Comparing long term safety of LCM vs CBZ-CR in patients from SP0993

• Research type

  Research Study

• Full title

  A multicentre, double-blind, double-dummy follow-up study evaluating the long-term safety of lacosamide (200 to 600mg/day) in comparison with carbamazepine (400 to 1200mg/day), used as monotherapy in subjects with partial-onset or generalised tonic-clonic seizures (=16 years of age) coming from the SP0993 study

• IRAS ID

  71042

• Contact name

  Anthony Marson

• Sponsor organisation

  UCB BIOSCIENCES GmbH

• Eudract number

  2010-021238-74

• 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. However, more than 30% of patients have inadequate seizure control on currently available Anti Epileptic Drugs, therefore a need remains for AEDs with improved effectiveness and tolerability.Lacosamide is a drug that has been developed by UCB BioSciences GmbH, as add-on therapy for the treatment of partial-onset seizures. UCB BioSciences GmbH, is sponsoring this follow up study to compare the long term 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, experiencing partial onset or tonic-clonic seizures.Patients who participated in the SP09903 study will be invited to take part in this study. The same study drug given to patients during SP09903 will be given to patients in this study. This is a double blind study meaning that neither the patient nor the study doctor will know which medication is being given. After the study closure of SP0993 patients will be told if they had received lacosamide or Carbamazepine Controlled Release, this is called unblinding. 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 study will involve approximately to 527 participants (equivalent to 60% of all patients randomized to SP0993) across approximately 14 countries over Australia, Europe and Canada. This is a follow up study, meaning patients will have the option to join this study after completing the SP0993 study.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  11/NW/0412

• Date of REC Opinion

  10 Oct 2011

• REC opinion

  Further Information Favourable Opinion