NCT02477839

Efficacy and Safety of Lacosamide as Adjunctive Therapy in Subjects ≥1 Month to <4 Years With Partial-onset Seizures

A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Lacosamide as Adjunctive Therapy in Subjects With Epilepsy >=1 Month to <4 Years of Age With Partial-Onset Seizures

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 255 (actual)
• Sponsor: UCB BIOSCIENCES, Inc. · Industry
• Sex: All
• Age: 1 Month – 47 Months
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to assess the efficacy, safety and tolerability of lacosamide administered as add-on therapy with 1 to 3 anti-seizure medications. This trial is for children aged 1 month to less than 4 years with epilepsy who currently have uncontrolled partial-onset seizures.

Detailed description

The trial consists of a 7-day Baseline Period, a 20-day Titration Period, a 7-day Maintenance Period, and a 12-day Transition Period for subjects who complete the study and choose to enter the extension study. Subjects who will not enter the extension study will continue after the Maintenance Period with a 16-day Taper Period followed by a 30-day Safety Follow-Up Period. The Taper Period and Safety Follow-Up are also applicable for subjects not eligible for continuation and therefore ending the study earlier. If subjects meet the eligibility criteria, they will be randomized to receive either lacosamide 8 mg/kg/day to 12 mg/kg/day, or placebo during the Maintenance Phase. The dose of lacosamide will be titrated from 4 mg/kg/day at study start to maximum of 12 mg/kg/day at 4-day intervals of 1-2 mg/kg/day. All subjects who complete the 20-day Titration Period will enter the 7-day Maintenance Period. No dose adjustment is allowed during the Maintenance Phase. The Treatment Phase is defined as the combined Titration and Maintenance Phases.

Conditions

• Epilepsy With Partial-onset Seizures

Interventions

Type	Name	Description
DRUG	Lacosamide	Active Substance: Lacosamide Pharmaceutical Form: Syrup Concentration: 10 mg/mL Route of Administration: oral
OTHER	Placebo	Active Substance: Placebo Pharmaceutical Form: Syrup Concentration: N/A Route of Administration: oral

Timeline

• Start date: 2015-06-05
• Primary completion: 2020-05-28
• Completion: 2020-05-28
• First posted: 2015-06-23
• Last updated: 2021-07-01
• Results posted: 2021-07-01

Locations

88 sites across 26 countries: United States, Argentina, Brazil, Bulgaria, China, Croatia, Czechia, France, Georgia, Greece, Hungary, Israel, Italy, Mexico, Moldova, Philippines, Poland, Portugal, Romania, Russia, Serbia, Slovakia, South Korea, Taiwan, Thailand, Ukraine