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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. Our previous trial SANAD-I compared the effectiveness and cost effectiveness of standard and new treatments that were available at that time. SANAD-I identified lamotrigine a new drug as an effective and cost-effective first-line treatment for patients with a focal epilepsy, and confirmed that valproate a standard treatment should remain a first-line drug for patients with a generalised epilepsy or seizures that clinicians find difficult to classify. Since SANAD-I, a number of newer treatments have become available, the most promising of which are levetiracetam and zonisamide. We now need to assess whether levetiracetam or zonisamide should become first-line treatments. In SANAD-II, we propose to assess the longer term effectiveness and cost effectiveness of these drugs in two un-blinded randomised controlled trials run in parallel. The first arm A will compare lamotrigine, levetiracetam and zonisamide in patients with a focal epilepsy, and the second arm B will compare levetiracetam with valproate in patients with a generalized epilepsy or seizures that the clinician finds difficult to classify. The SANAD II study of effectiveness of valproate or levetiracetam in generalised and unclassifiable epilepsy: an un-blinded randomised controlled trial. Abstract: Bonnett, L. Risk of a seizure recurrence after a breakthrough seizure and the implications for driving: further analysis of the standard versus new antiepileptic drugs SANAD randomised controlled trial. Treatment outcome after failure of a first antiepileptic drug. Time to month remission and treatment failure for generalised and unclassified epilepsy. Health Technology Assessment monograph, 11 A comparison of different joint models for longitudinal and competing risks data: with application to an epilepsy drug randomised control trial. One-stage individual participant data meta-analysis models: estimation of treatment-covariate interactions must avoid ecological bias by separating out within-trial and across-trial information. Statistics in medicine, 36 5 , Quality-of-life outcomes of initiating treatment with standard and newer antiepileptic drugs in adults with new-onset epilepsy: Findings from the SANAD trial. Carbamazepine, gabapentin, lamotrigine, oxcarbazepine or topiramate for partial epilepsy: results from the SANAD trial. Valproate, lamotrigine or topiramate for generalized and unclassifiable epilepsy: results from the SANAD trial. Health Technology Assessment 11 Nevitt, S. Antiepileptic drug monotherapy for epilepsy: a network meta-analysis of individual participant data. Trials Multiple treatment comparisons in epilepsy monotherapy trials. Resource implications of preparing individual participant data from a clinical trial to share with external researchers. Joint modelling of longitudinal and competing risks data. Statistics in Medicine Learn more I agree.

A study of Standard and New Antiepileptic Drugs – SANAD-II

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This site uses session cookies and persistent cookies to improve the content and structure of the site. By clicking ' See cookie policy ' you can review and change your cookie preferences and enable the ones you agree to. By dismissing this banner , you are rejecting all cookies and therefore we will not store any cookies on this device. 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. It will aim to accrue about patients children aged 5 or older and adults over a 3. 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. The Health Research Authority website uses essential cookies. Glossary Search glossary. Stay up to date with latest news, updates to regulations and upcoming learning events. Site by Big Blue Door.

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