Study comparing controlled monotherapy Lacosamide vs Carbamazepine
Research type
Research Study
Full title
A MULTICENTRE, DOUBLE BLIND, DOUBLE DUMMY, RANDOMISED, POSITIVE CONTROLLED STUDY COMPARING THE EFFICACY AND SAFETY OF LACOSAMIDE (200 TO 600MG/DAY) TO CONTROLLED RELEASE CARBAMAZEPINE (400 TO 1200MG/DAY), USED AS MONOTHERAPY IN SUBJECTS (=16 YEARS) NEWLY OR RECENTLY DIAGNOSED WITH EPILEPSY AND EXPERIENCING PARTIAL ONSET OR GENERALISED TONIC CLONIC SEIZURES
IRAS ID
61620
Contact name
Anthony Marson
Sponsor organisation
SCHWARZ BIOSCIENCES GmbH
Eudract number
2010-019765-28
Clinicaltrials.gov Identifier
Research summary
Epilepsy is a disorder of the nervous system, characterised by unprovoked seizures. More than 40 million People'suffer from epilepsy and about 1% of the world??s population. There are different types of seizures that someone with epilepsy may suffer from. The partial-onset seizures only affect a part of the brain; the sufferer usually retains consciousness. Partial-onset seizures are often precursors to larger seizures that spread to larger areas of the brain. The tonic-clonic seizures are a type of generalised seizure that affects the entire brain, the sufferer loses consciousness and their muscles begin to contract and relax rapidly, causing convulsions.Although some forms of epilepsy may respond to surgical treatment and others may not require any treatment at all, most patients with epilepsy require appropriate medication. In the past decade, several new options for the treatment of epilepsy have been introduced, including novel anti-epileptic drugs (AEDs). However, more than 30% of patients have inadequate seizure control on currently available AEDs, therefore a need remains for AEDs with improved effectiveness and tolerability.Lacosamide is a drug that has been developed by UCB BioSciences GmbH, a member of the UCB group of companies, as add-on therapy for the treatment of partial-onset seizures. UCB BioSciences GmbH, a member of the UCB group of companies, is sponsoring a study to compare the safety and efficacy of lacosamide against Carbamazepine Controlled Release?? one of the most widely used AEDs in the world - in patients 16 years and older, newly or recently diagnosed with epilepsy, experiencing partial onset or tonic-clonic seizures.This is a randomised, double blind, study meaning that neither the patient nor the study doctor will know which medication is being given. The study is also double-dummy meaning all patients are given both placebo (drug has no medical effect) and active doses of either lacosamide or carbamazepine.This is a multicentre study which will take place across approximately 120 centres in Europe, Canada, Australia and other regions. It is anticipated that approximately 1000 patients will be recruited worldwide.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
11/NW/0411
Date of REC Opinion
10 Oct 2011
REC opinion
Further Information Favourable Opinion