At 12:47 AM 12/7/96 -0500, you wrote:
>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 up
>to 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."
Brian, Tasmar/tolcapone in the first two phases of clinical trials has shown it to be effective across the spectrum of Parkinson's patients.
The trial you and others are participating in is the Phase III trial where it it tested on particular patients of a common age group and stage of illness taking certain other parkinsonian medications. Phase III determines what dosage with fewest side effects is proper...depending on the population's demographics.
In a Phase III Trial, you will either be given a progressive dose of placebos or tolcapone....with a washout period and then the same sequence with either placebo or tolcapone. There will be times in the trial that you may feel overmedicated.....this has a purpose, as well as times when you feel undermedicated. Phase III trials determine...on average what a proper dose needs to be with the fewest side effects for your group that are 'wearing off.'
Roche Pharmaceuticals thought they would get FDA approval for Tasmar this year....if not surely next.
[log in to unmask] That man may last, but never lives,
Who much receives, but nothing gives;
HomeBoy #Parkinsons Whom none can love, whom none can thank,--
Creation's blot, creation's blank.
John Cottingham Thomas Gibbons (1720-1785): When Jesus dwelt.
