Conversion to Lacosamide Monotherapy with partial seizures (SP902)
Research type
Research Study
Full title
A Historical-controlled, Multi-Centre, Double-Blind, Randomized Trial to Assess the Efficacy and Safety of Conversion to Lacosamide 400mg/day Monotherapy in Subjects with Partial-onset Seizures
IRAS ID
5312
Sponsor organisation
Schwarz Biosciences, Inc.
Eudract number
2007-005439-27
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
Research summary
Epilepsy is the second most prevalentneurological disorder in the world. Although some forms of epilepsy respond tosurgical treatment and others may not require treatment at all, most patientsrequire appropriate therapy. More than 30% of patients have inadequate seizurecontrol on currently available Anti-Epileptic Drugs(AEDS). Therefore needremains for AEDs with improved effectiveness and tolerability. This trial isbased on the evaluation of 8 historical control trials as described in a whitepaper (Jackie French et al, 2005). The methods used to analyse these resultsmust be consistent with the white paper. The purpose of this trial is to see ifLacosamide, when taken alone(monotherapy), affects the type, number, length,and severity of seizures. It is also to find out if there are side effects whenLacosamide is used without other anti-epileptic drugs. Subjects withpartial-onset seizures already taking 1 or 2 anti-epileptic drugs will randomlybe assigned to Lacosamide at either 400mg per day or 300mg per day. This dosewill be in tablet form and prescribed as 3 tablets, twice daily. Once theassigned dose of Lacosamide has been reached the subject's other anti-epilepticdrugs will be reduced over a 6 week period followed by a 10 week period duringwhich the subject takes Lacosamide only. It is planned to enrol 357 subjects at100 sites in the USA and Europe. The study will last 30 weeks and will involve13-14 visits. Patients will be asked to complete diaries clearly to evaluatethe type, number, length and severity of their seizures. Subjects will beclosely monitored throughout the trial. Monotherapy is likely to result in alower incidence of AEs, improving tolerability, decreasing the risk of druginteractions and lowering medication costs. It is also likely to result in greatersubject compliance.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
08/H0311/134
Date of REC Opinion
12 Nov 2008
REC opinion
Further Information Favourable Opinion