Long-term use/safety of Lacosamide Monotherapy for partial seizures
Research type
Research Study
Full title
A Multi-centre Open-Label Extension Trial to Assess the Long-term use of Lacosamide Monotherapy and Safety of Lacosamide Monotherapy and Adjunctive Therapy in Subjects with Partial onset seizures
IRAS ID
6201
Sponsor organisation
Schwarz Biosciences, Inc.
Eudract number
2007-005440-25
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
Research summary
Epilepsy is the most prevalentneurological disorder in the world. Currently more than 30% of patients haveinadequate seizure control on currently available anti-epileptic drugs orexperience significant adverse drug effects. Monotherapy treatment is likely toresult in a lower incidence of adverse events thus improved tolerability,decreased drug interaction and lower medical costs. It should also lead togreater subject compliance. This study will see if the long term use ofLacosamide (LCM), when taken alone or with other anti-epileptic drugs, is safeand if it affects the type, number, length and severity of seizures. Subjectswho participated in the SP902 study may be eligible for this open-label study.The study will last 2 years or until the drug becomes commercially available.There will be 13 visits during the study and these will be spaced 4, 8 and 12weeks apart as the study progresses. Patients will benefit from frequentevaluations and close monitoring by a physician. Seizures may improve, howeverthis cannot be guaranteed. Future subjects may also benefit from the knowledgegained in this trial. Procedures undertaken during the study include a physicaland neurological assessment by the physician, assessment of AEs, 12 Lead ECG, asmall blood sample, blood pressure and pulse. A diary card will be completeddaily by the subject. 3 tablets will be taken twice daily. Subjects will bereceiving either 300 or 400mg/day LCM at the end of the SP902 trial. The doctorcan increase or decrease the dose from 100mg/day to 800mg/day to allow for thebest seizure control and lessen side effects. This may only be increased ordecreased by 100mg/week. The doctor may also add other AEDs or mayincrease/decrease the doses of the other AEDs. Unscheduled visits may benecessary if the doctor wants to change the dose of medication or repeat anylab tests.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
08/H0311/135
Date of REC Opinion
12 Nov 2008
REC opinion
Further Information Favourable Opinion