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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

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