NCT01969851

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.

A MULTI-CENTER, OPEN-LABEL, EXPLORATORY STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF LACOSAMIDE AS ADJUNCTIVE THERAPY IN SUBJECTS ≥1 MONTH TO <18 YEARS WITH EPILEPSY SYNDROMES ASSOCIATED WITH GENERALIZED SEIZURES.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 1 Month – 18 Years
• Healthy volunteers: Not accepted

Summary

SP0966 is an exploratory study to investigate safety and efficacy of Lacosamide (LCM) in children with epilepsy syndromes associated with generalized seizures. LCM will be added to current antiepileptic treatment.

Detailed description

SP0966 is a Phase 2, multicenter, open-label exploratory study designed to assess the safety and preliminary efficacy of oral lacosamide as adjunctive therapy for epilepsy syndromes associated with generalized seizures in pediatric subjects ≥1 month to \<18 years of age.

Conditions

• Epilepsy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-02-13
• Primary completion: 2018-04-10
• Completion: 2018-04-10
• First posted: 2013-10-25
• Last updated: 2019-05-07
• Results posted: 2019-05-07

Locations

18 sites across 5 countries: United States, France, Hungary, Mexico, Poland