Background

Epilepsy is a central nervous system disorder. Most seizures (fits) can be controlled by a single antiepileptic medicine. Unfortunately, some people require more than one antiepileptic medicine to control their seizures (called refractory epilepsy or drug-resistant epilepsy), especially if these originate from one area of the brain (focal epilepsy), instead of being generalised (involve the entirety of the part of the brain called the cerebral cortex). Rufinamide is a novel anticonvulsant medicine that is structurally unrelated to any other currently used anticonvulsant medicine. In 2009, rufinamide was approved by the US Food and Drug Administration for the treatment of children aged four years and older with Lennox-Gastaut syndrome (a childhood epilepsy) and then also approved as an ‘add-on’ treatment (given in addition to the usual anticonvulsant medicine) for adults and adolescents with focal seizures.

Aim of the review

This review aimed to evaluate the effectiveness and side effects of rufinamide when used as an add-on treatment for people with drug-resistant epilepsy.

Results

We found six clinical trials that included in analysis 1759 people with focal epilepsy. These trials were all randomised controlled trials (clinical studies where people were randomly put into one of two or more treatment groups) that compared the antiepileptic drug rufinamide (at doses between 200 mg per day and 3200 mg per day) plus a conventional antiepileptic medicine to a placebo (pretend tablet) plus a conventional epileptic medicine for up to 96 days.

The review found that rufinamide, used in combination with other antiepileptic drugs in people who had drug-resistant focal epilepsy decreased the frequency of seizures further. The review also showed that rufinamide seemed to be associated with more side effects such as dizziness, tiredness, headache, double vision, nausea and vomiting compared to placebo but more information is needed about some of these events.

The evidence is current to October 2017.

Quality of the evidence

We assessed the trials with regards to risk of bias and quality. Overall, five studies had low risk of bias, and one study had unclear risk of bias due to lack of reported information around study design. All studies were conducted by the pharmaceutical industry. We rated the quality of the evidence as moderate to low as some data were not reported and some information about the trials was unclear. Further trials are needed to assess the long-term effects of rufinamide, and to compare it with other add-on drugs. Furthermore, future research should consider rufinamide as add-on treatment for generalised epilepsies and as a single treatment in focal and generalised epilepsy.