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The Role of Clinical Trials in Epilepsy

Posted Aug 24 2008 1:49pm
ANNOUNCER: Epilepsy is usually treated through the use of anti-seizure medications. When an anti-seizure drug is being considered for use, it has to go through rigorous testing to show that the drug is both safe and effective. That testing is done through clinical trials. which tell researchers and physicians many things about a drug.

JACQUELINE FRENCH, MD: In the best of all possible worlds, clinical trials will tell us not only what type of seizures or epilepsy a drug is good for, but also what dose is the most appropriate to use, how the drug should be initially started, what the problems with the drug might be that a physician would have to look out for, because no drug is completely without potential side effects. And we need to know what those side effects are so we can warn our patients. And if done properly, hopefully a clinical trial can also tell us whether there are any serious safety concerns about the drug.

ANNOUNCER: However, there are also several things that clinical trials do not take into consideration.

JACQUELINE FRENCH, MD: Those things include, for certain epilepsy syndromes, whether that drug will be effective. So usually the clinical trials are performed in the population that is most easy to get together and to enroll into the trial, and also it's performed in the patients who are most likely to show a difference during the trial. And in addition, we want the trials to be done in a population that's reasonably similar one to the next, and therefore we tend to do the studies in the seizure types that are the most frequent.

There are fewer patients who suffer from other types of epilepsy syndromes, and therefore it's harder to get the type of patients together that are needed for a trial, so often those syndromes are not tested. So one does need to take the clinical trial results and look at them in relation to the type of patient that was tested in the trial.

ANNOUNCER: Because clinical trials have their weaknesses, physicians often find that once a medication is used in practice, its outcome can differ from the results of a clinical trial.

JACQUELINE FRENCH, MD: We often find that the results are somewhat different than what we've found in clinical trials. And the differences can be either on the good side or on the bad side. So although the trials give us a sense of what we're looking for, there can always be surprises when a drug is used in a broader population.

ANNOUNCER: Due to clinical trial activity over the last fifteen years, there are now many effective anti-seizure medications on the market. Recently, there has been a push to re-examine the potential benefit of the earlier medications.

JACQUELINE FRENCH, MD: There has been an increasing effort and interest in looking a little earlier in epilepsy and seeing whether those same drugs, which seemed to be effective in patients with refractory or uncontrolled seizures, would also be safe and effective in patients whose seizures have just been diagnosed. And whether these new drugs would add benefit compared to the five major drugs that were available in the past, which actually are the drugs that still over half of people with epilepsy are on.

So now there have been a lot of trials that have compared the older drugs with these newer drugs in newly diagnosed patients, and the reason to do those trials is to see whether the newer drugs are equally as effective in controlling seizures, but also, the hope is that the newer drugs will be better-tolerated than the older drugs.

ANNOUNCER: Head-to-head trials have yielded mixed results.

JACQUELINE FRENCH, MD: In the last few years, there have been head-to-head trials in newly diagnosed patients of the new drugs topiramate, lamotrigine, oxcarbazepine, gabapentin and levetiracetam. And although perhaps in our hearts, people who treat epilepsy would have hoped that one of these drugs would have turned out to be superior to the older drugs, in terms of controlling more seizures than the older drugs, it turns out that actually, in this population of newly diagnosed patients, the ability to control seizures of the newer drugs is essentially exactly the same.

The good news is that in each of these cases it has turned out that the newer drug has better tolerability in certain areas and does contribute to making people feel better compared to the older drugs.

ANNOUNCER: The findings from these trials have prompted physicians to re-evaluate their prescription choices.

JACQUELINE FRENCH, MD: Every patient's treatment is going to be individualized by their physician, and sometimes an older drug may be the better choice, and sometimes a newer drug may be a better choice.

ANNOUNCER: So what is the bottom line when evaluating clinical trial data?

JACQUELINE FRENCH, MD: Sometimes the information from randomized trials doesn't tell you how to treat in practice, and sometimes the evidence from randomized trials is not available to tell you how to treat in practice.

In the end, there is a patient and there is a physician, and the physician has to address the needs of one particular patient sitting in front of them. They can use the evidence from randomized, controlled trials, but they also have to use the art of medicine to improve that person's lot as much as they can.

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