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-----Oorspronkelijk bericht----- Van: Bill Innanen <[log in to unmask]> Aan: [log in to unmask] <[log in to unmask]> Datum: maandag 20 maart 2000 17:16 Onderwerp: FYI: Riluzole trials >>>>> Here's an article on Riluzole trials: http://www.ivanhoe.com/docs/thisweekonly/slowingparkinsonsqa.html <<<<< What is Riluzole? Dr. Gollump: Riluzole is a drug we know inhibits the release of a substance called glutamate in the brain. We think that by inhibiting the release of that substance, you can prevent certain types of damage to nerve cells in the brain as a consequence. When was it FDA approved for Lou Gehrig's Disease? Dr. Gollump: It was approved about two-and-a-half years ago. Is there evidence that Riluzole can help Parkinson's patients, or is that what this study is all about? Dr. Gollump: That's what this study is all about. There is evidence in animal trials that it may help the Parkinson's disease patient. What evidence in the animal trials showed it helps Parkinson's? What kind of symptoms did it ease? Dr. Gollump: It's not so much symptoms, but it seemed to improve the loss of cells in the part of the brain involved in Parkinson's disease. Of course we don't have a true animal example of naturally occurring Parkinson's disease, but we simulate it in the animal. Through various techniques we can improve the outcome. Does it delay the progression of it? Dr. Gollump: It decreases cell loss, which would imply delay of progression. In the animal it isn't quite the same thing. It isn't an ongoing disorder. Do we know if it works the same way on Lou Gehrig's patients as it does in Parkinson's patients, or does it work differently? Dr. Gollump: We presume that it may. Of course we don't know for sure whether it works on Parkinson's patients or not just yet. What are these new studies about? Dr. Gollump: Both of these studies are using Riluzole. Study one looks at patients who have never been treated for their Parkinson's disease. We're looking for people who are fairly early in the disease development. What we're hoping to demonstrate over a period of time is that their outcome, after using Riluzole, is better at the end years than people who have not been treated with the compound. Study two involves patients who have already been started on one of the major anti-Parkinson's medications. We're looking at this group to see whether they are going to eventually need two anti-Parkinson's medications over approximately a two-year time window. Will the study involve a placebo? Dr. Gollump: The study is designed where there are three groups, a placebo group and two different active dose levels for the drug. Everyone is blinded as to which group assignment each patient is in, and they're in the same group from the beginning of the study to the end. Does Riluzole cause any side effects in Lou Gehrig's patients; could there be same side effects in Parkinson's patients? Dr. Gollump: Yes. It could be possible. Fortunately the side affects are mild, but a side effect noted in the Lou Gehrig's population was some drowsiness. We have certainly seen drowsiness in some of the Parkinson's patients so far. Whether they were on the active drug or not, we don't know, but we've certainly seen it. The other concern is the effects on the chemistries of the liver, which was also seen in the Lou Gehrig's population. That's not a serious problem and didn't cause any serious difficulties. However when you're studying a drug for a new application, the FDA requires you to monitor liver studies, especially since we already knew that mild liver abnormalities were induced in the Lou Gehrig's population. How much is the dose of Riluzole in this study? Dr. Gollump: It's two pills, twice a day. Is that the same as Lou Gehrig's patients? Dr. Gollump: Yes. What does Riluzole do to the body? Dr. Gollump: What it does in the body is inhibits the release of a neurotransmitter called glutamate. Glutamate is a stimulatory neurotransmitter -- what that means is, it turns nerve cells on and activates them. Normally we need active nerve cells for our systems to work properly. However, in settings where cells are weak from disease, that may not be the ideal. Turning them on may actually cause them to exhaust themselves metabolically. This is believed to be how it works in the setting of Lou Gehrig's disease. By inhibiting the release of glutamate, Riluzole inhibits the over-activation of cells that are already damaged. Obviously the supposition is this may also be beneficial in the setting of Parkinson's disease, too. How important is this study to Parkinson's disease patients? Dr. Gollump: I think it's very important because we can understand where the site of the disease is and know what cells are involved in the brain. We have very effective therapy for the symptoms of Parkinson's Disease, but as effective as that therapy is, it's not perfect and the disease itself certainly continues to progress beneath the treatment. Though we can cover symptoms over a period of five to 10 years, the disease clearly becomes more clinically obvious and demands more interventions. It makes life more difficult for people so affected. If we can slow or hold the progression of the disorder, we're one step closer to more effectively treating the disease. The ideal would be to totally replace the damaged cells or rejuvenate them. We don't know how to do that yet. However, this interim step looks very promising and we have several compounds that we're looking at that have similar types of properties. Riluzole is the one that's furthest along. What else would you like to point out? Dr. Gollump: I would emphasize that Riluzole does not have any therapeutic benefit for the symptoms of Parkinson's disease. In other words, if someone were to take it, it would not make their Parkinson's disease any better. We know we're not going to see any effect on Parkinson's disease in our blinded population. What we're hoping is a few years out, they will be better off if they were on the drug than they may have been without it. END OF INTERVIEW