Hi Brian, et al -
Monday morning I was at the KU Med Center for 3 hours as part of the
screening process for taking part in the drug trials. I was recruited by my
neuro (who is also responsible for this trial). I was interviewed by an RN;
given urine, blood, blood pressure, EKG, mental & mood tests; and kept dual
(for comparative purposes) diaries of my on-off times every half hour. I was
given a practice diary which I am keeping for three consecutive days and
mailing back.
Assuming we go on, there will be five more visits starting in 3 weeks. Then
I will randomly & blindly receive one of five doses of study tablets to be
taken twice a day--37.5 mg; 75 mg; 150 mg; 300 mg; or a Placebo. All the
tests will be repeated one or more times. If undesirable side effects occur,
the dosing can be adjusted and/or lowered.
In the USA & CAN, Astra Merck Inc. is sponsoring the test of the
experimental drug called remacemide hydrochloride (RH) in PWPs to see whether
it will SAFELY & EFFECTIVELY decrease some of the brain chemicals that causes
motor fluctuation (when going from "on" to "off"). About 275 subjects in 25
centers are expected to take part.
Risks include nausea, dizziness, etc. but the RAT FACTOR is what gives me
pause! Quoting-- "Other drugs that work by a mechanism similar to the
presumed mechanism of RH have been shown to produce nerve cell changes or
nerve cell death in specific regions of the rat brain. The clinical
significance of these effects in humans IS PRESENTLY UNKNOW [caps mine}.
High blood concentrations of RH metabolite have produced nerve cell
changes, but only very high concentrations have resulted death to the nerve
cells in the brains of rats. The blood concentrations of RH...in this study
are predicted not to reach {those} ...in rats."
Any thoughts out there on how conerned I should be with what I call the RAT
FACTOR? Based on pure size, isn't what would be a high concentration in a
rat be a relatively low concentration in a human?
Fellow USA list members. I hope we all have an enjoyable Thanksgiving and
can count our blessings, including the ever-expanding research frontier and
the Udall Bill!
Barbara Blake-Krebs (57, dx 1984) [log in to unmask]
Merriam, KS, USA (ltr after F is cap "i")
