A study of Standard and New Antiepileptic Drugs – SANAD-II
A pragmatic randomised controlled trial comparing the effectiveness and cost effectiveness of levetiracetam and zonisamide versus standard treatments for epilepsy: a comparison of Standard And New Antiepileptic Drugs (SANAD-II)
SANADII is a phase IV multicentre pragmatic randomised controlled trial comparing the effectiveness and cost-effectiveness of levetiracetam and zonisamide versus standard treatments (lamotrigine and valproate) for epilepsy. Epilepsy is a common neurological condition. It is uniquely stigmatising and has a negative impact on quality of life and employment prospects. Antiepileptic drugs are the mainstay of treatment and may have to be taken for life. The ultimate goal of treatment is to maximise quality of life by eliminating seizures at drug doses that do not cause side effects. However, for many patients there is a necessary trade-off between effective seizure control and side effects, which can diminish quality of life. Over the past 20 years, a number of new AED drugs have become available and have been approved for NHS use on the basis of information from short term trials. These trials do not provide information about the longer term outcomes which inform decisions made by doctors and patients, nor do they provide any useful health economic data. SANADII will essentially be two randomised controlled trials run in parallel. Arm A of SANADII will compare lamotrigine, levetiracetam and zonisamide in patients with untreated focal onset seizures. Arm B of SANADII will compare levetiracetam and valproate in patients with generalised onset seizures or seizures that are difficult to classify. It will aim to accrue about 1510 patients (children aged 5 or older and adults) over a 3.5 year period and follow up will continue for a further two years (a maximum time a patient will receive randomised treatment is 5.5 years). There will be economy of scale given that the protocols and data structure are almost identical and that the same group of collaborators will be recruiting patients to both trials. There will be no competition for patients between Arm A and Arm B as the inclusion criteria are mutually exclusive. All treatments will be prescribed and issued as per routine NHS.
North West - Liverpool Central Research Ethics Committee
Date of REC Opinion
7 Jun 2012
Further Information Favourable Opinion