NCT00938912

An Open-Label Study to Determine Safety , Tolerability, and Efficacy of Oral Lacosamide in Children With Epilepsy

An Open-Label Study To Determine Safety, Tolerability And Efficacy Of Long -Term Oral Lacosamide (LCM) As Adjunctive Therapy In Children With Epilepsy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 366 (actual)
• Sponsor: UCB BIOSCIENCES, Inc. · Industry
• Sex: All
• Age: 1 Month – 17 Years
• Healthy volunteers: Not accepted

Summary

SP848 is an open-label study to evaluate long-term safety, tolerability, and efficacy in children with epilepsy treated with Lacosamide (LCM) oral solution (syrup) or LCM tablets as adjunctive therapy.

Detailed description

SP848 is an open-label study to evaluate long-term safety, tolerability, and efficacy in children with epilepsy treated with Lacosamide (LCM) oral solution (syrup) or LCM tablets as adjunctive therapy. In addition, the study is designed to provide continued availability of LCM to subjects who have completed the SP847 (NCT00938431) study and to subjects who have discontinued from SP847 (NCT00938431) and who, in the investigator's opinion, would benefit from long-term administration of LCM. SP848 will be open to subjects who have participated in other LCM pediatric clinical studies in epilepsy and will also be open to up to 100 subjects enrolling directly into SP848. Permissible LCM doses in SP848 are between 2-12 mg/kg/day (oral solution \[syrup\]) or the corresponding tablet dose up to a maximum dose of 600 mg/day. Subjects enrolled in SP848 have the option of remaining on the oral solution formulation of LCM or switching to the commercial tablet formulation, if feasible.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	Lacosamide	Lacosamide oral solution (syrup): Total daily dose between 2 mg/kg/day (1 mg/kg bid) to 12 mg/kg/day (6 mg/kg bid)
DRUG	Lacosamide	Lacosamide tablets: Total daily dose between 100 mg (50mg bid) - 600mg (300 mg bid). The maximum permissible dose of LCM will be 12 mg/kg/day or 600 mg/day.

Timeline

• Start date: 2009-12-09
• Primary completion: 2021-05-18
• Completion: 2021-05-18
• First posted: 2009-07-14
• Last updated: 2022-01-18
• Results posted: 2022-01-18

Locations

69 sites across 11 countries: United States, Belgium, China, France, Germany, Hungary, Italy, Japan, Mexico, Poland, Ukraine