CompletedBrain & Nervous SystemPregnancy, Children & Inherited Conditions
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)
Levetiracetam and zonisamide, two newer epilepsy drugs, are being tested head-to-head against standard treatments in a large trial called SANAD-II. This matters because most evidence for newer antiepileptic drugs comes from short-term trials that do not tell doctors how well the drugs work over years of use, nor whether they are worth the cost to the NHS. Patients often face a trade-off between seizure control and side effects that erode quality of life, and longer-term data is needed to guide those decisions. The trial compares levetiracetam and zonisamide against lamotrigine and valproate in two parallel arms: one for focal onset seizures, another for generalised or hard-to-classify seizures. If the newer drugs prove more effective or cost-effective over the long term, they could replace current first-line treatments, improving seizure control and quality of life for people with epilepsy. If they do not, the NHS can avoid switching to more expensive options without clear benefit. The results will directly inform prescribing guidelines and health policy.
View original technical description
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 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. SANADII is essentially two randomised controlled trials run in parallel. Arm A of SANADII is comparing lamotrigine, levetiracetam and zonisamide in patients with untreated focal onset seizures. Arm B of SANADII is comparing levetiracetam and valproate in patients with generalised onset seizures or seizures that are difficult to classify. SANADII aims 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). Arm B closed to recruitment in August 2016 after reaching its recruitment target. Arm A, however, will continue recruiting for an additional year (until end of May 2017) in order to reach its recruitment target. 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 practice.
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