Lacosamide in Subjects ages 4 years and over and less than 17 with Epil
Research type
Research Study
Full 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 4 Years and over and less than 17 Years Of Age With Partial Onset Seizures
IRAS ID
136902
Contact name
Marian McGowan
Contact email
Sponsor organisation
UCB BIOSCIENCES Inc.
Eudract number
2012-004996-38
Clinicaltrials.gov Identifier
Research summary
This is a phase III, randomised, double-blind, placebo-controlled study of lacosamide as adjunctive therapy in subjects with epilepsy ≥4 years to <17 years of age with partial onset seizures.
Epilepsy is a common and diverse set of chronic neurological disorders and is the second most prevalent neurological disorder in the world. The condition is characterised by seizures (also known as fits) caused by a sudden burst of excess electrical activity in the brain, which temporarily disrupts the normal message passing between brain cells.
Epilepsy is usually controlled, but not cured, with medication. However, more than 30% of people with epilepsy do not have seizure control even with the best available medications. This is especially challenging for paediatric patients.
The purpose of this study is to determine how effective and safe lacosamide is as an adjunctive therapy in treating children ages 4 to 17 with partial-onset seizures. Lacosamide has been approved as adjunctive therapy in the treatment of partial onset seizures in patients over the age of 17 in the USA and in patients 16 years and older in the EU.
A total of approximately 300 subjects with uncontrolled partial onset seizures will
be enrolled at approximately 149 sites in North America, Europe, Latin America, the Asia/Pacific. The maximum duration of a subject’s study participation is up to 36 weeks with a duration of study medication administration of 24 weeks.The study consists of an 8 week Baseline Period, a 6 week Titration Period, a 10 week Maintenance Period, and a Transition Period for those who plan to participate in the open-label extension study.
Eligible patients will be randomly assigned into one of two treatment arms: lacosamide or placebo.There is also a 2-4 week blinded Taper Period for subjects who will not be entering the open-label extension study.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
14/YH/0007
Date of REC Opinion
4 Mar 2014
REC opinion
Further Information Favourable Opinion