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The Role of Clinical Trials in Epilepsy

Summary & Participants

Before anti-seizure drugs are approved for use, they go through rigorous testing. But do these trials tell us everything we need to know? Learn what doctors are saying about the real world experience of epilepsy medications.

Medically Reviewed On: July 09, 2008

Webcast Transcript

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.

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