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------Original Message------------- Date: Sat, 7 Dec 1996 00:47:23 -0500 From: "Brian C.Black" <[log in to unmask]> Subject: New Drug :Tolcopone Help, I feel like a blindfolded guineu pig! I have just signed on to the first stage of an experiment with a drug called Tolcopone and I would be very greatful for any info on this drug. I know it has been successfully administered to about 800 people in doses upto 800 mg,. I am also aware of some potential side-effects such as diarrhea, headaches, dizziness and nausea. This first stage is just a daily diary to see if I am suitable for the experiment. It's a " double-blind (as in "blindfolded guinea pig!"), randomized, crossover study in patients treated with Prolopa or Senemet who exibit end of dose wearing off." I accepted the role of gineau pig because I trust my neuro, it sounds like an ideal drug for me, and most of all, because I'm desperate. My offs have become more frequent , longer , and more intense recently, and this seemed like a ray of hope in this dark tunnel we call Parkinson's. ----------REPLY-------------- Brian, I can't give you any information on the drug but hopefully ease any doubts you have. When a newe drug is developed it is first tested on animals that have an immune system similar to humans (lab rats). If there are no complications the drug is then administered to healthy volunteers in increasing amounts to determine side-effects. Generally speaking no public information is given out on these priliminary tests. I assume that the 800 people you mentioned were priliminary test subjects. Once the drug has proven safe for human consumption then the actual experiment to test the effeectiveness of the drug is conducted. In Phase I volunteers who have the targeted condition are randomly assigned to two groups-- treatment and control. The treatment group receives the real stuff, the control group receives a placebo. This is always a blind study which means that the participant does not know whether they are taking the actual drug or the placebo. This is done to eliminate the "placebo effect"-- where a person who thinks he is getting effective treatment will actually improve even though in reality the treatment has no effect. Of course, someone must evaluate the condition of the participants and usually they are also "blind" to whether or not the participant is in the treatment or control group. This is done to eliminate the "expectation effect"-- where the investigator sees indications of improvement because they expect to see them. Hence the term "double blind". This is why you haven't heard anything about the drug yet. You are probably in the first Phase I group and therefor will be the one giving the rest of us the information! Phase I studies usually last 9 - 12 months. These are usually followed by Phase II studies which are to determine the long-term effects of the drug. Phase II usually lasts for at least three years and all participants receive the real medication. The investigaors are selected for their knowlege of the target disease so you can be assured that they are well qualified. You will be closely monitored during the first few weeks of the trial. If you are in the treatment group you will start out on a very low dosage which will be slowly increaed (a process called titration) up to the maximum called for in the protocol. (Speaking of which, you should receive a copy of the protocal). Being a researcher myself, I volunteer for as many PD trials as I can. I particpated in Phase I for Ropinerol and am currently in Phase II for Pramipexole. Although there is a slight chance of really bad (permanent) side effects, that chance usually is just a little higher than with drugs already on the market. I hope that this explanation of how clinical trials are conducted has allsyed any doubts you have. In fact there are many who claim that American drug companies are too cautious in their trials. Bruce 55/8 Sinemet CR & Pramipexole ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ Bruce G. Warr, Ph.D. "Experience is what enables us to recognize Healthcare Informatics Lab a mistake the next time we make it." Information Systems Dept. University of Maryland Baltimore County http://umbc.edu/~warr/ (V) (410)455-3206 (F) (410)455-1073 ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~