Did you know how long it takes for a new treatment for epilepsy to be tested and approved? The average for neurological drugs is almost 13 years from the first testing in humans to FDA approval and availability at your local pharmacy. Why does it take so long? We understand that testing requires very careful evaluation of safety as well as determination that the treatment is effective. This requires several stages of clinical trials, each lasting several years.
Did you know that you can improve this timeline? The biggest roadblock in testing new treatments is finding patients willing to participate in clinical trials. It’s not easy to find patients who are eligible for these studies so the recruitment phase often lasts more than two years for each clinical trial. Testing new treatments usually is done by asking patients who have many seizures and have already tried many drugs to enroll with the opportunity to receive either the new treatment added onto current therapy or a placebo added onto current therapy. Most studies are brief, lasting only three to four months, after which all patients are offered the new treatment. Therefore, people who received the placebo initially can have a new therapy after this brief introductory phase.
Why does it take so long to find people who are having many seizures when there are millions of people with epilepsy? Clinical trials must be limited to people with specific types of seizures, minimum frequency of seizures (usually at least four partial-onset seizures per month), and be in excellent health. In addition, patients must be willing to visit the study center frequently during the follow-up period for free care. Not every doctor can and enroll patients into every clinical trial, so people willing to participate in studies must be referred to the doctor in their area who is conducting the clinical trial. Although patients are followed by the study doctor for the duration of the clinical trial, they return to their own doctor at the conclusion of the study.
What can you do to help speed the development of new treatments for epilepsy? Enrolling in a clinical trial for which you are eligible might provide you with improved seizure control and certainly will help others when we understand the usefulness of a new treatment. The first place to look for a clinical trial is on our website at http://my.epilepsy.com/clinical_trials where you can find studies being conducted in your area. A video in which I interview Dr. Morrell provides a description of a clinical trial of the RNS Neurostimulator may be seen at http://my.epilepsy.com/node/976507 . This brain stimulating device is being tested with adults who have frequent partial-onset seizures at 29 centers across the
Success! Retigabine is an example of a new antiepileptic drug that has been tested in clinical trials since 1997 over the years: Enough testing has been completed with retigabine to be ready to request approval by the FDA. Almost 1600 patients participated in these studies over the years. It will take another year before we take a being is in your pharmacy, if approved as expected.
I am excited to see another antiepileptic drug move toward approval so the epilepsy community will have another treatment for seizures. I also am pleased to see that two companies (Valeant and Glaxo Smith Kline) will share in developing this compound to make it available around the world. I look forward to additional epilepsy treatments (drugs and brain stimulating devices) being approved in the near future. We need even more therapies to help those who have not yet achieved seizure control.
Wishing everyone “freedom from seizures” as soon as possible,
President, Epilepsy Therapy Project