Information for patients about the EpiNet–First Trials
We would like people who have recently been diagnosed with epilepsy, but who are not currently receiving an anti-epileptic drug, to consider participating in one of the EpiNet–First trials. There are 5 trials altogether, though they have a very similar design. Which trial a person enters is determined by the type of seizures they have. This will be decided by the person’s doctor. These are international studies.
Rationale
There are many drugs (medicines) which are available to treat patients with epilepsy. All of these drugs have been shown to be effective in reducing the likelihood of seizures, though they do not necessarily prevent all seizures in all patients. At the present time doctors do not know which of these drugs is best, or whether one of them works better for some people than another drug. The studies we are undertaking will help find out which of the various anti-epileptic drugs work best in people with new-onset epilepsy.
Study Design
If you have had two or more epileptic seizures, and your doctor thinks that you should start treatment with an anti-epileptic drug, then we would like you to take part in one of these trials. You would need to agree to take part in the study, and your doctor would need to think it was the right thing for you. Patients who take part will be randomly allocated to one of several different drugs. A computer programme will decide which drug patients receive. You can imagine this as being similar to the computer tossing a coin. This ensures that the groups receiving the different drugs are likely to contain very similar people. Therefore, if we find a difference in the outcome between the treatments, it will almost certainly be because one anti-epileptic drug is really better than the other drugs. The difference will not be because one group happened to contain people with less severe epilepsy. The drugs that we are studying are carbamazepine, lamotrigine, sodium valproate and levetiracetam. They have all been used to treat people with epilepsy for many years, and we know that they work well for most people. We are now trying to find out if one is better than the others. Patients who take part in these trials, and their doctors, will know what drug the patient is taking. We want doctors to report on their patients’ progress at particular times (3, 6 and 12 months and 2 years.) In particular, we will want to know whether patients have further seizures, and whether they experience side effects from the treatment. Patients will not need blood tests or any other samples taken for the study. Information will be entered into the EpiNet database using a secure website, similar to those that are used by banks. No material which could personally identify patients will be used in any reports on these studies. To ensure that the information we collect is meaningful, it is very important that patients do actually take the drug they are prescribed as reliably as possible. Patients can certainly stop the drug if they have troublesome side effects, or if they change their minds, but we need to know if they stop taking it. We could be badly misled if patients do not take the medication prescribed, and we do not know this, since we then will draw the wrong conclusion about the effectiveness of the different drugs. If you experience troublesome side effects, tell your doctor, and discuss with him or her whether you should continue it. It is also important that we get accurate information about patients’ seizures. We will want patients to keep a detailed record of any seizures they have while taking part in the study. It is also important that patients are followed for at least two years.
Risks and Benefits
Patients will not be put at any risk by taking part in this study. We will not be giving any experimental drugs. All the drugs that we are using are standard drugs that are known to be effective in people with epilepsy. However, there is still a small risk that a patient could have some sort of adverse reaction. For instance, it is possible that a patient could have an allergic reaction to a drug, though this risk will not be increased by taking part in the research study. Patients are likely to have the same risk even if they do not take part.
There will not be any costs, nor any payment, to patients who participate.
If you would like to take part in one of the EpiNet–First trials, then talk to your doctor about this.
Peter Bergin
For the EpiNet Study Group