a 12 week maintenance period with stable dosing of at least 200 mg/day or 4 mg/kg/day tablet or syrup, respectively."

Trial Locations (18)

Unknown

103, Los Angeles

101, Orlando

104, Henderson

112, Hackensack

108, New Brunswick

107, Akron

309, Ile-De-France

303, Lyon

701, Budapest

702, Budapest

703, Budapest

704, Budapest

705, Debrecen

154, Guadalajara

807, Katowice

801, Krakow

805, Lublin

802, Szczecin

Sponsors

Lead Sponsor

All Listed Sponsors
lead

UCB Pharma

INDUSTRY