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Clinical trial

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

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Last updated:5th Jun 2015
Identifier: NCT02477839

Brief Summary:
The purpose of this trial is to assess the efficacy, safety and tolerabilty 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.


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 244 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date: June 5, 2015
Estimated Primary Completion Date: June 2020
Estimated Study Completion Date: June 2020

Arms:
- Experimental:
Lacosamide
- Placebo Comparator: Placebo

Category Value
Date last updated at source 2019-03-24
Study type(s) Interventional
Expected enrolment 244
Study start date 2015-06-05
Estimated primary completion date 2020-06-01

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